[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-macular-edema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-macular-edema":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,46,69,91,114,148,177,192,215,241,268,290,324,345,367,408,434,457,489,526,554,574,598,625,644],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100570013","phase-1-a-study-intravitreal-thn391-in-diabetic-macular-oedema-secondary-to-non-proliferative-diabetic-retinopathy-100570013",false,"NCT06701721","A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.","A Phase 1b Open-Label, Multiple Ascending Dose Study of the Safety, Tolerability, and Biological Activity of Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.","Inclusion Criteria:\n\n* Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity\n* 18 to 80 years of age (inclusive at the time of informed consent).\n* Diagnosis of Diabetic Macular Edema (DME)\n* Vision loss in the study eye\n\nExclusion Criteria:\n\n* Be pregnant or breastfeeding\n* Cataract surgery or any other previous ocular surgery in the study eye within 3 months before Screening\n* Any other condition except for DME that could affect interpretation of study assessments","ALL","18 Years","80 Years",{"count":21,"type":22},21,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","THN391-OPT-101 is a study assessing safety and preliminary efficacy of THN391 in patients with diabetic macular edema (DME) given as monotherapy.",[28,29],"Diabetic Macular Edema","Diabetic Retinopathy",[31,32],"Diabetic Macular Oedema","Non-proliferative Diabetic Retinopathy","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2024-12-20",{"date":41,"type":22},"2027-05-31",{"name":43,"class":44},"Therini Bio Pty Ltd","INDUSTRY",7,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100635495","phase-1-a-study-in-people-with-diabetic-macular-edema-to-test-how-well-different-doses-of-bi-3812465-are-tolerated-100635495","NCT07553429","A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated","A First-in-human, Open-label (Part 1), Randomized (Part 2), Phase I\u002FIIa Trial to Study Safety and Tolerability of Multiple Rising Intravitreal Doses of BI 3812465 in Patients With Center-involved Diabetic Macular Edema","Inclusion Criteria:\n\nAll participants, study eye:\n\n* Center-involved diabetic macular edema (CI-DME) defined as CST ≥320 μm (micrometers) at Screening, as confirmed on spectral-domain optical coherence tomography (SD-OCT) and confirmed by the central reading center (CRC).\n* Sufficiently clear ocular media, adequate pupillary dilation, and fixation, to permit quality fundus imaging.\n\nAll participants:\n\n* Diagnosis of diabetes mellitus (DM) type 1 or type 2 under regular treatment, with glycated hemoglobin HbA1c \\\u003C12%.\n* Be willing and able to understand the study procedures and the risks involved.\n* Signed and dated written informed consent in accordance with international council for harmonization - good clinical practices (ICH-GCP) and local legislation prior to admission to the trial and any trial related procedures.\n* Age ≥18 years (or above legal age according to local legislation) at time of signing the informed consent form (ICF).\n* Male or female participants\n\n  * Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control\n  * For men, contraception (condom or complete abstinence) should be used as precaution to prevent pregnancy of a partner and\u002For exposure of an existing embryo or fetus.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\nAll participants, study eye:\n\n* Only one functional eye, even if that eye was otherwise eligible for the study. Fellow eye must have sufficient visual function per the investigator's medical judgment in consultation with the participant, to support the participant's daily functioning.\n* Evidence of active proliferative diabetic retinopathy (PDR).\n* Evidence of active retinal neovascularization (NV) clinical exam and\u002For Ultra-Widefield Color Fundus Photography ((UWF-)CFP) within the early treatment diabetic retinopathy study (ETDRS) 7-field, confirmed by the CRC grading. Potential participants with NV outside of the ETDRS 7-field on ultra-widefield imaging may be included in the trial if this condition, based on the assessment of the investigator, does not require acute treatment.\n* Evidence of active NV of the iris (small iris tufts are not an exclusion) or in the anterior chamber angle.\n* Additional eye disease in the study eye that could compromise trial participation:\n\n  * Uncontrolled glaucoma or intraocular pressure (IOP) \\>24 mmHg despite treatment\n  * History of high myopia \\>8 diopters in the study eye\n  * Anterior segment and vitreous abnormalities in the study eye that would preclude adequate detection of intraocular inflammation (IOI) or other pathologies\n  * Ocular conditions which, at discretion of the investigator, might interfere with the outcome of the trial.\n* Previously received ocular gene therapy or cell therapy.\n* Corticosteroid use locally or systemically within 1 month prior to Screening.\n* Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy may be permitted, if performed more than 2 months prior to Day 1.\n\nFurther exclusion criteria apply.",{"count":54,"type":22},49,[25,56],"PHASE2","This study is open to adults with diabetic macular edema that involves the center of the eye. The purpose of this study is to find out how well different doses of a medicine called BI 3812465 are tolerated by people with this condition. This is the first time BI 3812465 is given to humans.\n\nThis study has 2 parts. In Part 1, a small number of participants receive low, medium, or high doses of BI 3812465. The first participants to start the study get low doses of BI 3812465. Participants who start later get higher doses only if the lower doses were tolerated. In Part 2, a larger number of participants are placed into low, medium, or high dose groups. Participants in both parts of the study get BI 3812465 as injections into the back of the eye for a total of 3 eye injections.\n\nParticipants are in the study for up to 7 months. During this time, they visit the study site 19 times. Where possible, some visits can be done at the participant's home instead of the study site. At study visits, the doctors check the severity of participants' eye condition and note any health problems that could have been caused by BI 3812465.",[28],"2026-06-22",{"date":61,"type":37},"2026-06-23",{"date":63,"type":37},"2026-05-14",{"date":65,"type":22},"2027-07-06",{"name":67,"class":44},"Boehringer Ingelheim",30,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100625660","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacodynamics-and-pharmacokinetics-of-ro7823653-in-participants-with-diabetic-macular-edema-dme-100625660","NCT07425522","A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)","A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema","Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and\u002For American Diabetes Association\n* Glycated hemoglobin (HbA1c) \\\u003C= 12%\n* For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) \\>= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters\n\nExclusion Criteria:\n\n* Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required\n* Uncontrolled blood pressure\n* For Parts 1 and 2: Any history of ocular injection\u002Fimplant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF\u002Fanti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant.\n* For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant\n* History of uveitis, vitritis (grade trace or above), and\u002For scleritis in either eye\n* Active intraocular inflammation in either eye\n* Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye",{"count":77,"type":22},93,[25],"The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.",[28],"2026-06-16",{"date":83,"type":37},"2026-06-18",{"date":85,"type":37},"2026-04-21",{"date":87,"type":22},"2028-11-17",{"name":89,"class":44},"Genentech, Inc.",10,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100568407","a-real-world-study-to-gain-clinical-insights-into-faricimab-fareal-study-100568407","NCT06680817","A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)","Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)","Inclusion Criteria:\n\n* Patients receiving faricimab according to the local faricimab product label and who have initiated treatment with faricimab at time of the ICF signature date or no more than 3 months prior to the ICF signature date, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye\n* Patients have received at least one faricimab treatment (the first dose) in the study eye\n* Patients should have available data for visual acuity (VA) and Central Subfield Thickness (CST) for the Baseline level (i.e. examinations to be performed at the index date or within 4 months prior to it)\n\nExclusion Criteria:\n\n* Patient participation in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to the ICF signature date\n* Concomitant participation in any interventional clinical study\n* Active ocular inflammation and\u002For suspected\u002Factive ocular infection in either eye\n* Patients treated with faricimab who have and are currently participating in patient support programs (PSP) that are Market Research and Patient Support Programs (MAP) including Post Trial Access Programs (PTAP) and Compassionate Use Programs (CUP)\n* Patients with non-ocular sight threatening disease which have an effect on the primary endpoint (e.g., apoplexia)\n* Hypersensitivity to the active substance or any of the excipients of Vabysmo (as per label)",{"count":99,"type":22},850,"OBSERVATIONAL","The FaReal study aims to evaluate the effectiveness, safety, clinical insights and treatment patterns in patients treated with faricimab, in neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in at least one eye, in real-world routine clinical practice over a 2-year patient follow-up period. Additionally, the FaReal study also aims to describe and evaluate health economic aspects of previous anti-VEGF treatments and current treatment with faricimab.",[103,28],"Neovascular Age-related Macular Degeneration","2026-06-05",{"date":106,"type":37},"2026-06-09",{"date":108,"type":37},"2025-02-05",{"date":110,"type":22},"2028-06-30",{"name":112,"class":44},"Hoffmann-La Roche",59,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":147},"100563021","home--vs-hospital-based-care-of-anti-vegf-treatment-for-diabetic-macular-edema-non-inferiority-rct-100563021","NCT06610747","Home- vs Hospital-based Care of Anti-VEGF Treatment for Diabetic Macular Edema: Non-inferiority RCT","Home Care Monitoring of Visual Acuity and OCT Versus Standard Hospital\u002FClinic Care Monitoring During Diabetic Macular Edema Management: A Non-inferiority Randomized Clinical Trial","DME HOME","Participant-level Criteria:\n\nInclusion Criteria:\n\nTo be eligible, the following inclusion criteria must be met:\n\n* Age of 18 years or older;\n* Type 1 or type 2 diabetes mellitus\n* Current regular use of insulin for the treatment of diabetes or current regular use of oral anti-hyperglycemia agents for the treatment of diabetes\n* Travel time from home to the hospital\u002Fclinic within a 2-hour driving distance\n* At least one eye meets the study eye criteria listed in Section 2.4\n* Ability and willingness to operate the self-administrated visual acuity tester and Home OCT device by themselves or with the help of family after training\n* Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\nAn individual is not eligible if any of the following exclusion criteria are present:\n\n* Conditions that would preclude participation in the study, such as unstable medical status including blood pressure, cardiovascular disease, renal disease, and glycemic control as determined by the investigators\n* History of systemic anti-VEGF or pro-VEGF treatment within 4 months before randomization. These drugs should not be used during the study;\n* In an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied\n* Blood pressure \\> 180\u002F110 (systolic above 180 or diastolic above 110. If blood pressure is brought below 180\u002F110 by anti-hypertensive treatment, then the individual may be eligible\n* History of myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months before enrollment\n* For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 2 years. Women who are potential study participants should be questioned about the potential for pregnancy, and the investigator will determine when a pregnancy test is needed\n* Currently participating in other clinical trials\n* The individual who might move out to an area beyond 2-hour driving distance during the first 12 months of the study\n\nStudy eye-level Criteria:\n\nThe participant must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below. Participants can have only one study eye. If both eyes are eligible at the time of enrollment and one of the eyes has never received anti-VEGF treatment, that eye should be included. If both eyes are eligible and have previously received anti-VEGF treatment or both eyes have never received anti-VEGF, then the better-seeing eye will be selected before enrollment. If neither eligible eye is the better-seeing eye, then the investigator and participant will select the study eye by mutual agreement before enrollment.The definition of better-seeing, worse-seeing and same eye is in the followings:\n\n* If the baseline visual acuity letter score in both eyes is 50 (20\u002F100) or better, the better-seeing eye is the eye with better baseline visual acuity (better than that of the fellow eye by 5 letters or more), and the worse-seeing eye is the eye with worse baseline visual acuity (worse than that of the fellow eye by 5 letters or more); if the baseline visual acuity of one eye is within 4 letters of that of the fellow eye, the two eyes are the same and neither eye is the better-seeing eye.\n* If the baseline visual acuity letter score in both eyes is \\< 50 (20\u002F100), the better-seeing eye is the eye with better baseline visual acuity (better than that of the fellow eye by 10 letters or more), and the worse-seeing eye is the eye with worse baseline visual acuity (worse than that of the fellow eye by 10 letters or more); if the baseline visual acuity of study eye is within 9 letters of that of the fellow eye, the two eyes are the same and neither eye is the better-seeing eye.\n\nThe eligibility criteria for a study eye are as follows:\n\nInclusion Criteria:\n\n* Central-involved DME (central subfield thickness on OCT defined on Heidelberg Spectralis OCT 320 μm or more in men and 305 μm or more in women, or Zeiss Cirrus OCT 305 μm or more in men and 290 μm or more in women, or the equivalent on spectral-domain OCT based on gender specific cutoffs)\n* Best corrected visual acuity letter score ≤ 78 (i.e., 20\u002F32 or worse) and ≥ 24 (i.e., 20\u002F320 or better) within seven days of inclusion\n* Received no treatment for DME before, or received no anti-VEGF injection for DME within the past 3 months; however, if there is a history of anti-VEGF injections, \\\u003C=1 injection in the past year and \\\u003C=3 injections over the study participant's lifetime); or, \\\u003C=2 monthly injections within the past 3 months and \\\u003C=3 injections over the past year, and \\\u003C=6 injections over the study participant's lifetime.\n* Sufficient media clarity, pupillary dilation, and individual cooperation to allow for adequate fundus photographs and adequate OCT\n\nExclusion Criteria:\n\nThe following exclusions apply to the study eye only (i.e., they may be present for the non-study eye):\n\n* Macular edema due to reasons other than diabetes\n* Any history of prior laser, other surgical or corticosteroid treatment for DME (such as focal\u002Fgrid macular photocoagulation, intravitreal corticosteroids or peribulbar corticosteroids) within the prior 12 months\n* History of intravitreal anti-VEGF for an ocular condition other than DME (e.g., choroidal neovascularization, central retinal vein occlusion, PDR) within the prior 6 months or anticipated need in the next 6 months\n* Coexisting ocular diseases that might alter visual acuity during the course of the study, such as a retinal vein or artery occlusion, uveitis or other ocular inflammatory diseases, neovascular glaucoma, etc.\n* A substantial cataract that, in the investigator's opinion, is likely to be decreasing visual acuity by 3 lines or more. This means that the cataract would be reducing acuity to 20\u002F40 or worse if the eye were otherwise normal\n* History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckling, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization\n* Uncontrolled glaucoma\n* Severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.",{"count":123,"type":22},308,[125],"NA","Diabetic macular edema (DME) is a common cause of central visual loss in diabetic patients and a global public health burden around the world. Most patients with DME and vision loss require pharmacological inhibition using anti-VEGF agents with multiple monitoring visits that require both visual acuity testing and optical coherence tomography (OCT) to determine if re-treatment is warranted as well as the recommended time interval to the next follow-up visit. However, this treatment regimen often requires monthly or every other month clinic visits, which places a substantial burden on ophthalmic clinics and patients.\n\nRecently, portable self-administered Home OCT devices have been developed that allow for home-based OCT scanning of retinal diseases, e.g., DME, although these devices do not include visual acuity determination. The investigators previously proposed to deliver Home OCT devices and Home visual acuity tester to patients\\' homes to complete routine monitoring visits at home. However, there is a lack of evidence regarding the safety and efficacy of this novel monitoring regimen for DME patients, specifically whether its use could reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes.\n\nThis study aims to provide evidence to support use of a novel monitoring regimen for DME patients that could substantially reduce the burden associated with frequent hospital visits without sacrificing visual acuity outcomes.",[28],[129,130,131,132,133,134,135,136,137],"Diabetic macular edema","Diabetic retinopathy","Aflibercept","Anti-VEGF","Home care monitoring","Home OCT","Best-corrected visual acuity","Visit burden","Randomized clinical trial",{"date":139,"type":37},"2026-06-08",{"date":141,"type":37},"2024-10-28",{"date":143,"type":22},"2027-04-30",{"name":145,"class":146},"Zhongshan Ophthalmic Center, Sun Yat-sen University","OTHER",4,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100627538","phase-3-como-a-phase-3-randomized-double-masked-study-comparing-the-efficacy-of-eyp-1901-against-aflibercept-in-dme-100627538","NCT07449936","COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME","A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)","DME","Inclusion Criteria:\n\n* Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit.\n* Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20\u002F200 Snellen equivalent) to 78 letters (20\u002F32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1).\n* For previously treated participants: at least 1 injection of anti-VEGF in the past 12 months, the most recent anti-VEGF treatment for DME must not have been administered less than 12 weeks prior to the Screening Visit.\n\nExclusion Criteria:\n\n* BCVA using ETDRS charts \\\u003C30 letters (20\u002F250 Snellen equivalent) in the fellow eye.",{"count":157,"type":22},240,[159],"PHASE3","This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.",[28,154,162],"Diabetic Macular Edema (DME)",[164,165,166,28],"EyePoint","EYP-1901","Tyrosine Kinase Inhibitor","2026-06-01",{"date":169,"type":37},"2026-06-03",{"date":171,"type":37},"2026-02-16",{"date":173,"type":22},"2028-10",{"name":175,"class":44},"EyePoint Pharmaceuticals, Inc.",65,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":160,"conditions":184,"keywords":185,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":190,"locationsCount":191},"100627537","phase-3-capri-a-phase-3-randomized-double-masked-study-comparing-the-efficacy-of-eyp-1901-against-aflibercept-in-dme-100627537","NCT07449923","CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME",{"count":157,"type":22},[159],[28,154,162],[164,166,28,165],{"date":169,"type":37},{"date":188,"type":37},"2026-02-09",{"date":173,"type":22},{"name":175,"class":44},62,{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":4},"100638896","a-study-to-assess-the-use-of-artificial-intellignce-to-predict-eye-treatment-changes-in-adult-participants-with-diabetic-macular-edema-100638896","NCT07604545","A Study to Assess the Use of Artificial Intellignce to Predict Eye Treatment Changes in Adult Participants With Diabetic Macular Edema","Predictive Value of OCT Inflammatory Biomarkers in DME Using AI Analysis","OPTIMAL-3","Inclusion Criteria:\n\n* Previously untreated Diabetic macular edema (DME) Participants.\n* Baseline macular edema ≥350 microns confirmed on Spectralis Standard deviation (SD)-Optical coherence tomography (OCT) or equivalent.\n* Baseline Best corrected visual acuity (BCVA) between 23 and 78 Early treatment diabetic retinopathy study (ETDRS) letters (between 20\u002F32 and 20\u002F230 Snellen).\n\nExclusion Criteria:\n\n* History of eyes with previous intravitreal or laser treatment for DME.\n* History of eyes with previous intraocular or periocular corticosteroid for DME.\n* History eyes with other macular disease, causing visual reduction or disturbance.",{"count":201,"type":22},554,"This study is to assess the use of Artificial intellignce (AI) to predict eye treatment changes in adult participants with diabetic macular edema (DME).",[28],[28],"NOT_YET_RECRUITING","2026-05-18",{"date":208,"type":37},"2026-05-22",{"date":210,"type":22},"2026-05-30",{"date":212,"type":22},"2027-03",{"name":214,"class":44},"AbbVie",{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100622444","phase-2-lactiplantibacillus-plantarum-299v-probiotic-supplementation-in-patients-with-diabetic-macular-edema-100622444","NCT07383701","Lactiplantibacillus Plantarum 299v Probiotic Supplementation in Patients With Diabetic Macular Edema","Lactiplantibacillus Plantarum 299v Probiotic Probiotic Supplementation in Patients With Diabetic Macular Edema","Inclusion Criteria:\n\n* Age of at least 18 years, presence of DME at the current clinical visit\n\nExclusion Criteria:\n\n* Patients with contraindication to probiotic supplement (e.g. prior allergy or GI intolerance and any type of immunocompromised diseases).",{"count":223,"type":22},36,[56],"This pilot prospective, interventional, longitudinal study, aims to evaluate the potential benefits of the probiotic supplement Lactobacillus plantarum 299v in patients with diabetic macular edema (DME).\n\nThe study seeks to address the following questions:\n\n1. Does central macular thickness on optical coherence tomography decrease after 4 months of supplementation?\n2. Is visual acuity improved at 1, 2, 3, and 4 months following initiation of supplementation?\n3. Is the number of anti-VEGF injections reduced following initiation of supplementation?\n\nOutcomes will be compared to a control group, using historic retrospective data.\n\nParticipants will take Lactobacillus plantarum 299v orally twice daily for four months.",[28],[228,229,230],"diabetic macular edema","Lactiplantibacillus plantarum 299v","probiotic","2026-05-17",{"date":233,"type":37},"2026-05-19",{"date":235,"type":22},"2026-08-01",{"date":237,"type":22},"2027-09-01",{"name":239,"class":146},"Massachusetts Eye and Ear Infirmary",1,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":256,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":4},"100636608","effectiveness-of-multidisciplinary-protocolised-interventions-on-ivt-non-adherence-rates-100636608","NCT07567898","Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates","The Effectiveness of Multidisciplinary Protocolised Interventions to Reduce Non-adherencE Rates (ADHERE) in Patients With Chronic Macula Diseases Receiving Intravitreal Injections: A Randomised Controlled Trial","ADHERE","Inclusion Criteria:\n\n* Patients with chronic macula disease including those diagnosed with nAMD and DME, who require IVT.\n* This would include treatment naive patients (no IVT in either eye the last 6 months) and previously treated patients who have had IVT in either eye in the last 6 months and require further IVT treatment at the baseline study visit in either eye.\n* Able to provide informed consent and must consent to undergoing the MPI intervention.\n* Speak English or Mandarin.\n* Must be a Singapore resident.\n\nExclusion Criteria:\n\n* Patients who are unwilling or unable to perform CAT testing.\n* Unable to provide informed consent.\n* Significant eye pathology such as cornea problems, glaucoma, or other retinal diseases that may substantially affect vision.\n* Do not speak English or Mandarin fluently.\n* Cognitive impairment (as assessed using 6CIT).\n* Obvious observable physical or hearing disabilities that prevents them from completing the CAT questionnaire and undergoing MPI effectively.",{"count":250,"type":22},200,[125],"The purpose of this research study is to test whether a personalised care approach improves adherence compared to standard care. Many patients with macular diseases like age-related macular degeneration and diabetic macular edema need regular eye injections to protect their vision. However, some do not adhere to their treatment appointments, risking further vision loss.\n\nYou were selected as a possible participant in this research study because you have been diagnosed with neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) requiring intravitreal injection treatment (IVT).\n\nThis research study targets to recruit 200 participants from the Singapore National Eye Centre.\n\nThis study comprises two cohort groups: Cohort 1(Suboptimal CAT scores\u002F Randomized Control trial) and Cohort 2 (Optimal CAT scores\u002FObservation).\n\nIf you agree to take part in this study, the research coordinator will obtain your written consent before proceeding with the study procedures. You will be required to complete CAT assessment (via remote or administered in clinic) and assigned to cohort 1 or cohort 2 based on CAT scores result. If you are assigned to cohort 1, you will be randomly allocated to either the personalized multi-disciplinary protocolized intervention (MPI) or standard care group. Randomization means assigning you to one of two groups by chance, like tossing a coin or rolling a dice.\n\n* MPI group: You will complete a specialized computerized adaptive testing (CAT) quality of life questionnaire. Based on the domain specific scores, you will receive a medical consultation and a referral to nurse educators, optometrists, occupational therapists, or social workers.\n* Standard care group: If you are allocated to this group, you will receive standard care, where doctors make treatment decisions without using the CAT results.\n\nIf you are assigned to cohort 2, you will be placed under prospective observation and undergo routine clinical care.",[28,254,255],"Neovascular (Wet) Age-Related Macular Degeneration","Intravitreal Injection",[257,258],"ADHERE, Macular diseases, Intravitreal injections.","neovascular age-related macular","2026-04-28",{"date":261,"type":37},"2026-05-05",{"date":263,"type":22},"2026-04",{"date":265,"type":22},"2028-09",{"name":267,"class":146},"Singapore Eye Research Institute",{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":240},"100630550","phase-3-clinical-study-to-compare-efficacy-and-safety-of-avt29-and-eylea-hd-in-participants-with-diabetic-macular-edema-100630550","NCT07489131","Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema","A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared With Eylea HD in Participants With Diabetic Macular Edema","ALVOEYE-HD","Main Inclusion Criteria:\n\n* Participant is ≥18 years old at the time of signing the ICF.\n* Participant is willing and able to comply with all study procedures and likely to complete the study, based on the investigator's judgment.\n* Participant has a diagnosis of DME secondary to DM with central involvement in the study eye.\n* Participant has a BCVA ETDRS letter score of 73 to 34 letters inclusive (20\u002F40 to 20\u002F200 Snellen equivalent) in the study eye at screening and on Day 1 prior randomization.\n* Participant's decrease in vision is determined to be primarily the result of DME in the study eye.\n\nMain Exclusion Criteria:\n\n* previous treatment with anti-VEGF therapy\n* history or concurrent disease other than DME that could compromise visual acuity\n* Any condition that, in the Investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data\n* participants not suitable for participation, whatever the reason, as judged by the Investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.",{"count":277,"type":22},256,[159],"This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema.",[28],"2026-04-27",{"date":283,"type":37},"2026-04-30",{"date":285,"type":37},"2026-04-22",{"date":287,"type":22},"2028-01",{"name":289,"class":44},"Alvotech Swiss AG",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":306,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100629963","speculum-free-intravitreal-injection-using-cotton-tipped-applicator-retraction-a-randomized-trial-of-pain-procedure-time-patient-satisfaction-and-safety-100629963","NCT07481500","Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: A Randomized Trial of Pain, Procedure Time, Patient Satisfaction, and Safety","Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: A Randomized Controlled Trial Comparing Pain Perception, Procedure Duration, Patient Satisfaction, and Safety Between Eyelid Speculum and Cotton-Tipped Applicator Retraction Techniques","IVI-RETRACT","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Diagnosed with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or retinal vein occlusion (RVO)\n3. Scheduled for intravitreal anti-VEGF injection (bevacizumab, aflibercept, or faricimab)\n4. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Active ocular infection or inflammation\n2. Known allergy to povidone-iodine, tetracaine, or levofloxacin\n3. Inability to cooperate with the injection procedure\n4. Concurrent participation in another interventional clinical trial\n5. Anatomical eyelid abnormality precluding use of either retraction technique",{"count":299,"type":22},120,[125],"This randomized controlled trial compares two techniques for eyelid retraction during intravitreal injection (IVI) of anti-VEGF agents: the standard wire eyelid speculum (Group A) versus cotton-tipped applicator retraction (Group B) in patients with neovascular AMD, diabetic macular edema, or retinal vein occlusion.\n\nThe study evaluates four outcomes: (1) patient pain perception measured by a 10-cm visual analogue scale immediately after injection; (2) procedure duration from retraction device placement to removal; (3) patient satisfaction assessed by a 5-item Likert scale; and (4) safety including rates of subconjunctival hemorrhage, corneal abrasion, endophthalmitis, and intraocular pressure elevation.\n\nA novel syringe cap technique using the Terumo 31G insulin syringe plastic cap as an injection-site marker (3.5 mm for pseudophakic eyes, 5.0 mm for phakic eyes from the limbus) is employed in both groups, replacing the traditional caliper.\n\nRandomization is stratified by diagnosis and prior injection history using permuted block randomization (block sizes 4 and 6). The target sample size is 120 patients (60 per group) at Walailak University Hospital, Nakhon Si Thammarat, Thailand.",[303,28,304,305],"Neovascular Age-Related Macular Degeneration (nAMD)","Retinal Vein Occlusion","Intravitreal Injections",[307,308,309,310,311,312,313,314],"intravitreal injection","eyelid speculum","cotton-tipped applicator","injection pain","procedure time","patient satisfaction","anti-VEGF","randomized controlled trial","2026-03-13",{"date":317,"type":37},"2026-03-18",{"date":319,"type":22},"2026-06",{"date":321,"type":22},"2027-08",{"name":323,"class":146},"Jakkrit Juhong",{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":333,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":240},"100628163","phase-1-kamuvudine-9-k9-in-diabetic-macular-edema-100628163","NCT07458061","Kamuvudine-9 (K9) in Diabetic Macular Edema","Randomized Trial of Kamuvudine-9 (K9) in DME","K9","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy. Any one of the following will be considered sufficient evidence that diabetes is present:\n* Current regular use of insulin for the treatment of diabetes\n* Current regular use of oral hypoglycemic agents for the treatment of diabetes\n* DME based on investigator's clinical evaluation and evident on fundus photographs, fluorescein angiograms, or spectral domain-optical coherence tomography (SD-OCT)\n* HbA1c of ≤12% at screening.\n* BCVA of ≥ 24 and ≤ 68 letters (20\u002F50 or worse but at least 20\u002F320) by an ETDRS chart. BCVA of the non-study eye must be no worse than 20\u002F400 Snellen equivalent).\n* Mean central subfield thickness (CST) of at least 325 µm by SD-OCT.\n* Intraocular pressure of ≤ 21 mm Hg on 2 or fewer IOP lowering medications.\n* Capable of providing informed consent.\n* Capable and willing to follow study protocol.\n* Females of childbearing potential must agree to abstain from sex or use adequate method of contraception for the duration of the study period and for 28 days after the last dose of study drug.\n* Males must agree to abstain from sex or use adequate method of contraception for the duration of the study period and for 28 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Body weight \\\u003C 55 kg.\n* Macular edema considered to be due to causes other than diabetes.\n* Proliferative diabetic retinopathy or iris neovascularization (including the anterior chamber angle) in the study eye.\n* Inability to follow the study protocol, based on the investigator's assessment.\n* Females who are pregnant or breastfeeding.\n* Panretinal or scatter laser photocoagulation within 12 months of screening.\n* Topical steroid or topical NSAID in the study eye or oral NSAID treatment within 30 days of screening.\n* Active ocular inflammation of any history of intraocular inflammation within 1 year.\n* Prior intraocular or periocular treatment for DME including any of the following:\n\nIntravitreous injection of anti-VEGF therapies including but not limited to bevacizumab, ranibizumab, aflibercept, faricimab, and\u002For brolucizumab within 6 weeks of screening Intravitreous or sub-Tenon delivery of steroid therapy (e.g. triamcinolone, dexamethasone) within 12 months or fluocinolone acetonide implant within 3 years of screening.\n\n* Macular laser for the treatment of DME within 6 months of screening\n* Aphakia or total absence of the posterior capsule in the study eye.\n* Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye within 2 months of screening.\n* Any change in systemic steroid therapy within 3 months of screening.\n* Any ocular surgery in the study eye within 12 weeks of screening.\n* Presence of severe foveal ischemia in the study eye, defined as foveal avascular zone (FAZ) of \\>1.5 mm2 on OCT-Angiography (OCT-A) or fluorescein angiography (FA).\n* Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g. presumed ocular histoplasmosis, high myopia (spherical equivalent greater than 8 diopters), age-related macular degeneration) in the study eye.\n* History or presence of viral disease of the cornea or conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, any mycobacterial infections of the eye, or any fungal disease of any ocular structure or history of infectious retinitis in the study eye.\n* History or presence of any disease or condition that in the investigator's opinion would preclude study treatment or follow-up or that, in the opinion of the investigator, would render them as unlikely to benefit from study treatment.\n* History or presence of any other condition except for DME in the study eye that could affect interpretation of study assessments (e.g., but not limited to, geographic atrophy, macular hole, macular pucker, foveomacular traction, retinal vein occlusion, retinal degenerations), in the opinion of the investigator.\n* Any lens or corneal opacity in the study eye which impairs visualization of the posterior pole of the retina, in the opinion of the investigator.\n* History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator.\n* Taking any medications containing nucleotide reverse transcriptase inhibitors (NRTIs), including but not limited to Abacavir, Emtricitabine, Lamivudine, or Zidovudine; trade names Atripla, Biktarvy, Cimduo, Combivir, Complera, Delstrigo, Descovy, Dovato, Emtriva, Epivir, Epzicom, Genvoya, Odefsey, Retrovir, Stribild, Symfi, Symtuza, Triumeq, Trizivir, Truvada, Ziagen.\n* History of taking medications with known retinal toxicity (e.g., hydroxychloroquine, chloroquine, pentosan polysulfate sodium, and amiodarone).\n* Clinically significant unstable medical condition (other than diabetes) that would pose a risk to the participant, according to investigator's judgment (e.g., cardiovascular instability, systemic infection), or clinically significant laboratory abnormality.\n* Clinically significant abnormal liver or kidney function at screening. The following values \\[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m2\\] are exclusionary regardless of clinical symptoms.\n* Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.\n* Treatment with other investigational drug within 6 weeks or 5 half-lives of drug prior to screening, whichever is longer.\n* Participation in another clinical trial within 12 weeks before the screening visit or during the study (participation in clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary).\n* Plans to move away from study site within the next 2 months.",{"count":90,"type":22},[25,56],"The objectives of this investigation are to assess:\n\n1. whether oral K9 is safe in subjects with DME, and\n2. whether oral K9 improves BCVA compared to oral placebo",[28],"2026-03-06",{"date":338,"type":37},"2026-03-10",{"date":340,"type":22},"2026-02",{"date":342,"type":22},"2026-08",{"name":344,"class":146},"Dr. Bryan Strelow",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":357,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":4},"100628299","phase-2-study-of-cu06-1004-in-patients-with-daibetic-macular-edema-100628299","NCT07459829","Study of CU06-1004 in Patients With Daibetic Macular Edema","A Phase 2b, Randomized, Double-masked, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of CU06-1004 for 24 Weeks in Patients With Center-Involved Diabetic Macular Edema (DME)","Inclusion Criteria:\n\nPatients will be eligible for inclusion in the study if they meet all of the following criteria:\n\n1. Have read, understood, and signed the informed consent form.\n2. Patient is willing and able to comply with all study procedures, and is likely to complete the study, based on the investigator's judgment.\n3. Male and female patients must be ≥18 years of age at the time of screening visit. Race and ethnicity information will be collected based on National Institutes of Health criteria.\n4. Has a diagnosis of Type 1 or Type 2 diabetes mellitus.\n5. Has definite retinal thickening due to DME in the center of the macula of the study eye (either treatment-naïve or previously treated patients).\n6. The study eye has a BCVA of 25 to 69 (approximate Snellen equivalent of 20\u002F50 to 20\u002F320) at an initial distance of 4 meters, as assessed by the ETDRS letter score at screening.\n7. Has a study eye with CST of ≥320 µm for men or ≥305 µm for women as determined by Heidelberg Spectralis (or equivalent) SD-OCT (or Zeiss Cirrus OCT: 305 µm for men or 290 µm for women) and confirmed by the CRC at screening.\n8. Has a DRSS score of ≥43 confirmed by the CRC.\n9. Has media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.\n10. Is willing to abide by the contraceptive requirements.\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they meet any of the following criteria:\n\n1. Has only 1 functional eye, even if the eye met all other study requirements, or has and\u002For is likely to have amblyopia, amaurosis, or an ocular disorder with BCVA ≤25 ETDRS letter score (approximate Snellen equivalent of \\\u003C20\u002F320) in the fellow eye.\n2. Concurrent and\u002For history (where indicated) of an ocular condition including one or more of the following in the study eye:\n\n   1. Active proliferative diabetic retinopathy (PDR) or preretinal fibrosis involving the macula.\n\n      Note: Patients with mild PDR without high-risk features will be allowed in the study.\n   2. Vitreomacular traction or epiretinal membrane that is expected to affect central vision.\n   3. Iris neovascularization, vitreous hemorrhage, or tractional retinal detachment.\n   4. Uncontrolled glaucoma or filtration surgery for glaucoma in the past or likely to be needed in the future\n   5. Intraocular pressure (IOP) \\>24 mmHg at screening and randomization. IOP will be assessed by applanation tonometry (Goldmann tonometer, Tono-pen™, or an equivalent device).\n   6. Spherical equivalent of the refractive error of more than 6 diopters myopia or any signs of myopic chorioretinopathy.\n   7. Structural damage to the center of the macula that is likely to preclude improvement in BCVA following the resolution of macular edema, including atrophy of the RPE, subretinal fibrosis or scar, significant macular ischemia, or organized hard exudates.\n   8. Disease other than DME, that could compromise visual acuity, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause) as assessed by the investigator.\n   9. Macular edema is of nondiabetic retinopathy etiology (eg, secondary to vitreomacular interface abnormalities).\n   10. Inability to obtain fundus and OCT images due to, but not limited to, insufficient media clarity or inadequate pupil dilation.\n   11. Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred because of Yttrium-aluminum-garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation longer than 2 months before screening.\n3. Concurrent and\u002For history (where indicated) of ocular condition including one or more of the following in either eye:\n\n   1. There is evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis. However, a patient who has completely recovered from the infection at Week 1 (baseline) is allowed to be enrolled in the study at the investigator's discretion.\n   2. Has any active intraocular inflammatory disease such as uveitis or a history of intraocular inflammatory disease other than what would be expected in the normal postoperative course following prior routine ocular surgery such as cataract surgery.\n4. Had major surgery within 3 months prior to randomization or has major surgery planned during the next 6 months.\n5. Had unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening.\n6. Has the following illness or abnormal laboratory test values:\n\n   1. Persisting elevations of aspartate aminotransferase or alanine aminotransferase \\>2 × upper limit of normal (ULN)\n   2. Uncontrolled hypertension (systolic blood pressure of \\>180 mmHg or diastolic blood pressure of \\>100 mmHg).\n   3. Uncontrolled diabetes (hemoglobin A1c \\>12.0%).\n   4. Total bilirubin \\>1.5× upper limit of normal.\n   5. Positive results for HIV or hepatitis B or C viruses.\n   6. Other clinically significant abnormal laboratory values per the investigator's judgment.\n7. Has severe renal impairment, defined as an estimated glomerular filtration rate ≤ 30 mL\u002Fmin\u002F1.73 m².\n8. Has an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (eg, vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, or a nonretinal condition).\n9. Is expected to have no improvement of decreased visual acuity in the opinion of the investigator, even if macular edema is resolved (eg, foveal atrophy, abnormal pigmentation, dense subfoveal hard exudate).\n10. Have administered vaccinium myrtillus extract or calcium dobesilate within 2 weeks before randomization.\n11. Have a hypersensitivity to any excipients of the investigational product or similar class of drug and ingredient.\n12. A pregnant woman, lactating woman, or a female or male patient of childbearing potential who does not accept appropriate contraceptive measures for at least 6 months prior to the first dose of the study treatment (hormonal contraceptives, intrauterine contraceptive device, sterilization of spouse \\[eg, vasectomy, tubal ligation\\], double-barrier method \\[eg, combinational use of spermicides and condoms, diaphragm, contraceptive sponge, or FemCap\\], sexual abstinence).\n13. Has a medical condition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status including blood pressure, cardiovascular disease, and glycemic control or a significant medical condition including end-stage renal disease and severe liver diseases).\n\n    Patients with a study eye that meets any of the following criteria may not participate in this study:\n14. Has history of intravitreal (IVT) treatment with anti-VEGF agents prior to randomization: A 3-month washout for ranibizumab and bevacizumab, and a 4-month washout for aflibercept 2mg, (and 6 months for longer-acting agents such as faricimab or aflibercept 8mg) are required. Any patients with a history of prior brolucizumab use in the study eye will be excluded from this study.\n15. Has history of treatment with IVT or periocular triamcinolone acetonide or IVT dexamethasone within 12 months of screening or has received an IVT dexamethasone implant (Ozurdex), or fluocinolone acetonide implant (Iluvien) or Susvimo (ranibizumab) implant any time prior to randomization.\n16. Has history of panretinal scatter photocoagulation (PRP) or is anticipated to require PRP in the 3 months following randomization.\n17. Has history of focal laser treatment (focal\u002Fgrid laser photocoagulation) within 3 months prior to randomization and\u002For focal laser scar in the fovea that could limit BCVA improvement in the study eye.\n18. Has history of ocular surgery (including cataract extraction, any intraocular surgery, etc) within 3 months prior to screening or anticipated within the next 6 months following randomization.\n19. Has history of retinal detachment or retinal detachment repair surgery.\n20. Has history of vitrectomy.\n21. Participation in another interventional clinical trial for DME in either eye within 90 days before screening or any previous participation in a clinical trial of systemic antiangiogenic drugs with receipt of a previous study drug within 180 days before screening or 5 times the half-life of the study drug used, whichever is longer.",{"count":353,"type":22},156,[56],"This phase 2b trial is a randomized, double-masked, parallel-group, multi-center study in approximately 156 patients with DME to evaluate the efficacy and safety of CU06-1004 orally administered once daily for 24 weeks. The study will have a 1:1:1 randomization (CU06-1004 200mg: CU06-1004 300mg: Placebo).",[154,28,162],[28,154,358],"endothelial dysfunction blocker","2026-03-03",{"date":338,"type":37},{"date":362,"type":22},"2026-12-01",{"date":364,"type":22},"2028-01-30",{"name":366,"class":44},"Curacle Co., Ltd.",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":375,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":377,"conditions":378,"keywords":392,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":4},"100615866","wide-field-octa-in-ocular-diseases-100615866","NCT07298174","Wide Field OCTA in Ocular Diseases","Wide Field OCTA in Ocular Diseases: a Prospective Observational Study of the Clinical Impact of Wide Field OCTA in Ocular Disease.","WOOD-2025","Inclusion Criteria:\n\n* Age \\> 18 years\n* Both genders\n* Confirmed diagnosis of one of the above diseases\n* Age-related macular degeneration\n* Diabetic retinopathy\n* Myopia\n* Pachychoroid spectrum disease\n* Inherited retinal dystrophy\n* Uveitis\n* Dry eye\n* Visual acuity of at least 1\u002F20\n* Signed informed consent for the participation to the trial.\n\nExclusion Criteria:\n\n* Media opacities\n* Any other eye or systemic condition that may irreversibly impair the results of the study\n* Surgery in the eye in the study, including cataract extraction, in the three months prior to recruitment",true,{"count":250,"type":22},"The main retinal diseases, whether or not associated with specific mutations genetic, cause progressive degeneration of vascular retinal structures and not vascular, resulting in decreased visual function. Often, such diseases affect the noblest part of the retina, called macula. Many retinal diseases can be complicated by choroidal neovascularization which causes frequent bleeding and fluid leakage that accumulates in the subretinal and intraretinal spaces. Although the investigators know many details of each disease affecting the retina, very often the correct diagnostic framework can be complicated, given the presence of morphological elements common to the different pathologies. Similarly, predicting the effect of treatment and the patient's outcome is a constant challenge for the ophthalmologists. Most of the current research has been focused on the assessment of vascular alterations localized in the macula. However, growing evidence highlight the importance of peripheral vascular changes on the outcome of retinal diseases. These changes can be detected only be wide field OCT devices.\n\nOn the other hand, ocular inflammation and hyperemia represent major assessments in anterior segment disorders, such as dry eye disease. The current grading systems of ocular inflammation, redness and hyperemia are characterized by several limitations, thus making these evaluations still mainly confined to the subjective assessment performed by the ophthalmologist. However, the new generation OCT devices may include also an anterior segment module which can reconstruct anterior segment vessels, non-invasively, using the same technology described for retinal diseases.\n\nThe main goal of the study is to evaluate the diagnostic contribution of a new generation wide field OCTA device in ocular diseases, which has recently received CE marking. In particular, the investigators will evaluate this new generation device both in retinal and anterior segments diseases, testing for common points and differences with the standard of care non-invasive diagnostic devices. Secondary outcomes include the assessment of the correlation between the patient's visual function (visual acuity) and morphological changes (standard of care imaging assessment) highlighted by the wide field OCT device, with particular attention to microstructural differences between major ocular diseases and the possible development of non-invasive biomarkers, useful for the diagnosis and follow-up of such pathologies.",[379,28,29,380,381,382,383,384,385,386,387,388,389,390,391,304],"Age - Related Macular Degeneration (AMD)","Myopia","Inherited Retinal Disease","Stargardt Disease","Retinitis Pigmentosa (RP)","Best Disease","Geographic Atrophy","Macular Neovascularisation","Ocular Surface Disease","Central Serous Choroidopathy","Pachychoroid Disease","Uveitis","Vitreoretinal Disease",[393,394,395,396,397,398],"wide-field octa","multimodal retinal imaging","quantitative imaging","retinal disease","macular disease","ocular surface disease","2025-12-22",{"date":401,"type":37},"2025-12-30",{"date":403,"type":22},"2026-01",{"date":405,"type":22},"2028-05",{"name":407,"class":146},"IRCCS San Raffaele",{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":154,"eligibilityCriteria":414,"healthyVolunteers":375,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":433},"100500905","phase-1-phase-i-study-to-assess-the-safety-and-efficacy-of-ocu200-for-center-involved-diabetic-macular-edema-dme-100500905","NCT05802329","Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)","A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema","Inclusion Criteria:\n\n1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus\n2. Decreased visual acuity attributable primarily to DME\n3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:\n\n   1. ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis\n   2. ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus\n4. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart\n5. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging\n6. No history of prior anti-VEGF injection or history of at least 2 consecutive intravitreal anti-VEGF injection (less than 7 weeks apart) with incomplete resolution of CST within 1 year.\n\nNote: The last anti-VEGF injection must be administered at least six weeks (45 days) prior to the study treatment (Day 1) in the study eye.\n\nExclusion Criteria:\n\n1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)\n2. Uncontrolled hypertension\n3. Uncontrolled glaucoma\n4. Concurrent disease in the study eye, other than central-involved DME\n5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit\n6. Any ocular surgery within 3 months prior to the screening visit in the study eye\n7. Uncontrolled\u002Fpoorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)\n8. History of retinal detachment in the study eye or other retinal vascular disease in the study eye\n9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit\n10. Presence of any inherited retinal disease or history of proliferative diabetic retinopathy\n11. History of Renal disease including stage 3b or worse",{"count":416,"type":22},24,[25],"A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema",[420,28],"Center Involved Diabetic Macular Edema",[313,422,423,154],"Transferrin","Tumstatin","2025-11-25",{"date":426,"type":37},"2025-12-03",{"date":428,"type":37},"2024-01-13",{"date":430,"type":22},"2026-07-31",{"name":432,"class":44},"Ocugen",5,{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":446,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":4},"100613438","micropulse-laser-photocoagulation-in-diabetic-macular-edema-100613438","NCT07266597","Micropulse Laser Photocoagulation in Diabetic Macular Edema","Micropulse Laser Photocoagulation Treatment of Diabetic Macular Edema ; 5 % Versus 15 % Duty Cycle","Inclusion Criteria:\n\nPatients with diabetic retinopathy who:\n\n* Are More than 18 years old .\n* have diabetic macular edema with a central retinal thickness \\\u003C 400 um .\n* have best corrected visual acuity between 6\u002F18 and 6\u002F60 .\n\nExclusion Criteria:\n\n* Previous lasered retina , Anti - VEGF injection or vitrectomy .\n* Extensive Macular ischemia on FFA .\n* Media opacity .\n* Associated ocular pathology as glaucoma, CNV (choroidal neovascularization ) , AMD (age related macular degenerations ), epiretinal membrane vitreomacular traction and retinal vein occlusion .",{"count":442,"type":22},50,[125],"To assess the safety and efficacy of 532 nm subthreshold micropulse laser 5 % duty cycle compared with 15 % duty cycle in treatment of diabetic macular edema .",[28],[447],"micropulse , diabetic macular edema","2025-11-24",{"date":450,"type":37},"2025-12-05",{"date":452,"type":22},"2025-11-30",{"date":454,"type":22},"2027-02-01",{"name":456,"class":146},"Sohag University",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":476,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":488},"100591776","evaluation-of-serum--and-oct-biomarkers-in-patients-with-dme-treated-with-anti-vegf-or-dexamethasone-implant-100591776","NCT06984822","Evaluation of Serum- and OCT Biomarkers in Patients With DME Treated With Anti-VEGF or Dexamethasone Implant","Evaluation of Serum and Ocular Coherence Tomography Biomarkers in Patients With Diabetic Macular Edema Treated With Anti-VEGF or Dexamethasone Implant","BiomarkerOCT","Inclusion Criteria:\n\n* Type I or type II DM.\n* DME involving the center of the fovea with CFT more than 280 microns and the presence of intraretinal cysts.\n\nExclusion Criteria:\n\n* Prior history of any other macular disease.\n* Previous treatment with dexamethasone implants in the last six months for those in the anti-VEGF group.\n* Previous treatment with anti-VEGF in the last two months for those in the dexamethasone implant group.\n* Prior vitreoretinal surgery.\n* Previous laser treatment of the macula.\n* Previous panretinal photocoagulation.\n* Ocular surgery in the previous 3 months.",{"count":466,"type":22},150,[125],"This study aims to investigate the association between serum biomarkers and clinical response to anti-VEGF or dexamethasone implant by assessing OCT-biomarkers in patients with diabetic macular edema, DME, and to compare these with a group of naive patients (those not previously treated for DME).",[28,470,471,472,473,474,475],"Visual Impairment","Diabetes Mellitus","Hyperglycaemia (Diabetic)","Oxidative Stress","Vascular Endothelial Growth Factor","VEGF",[477],"optical coherence tomography","2025-11-17",{"date":480,"type":37},"2025-11-21",{"date":482,"type":37},"2025-08-01",{"date":484,"type":22},"2028-12-31",{"name":486,"class":487},"Vastra Gotaland Region","OTHER_GOV",2,{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":498,"briefSummary":499,"conditions":500,"keywords":505,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":240},"100558277","single-session-vs-multiple-session-panretinal-photocoagulation-for-treatment-of-proliferative-diabetic-retinopathy-100558277","NCT06549023","Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy","Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study","SMART-PRP","Inclusion Criteria:\n\n* Age \\> 18 years.\n* Patients with type 1 or type 2 Diabetes Mellitus with newly diagnosed Proliferative Diabetic Retinopathy, PDR.\n* Visual acuity ≥ 0.1 Snellen.\n* CRT of less than 300 micrometer measured by OCT without cysts in the neuroretina.\n* Clear media and adequately dilated pupil for PRP.\n\nExclusion Criteria:\n\n* Intraocular surgery within the last 4 months or planned within the next 3 months.\n* Previous or current center-involved diabetic macular edema (Ci-DME).\n* Previous PRP, intravitreal treatment (IVT), or macular laser treatment in study eye.\n* Treatment with medications known to risk macular edema.\n* Media opacity preventing adequate PRP.\n* General medical condition making office laser treatment very difficult or impossible.",{"count":5,"type":22},[125],"Proliferative diabetic retinopathy (PDR) is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR is panretinal photocoagulation (PRP). In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The purpose of this study is to compare the safety and effectiveness of single-session and multiple-session PRP.",[501,29,502,28,503,504],"Proliferative Diabetic Retinopathy","Diabetic Retinopathy Visually Threatening","Diabetes Mellitus, Type 1","Diabetes Mellitus, Type 2",[506,507,508,509,510,511,512,513,514,515,516,517,518],"Panretinal photocoagulation (PRP)","Single-session PRP","Multiple-session PRP","Navigated laser","Navilas","Central subfield retinal thickness (CRT)","Macular volume","Optical coherence tomography (OCT)","Swept-source optical coherence tomography (SS-OCT)","Wide-field fundus imaging","OCT-angiography","Retinal oximetry","Electroretinogram (ERG)",{"date":520,"type":37},"2025-11-18",{"date":522,"type":37},"2025-01-01",{"date":524,"type":22},"2030-12-31",{"name":486,"class":487},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":533,"maxAge":534,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":488},"100298179","phase-2-effect-of-levosulpiride-on-retinal-alterations-in-patients-with-diabetic-retinopathy-and-diabetic-macular-edema-100298179","NCT03161652","Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema","Clinical Trial to Evaluate the Safety and Efficacy of Levosulpiride to Improve Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema.","Inclusion Criteria:\n\n* Age equal or greater than 40 years but no older than 69 years\n* Male and female subjects with mild and moderate diabetic macular edema (DME), non-proliferative diabetic retinopathy (DR), and with proliferative DR undergoing medically prescribed vitrectomy.\n* Signing informed consent\n* Without ocular complications: severe myopia (\\> 6 diopters), ocular media opacity, retinal detachment, etc.\n* Without previous ocular treatments: ocular surgeries, retinal laser photocoagulation, intravitreal administration of antiangiogenic agents (delivered \\\u003C 6 months before enrollment).\n* Prolactin serum levels ≤ 20 ng\u002Fml\n* With normal or mild loss of kidney function (glomerular filtration rate \\>60 ml\u002Fmin) for groups with DME and DR without vitrectomy.\n* With mild to severe loss of kidney function (glomerular filtration rate \\>30 ml\u002Fmin) for groups with DR undergoing vitrectomy.\n* Without contraindications for the use of levosulpiride (Parkinson disease, epilepsy, breast cancer, alcoholism, hypokalemia).\n* Without hyperprolactinemia inducing conditions: Pathologies (hypothyrodism, hepatic dysfunction, prolactinomas); Medication (antipsychotics, antidepressants, prokinetics, other)\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria.\n* Adverse and intolerable drug effects.\n* Not complying with study medication\n* Inability to continue in-hospital appointments.\n* Missing outcome data\n* Hesitation to continue with study medication\n* Relocation to another state or country\n* Voluntary withdrawal of consent","40 Years","69 Years",{"count":299,"type":22},[56],"This is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of levosulpiride to improve retinal alterations due to diabetic macular edema and diabetic retinopathy",[28,29],[540,541,542,543,544,545,546],"diabetic retinopathy","blindness","eye","macular edema","prolactin","dopamine antagonists","peptide hormones",{"date":520,"type":37},{"date":549,"type":37},"2017-05-24",{"date":551,"type":22},"2027-06",{"name":553,"class":146},"Carmen Clapp",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":375,"sex":17,"minAge":18,"maxAge":561,"enrollmentInfo":562,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":4},"100610795","oct-based-screening-for-early-retinal-changes-in-asymptomatic-diabetic-patients-100610795","NCT07232225","OCT-Based Screening for Early Retinal Changes in Asymptomatic Diabetic Patients","DREAM-OCT","Inclusion Criteria:\n\n* Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 6 months\n* Best-corrected visual acuity (BCVA) of 6\u002F6 using Snellen chart\n* No visual symptoms (no blurred vision or metamorphopsia)\n* Clear ocular media allowing high-quality OCT imaging\n* No significant abnormalities on fundus examination\n* Intraocular pressure (IOP) below 21 mmHg\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* History of previous macular disease or treatment (laser photocoagulation or intravitreal injection)\n* Media opacity that prevents adequate OCT imaging (e.g., dense cataract, corneal opacity)\n* Presence of other retinal diseases (e.g., age-related macular degeneration, retinal vein occlusion)\n* Systemic or neurological diseases that affect the retina or visual pathway\n* Uncooperative participants or those who decline to give consent","75 Years",{"count":563,"type":22},112,"The goal of this observational study is to detect early retinal changes in people with diabetes who do not have visual symptoms. The study will use Optical Coherence Tomography (OCT) and fundus examination to screen for early retinal involvement in diabetic patients.\n\nThe main questions this study aims to answer are:\n\nCan OCT detect early retinal changes before symptoms appear in people with diabetes?\n\nIs fundus examination useful for identifying early diabetic retinal changes?\n\nParticipants will undergo a comprehensive eye examination, including OCT macular scans and fundus examination, at Assiut Ophthalmology Hospital. No treatment or invasive procedures will be performed as part of this study.\n\nThe collected data will help improve early detection and prevention of diabetic retinal complications.",[28],"2025-11-14",{"date":520,"type":37},{"date":569,"type":22},"2025-12-01",{"date":571,"type":22},"2027-01-01",{"name":573,"class":146},"Assiut University",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":23,"phases":583,"briefSummary":584,"conditions":585,"keywords":586,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":240},"100583865","phase-1-intranasal-delivery-of-octreotide-for-treatment-of-diabetic-macular-edema-100583865","NCT06881888","Intranasal Delivery of Octreotide for Treatment of Diabetic Macular Edema","Inclusion Criteria:\n\n1. Age range 18-90\n2. Clinical diagnosis of diabetic retinopathy with diabetic macular edema (defined as CST greater than 250 and presence of microglia\u002Fmacrophages on OCT) with a visual acuity between 20\u002F32 and 20\u002F200.\n3. Written informed consent is provided.\n4. Males and females\n5. Routine laboratory study results with bilirubin, aspartate aminotransferase and\u002For alanine aminotransferase, and creatinine within normal limits.\n\nExclusion Criteria:\n\n1. History of difficult to control diabetes or hypertension\n2. Eyes receiving laser photocoagulation in the last 6 months or intravitreous treatment for diabetic macular edema in the past 3 months.\n3. Eye having undergone YAG capsulotomy in the last 3 months.\n4. Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).\n5. All women of childbearing potential must have a negative urine pregnancy test at the Screening Visit and throughout the study. Sexually active women participating in the study must use a medically acceptable form of contraception.\n6. Chronic infectious disease (e.g. HIV, HCV)\n7. Positive urine β-hCG test day of visit or a serum beta-HCG test within 48 hours prior to the administration of intranasal octreotide.\n8. Other ocular diseases or fundus diseases\n9. Patients with a history of intolerance or hypersensitivity to octreotide or use of octreotide in the preceding 2 months.\n10. Currently taking an anti-inflammatory medication (e.g. anti-inflammatory agents, glucocorticoids or other immune modulating medications);\n11. Use of cyclooxygenase-2 (COX-2) inhibitors for \\\u003C 6 months prior to study entry or dose changes after study entry. Limited as-needed use is permitted prior to study entry but not during the study.\n12. Use of statins that cross the blood brain barrier such as atorvastatin will not be permitted during the study as they have been shown to reduce levels of pro-inflammatory cytokines.\n13. Any degree of hepatic or renal insufficiency that in the Investigator's judgement would pose a safety risk for treatment with octreotide.\n14. Patients who based on history or mental status examination have a significant risk of committing suicide, or who are homicidal or violent and who are in the Investigator's opinion in significant imminent risk of hurting others.\n15. Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.\n16. Patients with a current known infection or who are acutely ill.\n17. Patients with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis).\n18. Patients with thyroid disorders unless euthyroid at screening.\n19. Patients with cancer not in remission.\n20. Inability to tolerate or intranasal administration of investigated drug and experiences severe irritation or sneezing.\n21. Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study.\n22. Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures.\n23. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.\n24. Use of any investigational drug within 30 days prior to the baseline visit.","90 Years",{"count":582,"type":22},60,[25],"Treatment of diabetic retinopathy (DR) and diabetic macula edema has included panretinal photocoagulation and intra ocular injections of anti-vascular endothelial growth factors (anti-VEGF) agents and steroids. Anti-VEGF therapy is currently the first-line treatment for proliferative diabetic retinopathies; however, this approach is ineffective in more than 30% of patients with diabetic retinal complications. Available evidence shows that subcutaneous (under the skin) injection of octreotide, a somatostatin analog, has potential therapeutic benefits in proliferative diabetic retinopathy (PDR) and diabetic macula edema (DME). This study thus seeks to determine the efficacy and safety of intranasal DDM-octreotide in the treatment of diabetic macula edema in individuals that are considered to be refractory to the current therapeutic options.",[28],[28,587,588,29],"Intranasal Octreotide","Octreotide","2025-09-29",{"date":591,"type":37},"2025-10-03",{"date":593,"type":22},"2026-08-31",{"date":595,"type":22},"2027-12",{"name":597,"class":146},"University of Alabama at Birmingham",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":607,"briefSummary":608,"conditions":609,"keywords":613,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":624},"100376893","phase-1-ms-553-in-diabetic-retinopathy-patients-with-central-involved-macular-edema-100376893","NCT04187443","MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema","A Multicenter, Open-label, Dose Escalation Study Assessing the Safety and Treatment Effects of MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema","Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus (type 1 or type 2) according to ADA or WHO diabetic diagnosis criteria\n* Subject has the ability to follow the study instructions and is likely to complete all required study procedures and visits;\n* All males and females must consent to pregnancy prevention during the study and qualified measures of birth control. All females of childbearing potential must consent to a pregnancy test before entering the study.\n* Presence of central involved macular edema associated with diabetic retinopathy, i.e. diabetic macular edema (DME), as assessed by spectral domain optical coherence tomography (sd-OCT) of the central retina subfield thickness (CRT) at the Screening Visit (Centration must be confirmed by Investigators with signatures);\n* Best Corrected Visual Acuity (BCVA) score ≥ 34 letters (approximately 20\u002F200 to 20\u002F20 Snellen equivalent or better) using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol, and assessed at the Screening Visit Visual acuity (VA);\n* Confirmation by the investigator that laser photocoagulation and anti-VEGF treatments are either declined by the patients or not needed and can be withheld for at least 3 months after the Screening Visit;\n* Ocular media and pupil dilation adequate to permit good quality retinal imaging as assessed at Screening Visit.\n\nExclusion Criteria:\n\n* Subjects with unstable metabolic or blood pressure control\n* Subject with emaciation or obesity at Screening Visit: body mass index (BMI) \\\u003C18.5kg\u002Fm2 or \\>28kg\u002Fm2\n* Current use or likely need for medications know to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine \u002F hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol -\n* History of myocardial infarction or other cardiac event requiring hospitalization (unstable angina pectoris, etc.), cerebrovascular accident, transient ischemic attack, treatment for acute congestive heart failure or any arrhythmia within 4-months prior to Screening Visit;\n* Any situation that may in the opinion of the investigator preclude the safe administration of the study medication, adherence to the scheduled study visits, safe participation in the study or affect the results of the study as assessed at Screening Visit;",{"count":606,"type":22},45,[25],"This is an open label dose-escalation study to evaluate the safety and treatment benefits of MS-553 in treatment-naive diabetic retinopathy patients with central involved macular edema. Fifteen subjects with diabetic macular edema will be enrolled into each of three dose cohorts and will receive oral administration of MS-553 for 8 weeks.",[28,610,611,612,29],"Macular Edema","Type 2 Diabetes With Diabetic Macular Edema","Type 1 Diabetes With Diabetic Macular Edema",[28,610,614,615,154,29],"Center-involved Diabetic Macular Edema","Center-involved DME","2025-09-23",{"date":589,"type":37},{"date":619,"type":37},"2020-06-02",{"date":621,"type":22},"2026-12-30",{"name":623,"class":44},"Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.",3,{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":4,"overallStatus":205,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":642,"locationsCount":4},"100608301","phase-2-a-phase-2a-study-to-evaluate-the-safety-tolerability-and-efficacy-of-snp318-in-dme-patients-100608301","NCT07199777","A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patients","A Phase 2a, Randomized, Double-masked, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in Patients With Diabetic Macular Edema","Main Inclusion Criteria:\n\n1. Confirmed diabetes mellitus Type 1 or Type 2, with stable glycemic control\n2. Center-involved DME with CST \\>=320 µm (Study eye)\n3. BCVA between 82 and 25 letters, inclusive (Study eye)\n4. BCVA score ≥ 25 letters (Non-study eye)\n\nMain Exclusion Criteria:\n\n1\\. Use of the last intravitreal anti-VEGF injection in the study eye within 90 days prior to Screening",{"count":582,"type":22},[56],"The objective of this study is to assess the safety, efficacy, and tolerability of SNP318 in patients with DME.",[28,154],"2025-09-22",{"date":638,"type":37},"2025-09-30",{"date":640,"type":22},"2025-11",{"date":212,"type":22},{"name":643,"class":44},"SciNeuro",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":660,"leadSponsor":661,"locationsCount":240},"100595939","non-center-involving-diabetic-macular-edema-progression-in-early-postoperative-period-after-phacoemulsification-100595939","NCT07038967","Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification","Assessment of Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification","Inclusion Criteria:\n\n* Age ≥18 years.\n* Both sexes.\n* Patients with Grade I - Grade II nuclear cataract and non-center-involving diabetic macular edema (NCIDME).\n\nExclusion Criteria:\n\n* Traumatic cataract.\n* Severe Non-Proliferative\u002F Proliferative Diabetic Retinopathy.\n* Marked Asymmetry of retinopathy between both eyes.\n* Mature senile cataract or severe lens opacity.\n* Potentiality to have Phacotrabeculectomy surgery.\n* Complications during or after the surgery.",{"count":442,"type":22},"This study aims to evaluate the progression of non-center-involving diabetic macular edema in the early postoperative period following phacoemulsification.",[654,28,655],"Non-Center","Phacoemulsification","2025-06-29",{"date":658,"type":37},"2025-07-01",{"date":656,"type":37},{"date":569,"type":22},{"name":662,"class":146},"Ain Shams University"]