[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-macular-edema-dme\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-macular-edema-dme":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,41,72,87,114,126,154,177,200,222,248,281,311,338,366,393,413],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053830","phase-2-integrative-liver-targeted-therapy-for-diabetic-macular-edema-using-tauroursodeoxycholate-or-traditional-chinese-medicine-100053830",false,"NCT07457632","Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Using \"Tauroursodeoxycholate\" or Traditional Chinese Medicine.","Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.","Inclusion Criteria:\n\n1. Age range 18-89 years\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 CBC and Diff with bilirubin, aspartate aminotransferase and\u002For alanine aminotransferase, and creatinine within normal limits.\n\nExclusion Criteria:\n\n1. History of difficulty controlling diabetes or hypertension with changes in medication in the last 3 months.\n2. Eye having undergone YAG capsulotomy in the last 3 months.\n3. Having other ocular surgeries in the last 6 months (examples include but not limited to cataract surgery, scleral buckle, trabeculectomies, etc.).\n4. 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 if they are not trying to get pregnant.\n5. Chronic infectious disease (e.g. HIV, HCV)\n6. Positive urine β-hCG test day of visit or a serum-hCG test within 48 hours prior to the initiation of the study\n7. Other ocular diseases or fundus diseases\n8. Currently taking an anti-inflammatory medication (e.g. anti-inflammatory agents, glucocorticoids or other immune modulating medications);\n9. 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.\n10. 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.\n11. Any degree of hepatic or renal insufficiency that in the investigator's judgement would pose a safety risk with TUDCA or mQJDHW.\n12. Subjects 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.\n13. Subjects 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.\n14. Subjects with a current known infection or who are acutely ill.\n15. Subjects with an autoimmune disease (i.e., Lupus, Rheumatoid Arthritis).\n16. Subjects with thyroid disorders unless euthyroid at screening.\n17. Subjects with cancer not in remission.\n18. 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.\n19. Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures.\n20. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.\n21. Use of any investigational drug\u002F nutraceuticals within 30 days prior to the baseline visit.","ALL","18 Years","89 Years",{"count":20,"type":21},69,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Diabetic macular edema is seen in the later stages of diabetic retinopathy with current conventional therapies targeting local vascular dysfunction. These therapies provide transient improvement in vision and are often uncomfortable to persons with diabetic macular edema and financially burdensome. Diabetic macular edema, a complication of diabetes cannot be managed without addressing systemic inflammation. Liver metabolism and functions are implicated in diabetes and evidence suggests that hepatic metabolic dysfunctions are linked to the neuroinflammation and vascular dysfunctions observed in diabetic retinopathy. Nutraceutical supplements like Tauroursodeoxycholate (a bile acid) and modified Qi Ju Di Huang Wan (a traditional Chinese medicine formula) have been found to reduce hepatic and retinal oxidative stress, provide anti-apoptotic, anti-inflammatory, neuroprotective and hepatoprotective effects. This study will provide a non-invasive multi-targeted strategy for the management of diabetic macular edema.",[27],"Diabetic Macular Edema (DME)","NOT_YET_RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":21},"2026-10-01",{"date":36,"type":21},"2028-12-31",{"name":38,"class":39},"University of Alabama at Birmingham","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"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":50,"type":21},240,[52],"PHASE3","This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.",[55,47,27],"Diabetic Macular Edema",[57,58,59,55],"EyePoint","EYP-1901","Tyrosine Kinase Inhibitor","RECRUITING","2026-06-01",{"date":63,"type":32},"2026-06-03",{"date":65,"type":32},"2026-02-16",{"date":67,"type":21},"2028-10",{"name":69,"class":70},"EyePoint Pharmaceuticals, Inc.","INDUSTRY",65,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":53,"conditions":79,"keywords":80,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":85,"locationsCount":86},"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":50,"type":21},[52],[55,47,27],[57,59,55,58],{"date":63,"type":32},{"date":83,"type":32},"2026-02-09",{"date":67,"type":21},{"name":69,"class":70},62,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":40},"100637263","phase-4-zhuochuming-3te-dme-study-treatment-nave-patients-100637263","NCT07612904","Zhuochuming®-3T&E-DME Study (Treatment-naïve Patients)","A Prospective, Randomized Controlled, Open-label, Multicenter Clinical Trial of the Efficacy and Safety of Aflibercept Intravitreal Injection (Zhuochuming®) With a 3-month Loading Phase Followed by Treat-and-extend Regimen in Treatment-naïve Patients With Diabetic Macular Edema","Inclusion Criteria:\n\n1. Subject voluntarily participates in the study and signs the informed consent form.\n2. Subject is aged ≥18 years and has a diagnosis of type 1 or type 2 diabetes mellitus.\n3. Refractive status and axial length of the study eye: -6.00D \\\u003C spherical equivalent \\\u003C +6.00D, or 21 mm \\\u003C axial length \\\u003C 26 mm.\n4. Best-corrected visual acuity (BCVA) of the study eye at screening and baseline is between 78 and 24 ETDRS letters (approximately equivalent to Snellen 20\u002F32 to 20\u002F320).\n5. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose and must use an acceptable method of contraception.\n6. Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.\n7. The study eye has center-involving diabetic macular edema (DME), defined as central retinal thickness (CRT) ≥300 μm (or ≥320 μm assessed by Heidelberg Spectralis) confirmed by the reading center of the Third People's Hospital of Dalian (primary center) at baseline visit. The reading center is composed of three senior vitreoretinal specialists and experts from the functional examination department of the Third People's Hospital of Dalian.\n8. Visual impairment is primarily caused by DME.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the study drug.\n2. Prior intraocular surgery in the study eye, including macular laser photocoagulation, panretinal photocoagulation, etc.\n3. Prior intraocular or periocular steroid treatment in the study eye.\n4. Prior intravitreal anti-VEGF therapy (e.g., ranibizumab, conbercept, bevacizumab) in the study eye.\n5. Prior photodynamic therapy in the study eye.\n6. Active ocular inflammation (including trace or more) in either eye.\n7. Aphakia or absence of the posterior capsule in the study eye (excluding pseudophakic eyes).\n8. History of corneal transplantation in the study eye.\n9. History of idiopathic or autoimmune uveitis in either eye.\n10. Uncontrolled glaucoma in the study eye (defined as intraocular pressure \\>25 mmHg despite anti-glaucoma medication) or history of glaucoma filtering surgery.\n11. Any history of vitreous hemorrhage in the study eye within 4 weeks prior to screening.\n12. Presence of other retinal diseases in the study eye, such as retinal detachment, retinal vein occlusion, etc.\n13. Inadequately controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg based on average of ≥2 measurements), allowing improvement with antihypertensive treatment; or history of hypertensive crisis or hypertensive encephalopathy.\n14. Severe cardiovascular disease (myocardial infarction or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months prior to the first dose.\n15. Renal failure requiring dialysis or kidney transplantation.\n16. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n17. History of schizophrenia or substance abuse (psychoactive drugs).\n18. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.\n19. Glycated hemoglobin (HbA1c) level ≥10%, and\u002For recent signs of uncontrolled diabetes (≥3 episodes of severe hypoglycemia within 3 months before baseline, or hospitalization due to acute hyperglycemia-related complications such as diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), or other emergencies caused by severe hyperglycemia (e.g., dehydration, electrolyte disturbance, altered consciousness); or ≥2 episodes of DKA within 1 year before baseline, or ≥1 episode of DKA within 3 months before baseline).\n20. Presence of proliferative diabetic retinopathy (PDR) in the study eye.\n21. Ocular disease in the study eye that may confound interpretation of study results, including choroidal neovascularization (CNV) of any cause (e.g., age-related macular degeneration, ocular histoplasmosis, or pathologic myopia).\n22. Cataract in the study eye that causes visual impairment, or patients judged by the investigator as likely to undergo cataract surgery during the study period.\n23. The study eye is aphakic (post-vitrectomy), silicone oil-filled, or gas-filled.\n24. Best-corrected visual acuity (BCVA) of the non-study eye \\\u003C19 ETDRS letters (approximately equivalent to Snellen 20\u002F400) at screening and baseline.\n25. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.",{"count":95,"type":21},186,[97],"PHASE4","The goal of this clinical trial is to understand whether Zhuochuming® (Aflibercept Intravitreal Injection) using a 3 loading doses followed by a treat-and-extend regimen (3+T\\&E) can treat patients with diabetic macular edema (DME) who have not received prior treatment. It will also evaluate the safety of Zhuochuming®.\n\nThe main questions it aims to answer are:\n\nCan Zhuochuming® using the 3+T\\&E regimen improve patients' vision better than the traditional pro re nata (3+PRN) regimen?\n\nHow much can the macular edema (central retinal thickness) be reduced?\n\nWhat medical problems (ocular or systemic) will participants experience while taking Zhuochuming®?\n\nWhat is the difference in the number of injections needed over one year between the two regimens?\n\nResearchers will directly compare Zhuochuming® (3+T\\&E regimen) with Zhuochuming® (3+PRN regimen) to see which regimen is more effective and convenient for treating DME.\n\nParticipants will:\n\nReceive treatment and be followed for 52 weeks (about 1 year)\n\nFirst receive 3 injections (one every 4 weeks), and then continue according to their assigned group:\n\nT\\&E group: Injection intervals are gradually extended (up to 16 weeks) based on disease stability\n\nPRN group: Follow-up visits every 4 weeks, with injections given only when needed\n\nVisit the clinic at scheduled times (e.g., before each injection or every 4 weeks) for eye examinations (visual acuity, intraocular pressure, OCT, etc.)\n\nUndergo regular blood tests (complete blood count, liver function, coagulation function, HbA1c, etc.)\n\nRecord any discomfort or side effects and report them to the doctor\n\nStudy population:\n\nPatients with diabetic macular edema (DME) who have not received prior treatment, aged ≥18 years, and diagnosed with type 1 or type 2 diabetes.\n\nPrimary study endpoint:\n\nChange in best-corrected visual acuity (BCVA) from baseline at week 52.",[27],[101,102,103,104],"Prospective","randomized controlled","open-label","multicenter","2026-05-21",{"date":107,"type":32},"2026-05-29",{"date":109,"type":21},"2026-06-30",{"date":111,"type":21},"2028-07-31",{"name":113,"class":39},"The Third Peoples Hospital of Dalian",{"id":115,"slug":4,"hasResults":11,"nctId":12,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":25,"conditions":118,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":125,"locationsCount":40},"100628130",{"count":20,"type":21},[24],[27],"2026-04-03",{"date":121,"type":32},"2026-04-09",{"date":123,"type":21},"2026-07-01",{"date":36,"type":21},{"name":38,"class":39},{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":40},"100632927","biomarkers-in-diabetic-retinopathy-treated-with-faricimab-vs-biosimilar-ranibizumab-100632927","NCT07520045","Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab","A Comparative Analysis of OCT and OCT Angiography Biomarkers and Systemic Laboratory Parameters in Patients With Diabetic Retinopathy Undergoing Treatment With Faricimab or Biosimilar Ranibizumab Following Three Loading Doses","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Diabetic retinopathy with or without central macular edema\n* Indication for intravitreal anti-VEGF therapy according to current clinical guidelines\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Intravitreal anti-VEGF or corticosteroid treatment in the study eye within 5 months prior to enrollment\n* Any intraocular surgery (including cataract surgery) 3 months prior intraocular surgery to enrollment\n* Retinal laser photocoagulation in the study eye within 3 months prior to enrollment\n* Presence of other ocular, retinal or macular diseases that may affect OCT\u002FOCTA findings or visual acuity (e.g., age-related macular degeneration, retinal vascular occlusions)\n* Retinal detachment, preretinal fibrosis, vitreomacular traction\n* Significant media opacities (e.g., dense cataract, vitreous hemorrhage) precluding reliable OCT\u002FOCTA imaging\n* Uncontrolled glaucoma (intraocular pressure \\> 30 mmHg in study eye)\n* Active ocular inflammation\n* Suspected active ocular infection in either eye\n* Any febrile illness within 1 week prior to first injection\n* History or presence of any clinically significant disease, non-diabetic metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the opinion of the investigator, may contraindicate treatment with faricimab or biosimilar ranibizumab, interfere with the interpretation of study results, or place the participant at increased risk of treatment-related complications.\n* Women who are pregnant, breastfeeding, or planning pregnancy within the next 100 weeks\n* Known hypersensitivity to faricimab or biosimilar ranibizumab or any of its excipients\n* Participation in another clinical trial that may affect study outcomes\n* Inability to comply with study procedures or follow-up",{"count":134,"type":21},100,[136],"NA","The goal of this clinical trial is to see if treatment with faricimab or biosimilar ranibizumab leads to different early imaging changes in adults with diabetic retinopathy requiring anti-VEGF treatment and to identify OCT and OCTA biomarkers predictive of differential early treatment response between the two therapies. The main questions it aims to answer are:\n\nWhich OCT and OCT angiography biomarkers predict early treatment response? How do imaging biomarkers change after three loading doses of treatment? Are imaging biomarkers associated with systemic laboratory parameters? Researchers will compare faricimab to biosimilar ranibizumab to see if there are differences in imaging biomarkers and early treatment response.\n\nParticipants will:\n\n* be randomized in a 1:1 ratio using a computer-generated randomization sequence\n* undergo comprehensive ophthalmic examinations, including visual acuity and intraocular pressure measurement\n* undergo OCT and OCT angiography imaging at each visit\n* receive three intravitreal injections during the loading phase\n* attend follow-up visits from baseline to 4-5 weeks after the third injection\n* provide blood samples for systemic laboratory analysis",[139,27],"Diabetic Retinopathy (DR)",[141,142,143,144,145],"Diabetic Retinopathy","ranibizumab","faricimab","biomarkers","OCT","2026-04-02",{"date":121,"type":32},{"date":149,"type":32},"2026-03-12",{"date":151,"type":21},"2027-06-01",{"name":153,"class":39},"Osijek University Hospital",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100632545","phase-3-efficacy-evaluation-study-of-bat5906-and-lucentis-in-patients-with-diabetic-macular-edema-100632545","NCT07515079","Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema","A Multicenter, Randomized, Double-Blind Phase III Clinical Study Comparing the Efficacy and Safety of BAT5906 Versus Ranibizumab (Lucentis®) in Patients With Diabetic Macular Edema (DME)","Inclusion Criteria:\n\n* All of the following criteria must be met for inclusion:\n\n  1. Voluntarily signed informed consent form, willing and able to comply with outpatient visits and study procedures as scheduled by the trial.\n  2. Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years (including boundary values).\n  3. Diabetic macular edema (DME) with OCT findings demonstrating involvement of the macular center (fovea or paracentral fovea) in the study eye. (fovea or parafovea);\n  4. Central retinal thickness (CRT) of the study eye \\>300 μm (or \\>320 μm for Heidelberg OCT) as assessed by central image review during screening;\n  5. Best-corrected visual acuity (BCVA) of the study eye between 73 and 21 letters (using ETDRS chart, including boundary values; equivalent to Snellen visual acuity scores of 20\u002F40 to 20\u002F400);\n  6. Contralateral eye BCVA \\> 24 letters (using ETDRS chart, equivalent to Snellen acuity 20\u002F320); Note: If both eyes meet inclusion criteria, the eye with poorer BCVA is selected as the study eye, unless the investigator determines the other eye is more suitable.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded from this study:\n\n  1. Presence of structural damage in the central macula of the study eye that may prevent improvement in best-corrected visual acuity after resolution of macular edema, including retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia (as indicated by marked disruption of the arcade pattern on fluorescein angiography), or histochemical sclerosing exudates. 2. Vitreomacular traction or epimacular membrane deemed by the investigator to significantly impair visual improvement;\n  2. Presence of any condition in the study eye other than diabetic macular edema that may confound fundus evaluation or visual acuity testing (e.g., retinal vascular occlusion, retinal detachment, optic nerve ischemia, vitreomacular traction, macular hole, pre-retinal fibrosis involving the macula, choroidal neovascularization, age-related macular degeneration);\n  3. Aphakia in the study eye or presence of an intraocular lens with posterior capsule opacification (exemption granted for posterior capsule opacification resulting from YAG capsulotomy, provided a 1-month washout period is met);\n  4. The study eye has uncontrolled glaucoma (intraocular pressure \\>25 mmHg despite antiglaucoma medication); or a history of glaucoma filtration surgery; or plans for antiglaucoma surgery during the study period;\n  5. The study eye has undergone vitreoretinal surgery or scleral buckling;\n  6. The study eye has undergone panretinal photocoagulation (PRP) or focal\u002Fgrid PRP in the macular area within the preceding 3 months, or there is a possibility of undergoing PRP during the study period;\n  7. Presence of neovascular glaucoma, iris neovascularization, or other clinically significant iris lesions deemed abnormal by the investigator in the study eye;\n  8. Active proliferative diabetic retinopathy (PDR) in the study eye, characterized by fibrovascular proliferation, vitreous hemorrhage, and retinal detachment;\n  9. The study eye has undergone intraocular surgery within the past 3 months, or is scheduled to undergo intraocular surgery during the study period;\n  10. The study eye has refractive media opacities (e.g., corneal scarring, undilatable pupils, cataracts, vitreous hemorrhage) that interfere with visual acuity assessment or fundus examination;\n  11. The study eye has received intravitreal injection of long-acting or sustained-release corticosteroids (e.g., dexamethasone intravitreal implant) or high-dose oral corticosteroids (\\>10 mg prednisolone or equivalent daily dose) within 6 months prior to baseline, except for patients using inhaled, intranasal, or low-dose topical corticosteroids applied to the skin; the study eye had received intravitreal injections of short- or medium-acting corticosteroids (e.g., triamcinolone) within 3 months prior to baseline; Periorbital corticosteroid injections administered to the study eye within 1 month prior to baseline; Fluocortolone intravitreal implants used in the study eye at any time prior to baseline; Systemic corticosteroid therapy received within 5 days prior to baseline;\n  12. The equivalent spherical refractive error of the study eye exceeds -6.0 diopters. For patients with a history of refractive or cataract surgery, the refractive error of the study eye should not exceed -6.0 diopters preoperatively. If preoperative refractive results are unavailable, the measured axial length must not exceed 26mm;\n  13. History of uveitis in either eye;\n  14. Active ocular inflammation or infection (bacterial, viral, parasitic, or fungal) in either eye;\n  15. Receipt of anti-VEGF therapy in the study eye or systemic administration within 90 days (inclusive) prior to randomization;\n\n      Exclusion Criteria for Abnormal Laboratory Findings:\n  16. Abnormal liver or renal function (defined in this trial as ALT and AST not exceeding 2.5 times the upper limit of normal for this center's laboratory; Crea and BUN not exceeding 2 times the upper limit of normal for this center's laboratory);\n  17. Coagulation abnormalities (prothrombin time \\> 3 seconds above the upper limit of normal, activated partial thromboplastin time \\> 10 seconds above the upper limit of normal);\n  18. Patients with any active infection: positive hepatitis B screening (defined as positive hepatitis B surface antigen and HBV-DNA \\> 1000 IU\u002FmL or the hospital's maximum cutoff value), Positive screening for hepatitis C (defined as positive HCV antibodies and positive HCV-RNA), positive human immunodeficiency virus (HIV) antibodies, positive screening for Treponema pallidum antibodies (Anti-TP) (positive specific antibody test, negative non-specific antibody test, except for those clinically assessed as non-active infection).\n\n      Other exclusion criteria:\n  19. Acute cardiovascular or cerebrovascular disease, related treatment, or other thromboembolic disorders within 6 months prior to first dosing;\n  20. Poorly controlled diabetes or glycated hemoglobin (HbA1c) \\>11%;\n  21. Uncontrolled hypertension (defined as blood pressure \\>160\u002F95 mmHg despite antihypertensive medication);\n  22. Undergone surgery within the past month with unhealed wounds, or as determined by the investigator;\n  23. Diagnosed systemic autoimmune disease (e.g., ankylosing spondylitis, systemic lupus erythematosus) or any uncontrolled clinical condition (e.g., malignancy, active hepatitis, severe psychiatric, neurological, cardiovascular, respiratory disorders);\n  24. History of conditions contraindicated for the study drug, metabolic dysfunction, physical examination findings, or diseases\u002Fsymptoms reasonably suspected based on clinical laboratory results that are contraindications for the study drug, may affect study outcome assessment, or expose the subject to a higher risk of complications;\n  25. Known allergy or contraindication to the study drug or its components, fluorescein, povidone-iodine, or indocyanine green;\n  26. Participation in any drug clinical trial (excluding vitamins and minerals) within 90 days prior to the first study dose (calculated from the last dose of the investigational drug; if the investigational drug has a long half-life, the period shall be 5 half-lives if \\>3 months);\n  27. Pregnant, pregnant women, or lactating women (pregnancy defined in this trial as a positive blood\u002Furine pregnancy test); Male or female subjects of reproductive potential who refuse to use appropriate contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study period and for 3 months after the last visit. Women defined as reproductive potential include those who have not yet reached menopause, or who have reached menopause but have not maintained a continuous menopausal state for \\>12 months, and who have not undergone sterilization (ovariectomy and\u002For hysterectomy). The definition of fertility may be adjusted according to local standards in each region.\n\n      Note: Highly effective contraceptive methods include complete abstinence, intrauterine devices, dual barrier methods (e.g., condom + spermicide-containing diaphragm), contraceptive implants, hormonal contraceptives \\[oral contraceptives, contraceptive implants, transdermal patches, hormonal vaginal devices, or depot injections\\], or a partner who has undergone vasectomy with confirmed azoospermia.\n  28. Other conditions deemed by the investigator to warrant exclusion.","80 Years",{"count":163,"type":21},406,[52],"A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment. After screening, eligible subjects were randomized in a 1:1 ratio to the treatment group or the control group. The treatment group received BAT5906 injection, while the control group received Lucentis®. During the trial, ophthalmic examinations and safety assessments were conducted according to the protocol for efficacy and safety evaluation. Blood samples were collected for immunogenicity assessment. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in the study eye from baseline to week 52 (measured using the ETDRS chart).",[27],"2026-03-30",{"date":169,"type":32},"2026-04-07",{"date":171,"type":32},"2024-10-09",{"date":173,"type":21},"2027-04-30",{"name":175,"class":70},"Bio-Thera Solutions",50,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100620846","early-phase-1-safety-and-efficacy-evaluation-of-lx111-gene-therapy-in-dme-patients-100620846","NCT07362927","Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients","An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Diabetic Macular Edema (DME)","Inclusion Criteria:\n\n1. Willing to sign the informed consent, and willing to attend follow-up visits;\n2. Age ≥ 18;\n3. Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea;\n4. CST ≥ 300 μm in the study eye at Screening;\n5. BCVA ETDRS letters between 19 and 73;\n6. Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response;\n7. Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.\n\nExclusion Criteria:\n\n1. Active proliferative diabetic retinopathy (PDR);\n2. Presence of iris neovascularization in the study eye at Screening;\n3. Retinal laser photocoagulation in the study eye within 3 months prior to Screening;\n4. Prior gene therapy in the study eye;\n5. The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening.\n6. Systemic anti-VEGF treatment within 3 months before Screening;\n7. Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to Screening;",{"count":185,"type":21},32,[187],"EARLY_PHASE1","The goal of this study is to evaluate the safety and efficacy of LX111 treatment of DME. This study will enroll participants aged ≥ 18 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.",[27],"2026-03-09",{"date":192,"type":32},"2026-03-10",{"date":194,"type":21},"2026-03",{"date":196,"type":21},"2031-09",{"name":198,"class":39},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",2,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"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":208,"type":21},156,[24],"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).",[47,55,27],[55,47,213],"endothelial dysfunction blocker","2026-03-03",{"date":192,"type":32},{"date":217,"type":21},"2026-12-01",{"date":219,"type":21},"2028-01-30",{"name":221,"class":70},"Curacle Co., Ltd.",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":4},"100626629","phase-4-efficacy-comparison-of-dexamethasone-intravitreal-implant-combined-with-aflibercept-versus-aflibercept-monotherapy-in-treatment-nave-inflammatory-diabetic-macular-edema-patients-100626629","NCT07438119","Efficacy Comparison of DExamethasone Intravitreal Implant Combined With Aflibercept Versus Aflibercept Monotherapy in Treatment-naïve Inflammatory Diabetic Macular Edema Patients","Efficacy Comparison of DExamethasone Intravitreal Implant Combined With Aflibercept Versus Aflibercept Monotherapy in Treatment-naïve Inflammatory Diabetic Macular Edema Patients (DECADE Study)","DECADE","Inclusion Criteria:\n\nAll of the following conditions must be met simultaneously:\n\n1. Age ≥ 18 years, diagnosis of diabetes mellitus (type Ⅰor type Ⅱ).\n2. With good glycaemic control and glycated haemoglobin ≤10.0%.\n3. DR stage II-IV.\n4. Treatment with aflibercept intravitreal injection is planned for center-involved diabetic macular edema (CI-DME) , Central macular thickness (CMT) ≥300 μm in the 1-mm-diameter zone around fovea with best corrected visual acuity(BCVA) \\\u003C20\u002F25.\n5. Presence on OCT imaging of one or more of the following findings in the study eye(within 1000-μm-diameter of the center of the fovea): central macular thickness (CMT) ≥500μm, foveal intraretinal cystoid spaces ≥300μm in height or ≥250μm in width(large IRC), serous retinal detachment (SRD), Intraretinal hyperreflective dots (HRDs), Hard exudates (HEs).\n6. No refractive interstitial clouding and pupillary constriction affecting fundus examination.\n\nExclusion Criteria:\n\n1. Grade III and IV cataracts, or those with post-comorbid subcapsular cataracts,\n2. Other macular degeneration such as Macular epiretinal membrane and Macular Hole, etc., or macular edema caused by other causes such as uveitis, retinal vein occlusion, etc.,\n3. Combined with diabetic optic neuropathy,\n4. Any prior use of an approved or investigational treatment for DME in the study eye such as anti-VEGF drugs or corticosteroids drugs etc.,\n5. History of vitreoretinal surgery and\u002For including scleral buckling in the study eye,\n6. Transscleral fixated IOLs and ruptured posterior lens capsule,\n7. Active or suspected ocular and periocular infections,\n8. Advanced glaucoma or uncontrolled glaucoma with anti-glaucoma drugs; Or a history of glucocorticoid-induced elevated intraocular pressure,\n9. Systemic conditions such as asthma, severe hypertension, cerebrovascular accident or myocardial infarction, or other reasons for not being able to co-operate with the relevant examination,\n10. Pregnant or lactating,\n11. Patients with hypersensitivity to dexamethasone or to any other components of the product,\n12. Patients are allergic to aflibercept or any of the ingredients Aflibercept Intravitreous Injection.",{"count":231,"type":21},114,[97],"This is a 12-month, prospective, randomized controlled, multi-center, open-label, superiority designed study. Treatment-Naïve DME patient with inflammatory biomarkers, who meet the inclusion and exclusion criteria, will be recruited.\n\nThis study aims to provide the first direct comparative evidence within a Chinese cohort, evaluating the efficacy and safety of a combined DEX-I plus aflibercept therapy versus aflibercept monotherapy for DME. The investigation will focus on functional visual outcomes, anatomical improvements, and the respective safety profiles associated with each treatment regimen. Furthermore, the study will incorporate specific optical coherence tomography (OCT) biomarkers to refine patient selection, with the goal of enhancing the precision of identifying candidates for combination therapy.\n\nIt is hypothesized that the combination therapy, by concurrently targeting both VEGF-mediated and inflammatory pathways, may yield superior clinical outcomes compared to monotherapy.",[27],[47,236,237,238],"aflibercept","dexamethasone implant","Biomarker","2026-02-26",{"date":241,"type":32},"2026-02-27",{"date":243,"type":21},"2026-03-15",{"date":245,"type":21},"2028-03-15",{"name":247,"class":39},"Kun Liu",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":255,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":264,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":199},"100616143","phase-4-comparing-single-versus-multiple-anti-vegf-injections-in-diabetic-patients-undergoing-cataract-surgery-100616143","NCT07301775","Comparing Single Versus Multiple Anti-VEGF Injections in Diabetic Patients Undergoing Cataract Surgery","A Randomised Controlled Trial Comparing Efficacy of Single Versus Multiple Intravitreal Anti-VEGF Injections to Prevent Diabetic Retinopathy Progression in Patients Undergoing Cataract Surgery","Inclusion Criteria:\n\n* diabetic patients of both sexes ≥ 40 years of age presenting with non-proliferative diabetic retinopathy and cataract\n\nExclusion Criteria:\n\n* presence of proliferative diabetic retinopathy (PDR), diabetic macular oedema involving foveal centre, history of intraocular surgery or laser photocoagulation or prior anti-VEGF injection therapy in the study eye within past six months, history of intraocular inflammation (uveitis), glaucoma, mature cataract preventing satisfactory fundus examination preoperatively, poor glycaemic control (HbA1c\\>9%), pregnant and lactating women, known allergy to aflibercept (anti-VEGF used) and systemic thromboembolic events (stroke, myocardial infarction) within the last three months.","40 Years",{"count":257,"type":21},166,[97],"Objective of this randomised controlled trial is to compare the efficacy of a single per operative anti VEGF injection with repeated postoperative anti VEGF injections in the prevention of diabetic retinopathy progression after cataract surgery.\n\nThis Randomised Controlled Trial (RCT) will be conducted at Sahiwal Teaching Hospital and University College of Medicine \\& Dentistry Lahore. Duration of study will be from January 2026 to September 2026. This study will be single blind and parallel group research.\n\nThe study will include diabetic patients of both sexes ≥ 40 years of age presenting with non-proliferative diabetic retinopathy and cataract.\n\nExclusion criteria include proliferative diabetic retinopathy, center-involving diabetic macular oedema (DME), poor glycemic control (HbA1c \\>9%), glaucoma, uveitis, prior ocular surgery or laser, and recent systemic thromboembolic events.\n\nSubjects will be randomly divided into two groups, each containing 83 subjects. Standard phacoemulsification with intraocular lens implantation will be performed in all participants.\n\nA single intra vitreal Aflibercept injection ( 2mg\u002F0.05 ml ), will be given to group 1 participants. While, group 2 participants will receive an intra operative injection plus two additional injections at 1 month and 2 months postoperatively.\n\nFor all participants, follow up will be performed at 1 week, 1 month, 2 month, 3 month and 6 month.\n\nPrimary Outcome include progression of diabetic retinopathy (DR) severity (≥1 stage according to the guidelines of the international clinical diabetic retinopathy disease severity scale ICDR) or onset\u002Fprogression of DME.\n\nSecondary Outcomes include changes in best corrected visual acuity, changes in central macular thickness (CMT), and need for rescue treatment.\n\nSPSS version 26 will be utilised to analyse the data. P ≤ 0.05 will be taken as statistically significant. Qualitative variable like diabetic retinopathy grading and diabetic macular oedema status will be analysed by utilising Pearson's chi-square test. Quantitative variables like central macular thickness will be analysed by employing t-test.",[139,27,261,262,263],"Cataract","Phacoemulfisication+IOL Implantation","Intravitreal Injection",[265,266,267,263,268,269,270,271],"Vascular endothelial growth factor","Aflibercept","Cataract Extraction","Phacoemulsification","Diabetic retinopathy","Diabetic macular edema","Intraocular lens implantation","2025-12-10",{"date":274,"type":32},"2025-12-24",{"date":276,"type":21},"2026-01-01",{"date":278,"type":21},"2026-09-30",{"name":280,"class":39},"Ahmad Zeeshan Jamil",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":287,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":293,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":307,"leadSponsor":309,"locationsCount":40},"100567039","phase-4-high-dose-aflibercept-in-diabetic-macular-edema-in-patients-with-previous-vitrectomy-100567039","NCT06662994","High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy","Inclusion Criteria:\n\n* A patient must meet the following criteria at both the screening and randomization visits (except where indicated) to be eligible for inclusion in the study:\n\n  1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus\n  2. DME with central involvement in the study eye with CRT ≥320 μm on Spectralis.\n  3. BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 84 to 20 (approximate Snellen equivalent of 20\u002F25 to 20\u002F400) in the study eye with decreased vision determined to be primarily the result of DME\n  4. Willing and able to comply with clinic visits and study-related procedures\n  5. Provide informed consent signed by study patient or legally acceptable representative\n  6. Have a previous history of vitrectomy surgery.\n\nExclusion Criteria:\n\n* A patient who meets any of the following criteria at either the screening or randomization visits will be excluded from the study:\n\n  1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye\n  2. Prior intravitreal investigational agents in the study eye (gene therapy, etc.) at any time\n  3. IOP ≥28 mmHg in the study eye\n  4. History of glaucoma filtration surgery in the past\n  5. Evidence of infectious blepharitis, keratitis, scleritis , or conjunctivitis in either eye within 4 weeks (28 days) of the screening visit.\n  6. Any intraocular inflammation\u002Finfection in either eye within 6 weeks (42 days) of the screening visit.\n  7. History of idiopathic or autoimmune uveitis in the study eye\n  8. Vitreomacular traction or epiretinal membrane in the study eye evident on biomicroscopy or OCT that is thought to affect central vision\n  9. Current iris neovascularization, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye\n  10. History of corneal transplant or corneal dystrophy in study eye\n  11. Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.\n  12. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia, or organized hard exudates\n  13. Inability to obtain photographs, FA, or SD-OCT in the study eye, eg, due to media opacity, allergy to fluorescein dye, or lack of venous access\n  14. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of high dose aflibercept or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications\n  15. Uncontrolled diabetes mellitus as defined by hemoglobin A1c (HbA1c) \\> 14%\n  16. History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) of screening visit\n  17. Known sensitivity to any of the compounds of the study formulation\n  18. Participation in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device\n  19. Pregnant or breastfeeding women\n  20. Men or women of childbearing potential (WOCBP)\\* who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment and during the study.","21 Years",{"count":289,"type":21},15,[97],"Patients with diabetic macular edema (DME) sometimes must undergo vitrectomy surgery (PPV) for diabetic and non-diabetic related issues. Patients may have improved DME with anti-VEGF therapy and ranibizumab has been found to reduce central macular thickness (CMT) with anti-VEGF therapy following vitrectomy. Those patients still require intravitreal injections but the pharmacokinetics of a vitrectomized eye are different than those eyes that have not undergone vitrectomy. The clearance of protein molecules is quicker in vitrectomized eyes so these patients may be more refractory to standard of care anti-VEGF therapy. In rabbit models, the half-life of both bevacizumab and ranibizumab were reduced by a factor 1.8 and 1.3, respectively, after pars plana vitrectomy. In a study examining intravitreal triamcinolone acetonide in human eyes, the half-life was found to be 18.6 days in non-vitrectomized eyes and 3.2 days in vitrectomized eyes, but there was considerable intrasubject variation. Patients with various disease states, including neovascular age-related macular degeneration (nAMD) have been managed with monthly anti-VEGF therapy successfully after vitrectomy surgery. Another study performed by the DRCR net showed that patients with DME treated with anti-VEGF are not affected in the long term if they had had a previous vitrectomy. High dose aflibercept may improve anatomic and visual outcomes in this patient population. Also, high dose aflibercept may allow for longer treatment intervals in these vitrectomized eyes.",[27],[294,295,296,297,141,298,236,299,300,301,302],"diabetic macular edema","diabetes","type 1 diabetes","type 2 diabetes","anti-VEGF","aflibercept 8 mg","vitrectomy","proliferative diabetic retinopathy","non-proliferative diabetic retinopathy","2025-07-07",{"date":305,"type":32},"2025-07-10",{"date":303,"type":32},{"date":308,"type":21},"2027-08-15",{"name":310,"class":39},"Retina Consultants of Orange County",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":320,"briefSummary":321,"conditions":322,"keywords":325,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":199},"100587524","impact-of-intravitreal-faricimab-on-renal-function-in-diabetic-patients-100587524","NCT06929507","Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients","The Impact of Intravitreal Injection of Anti-vascular Endothelial Growth Factor Faricimab on Renal Function in Patients With Diabetes Mellitus","Inclusion Criteria:\n\n* Patients with diabetes\n* Patients with DME or nAMD or macular edema secondary to retinal vein occlusion\n* Patients already receiving nephroprotective drugs\n\nExclusion Criteria:\n\n* Patients with end stage renal disease\n* Pregnancy\n* Patients with other retinal disorders\n* Previous renal transplantation Patients under hemodialysis",{"count":319,"type":21},60,[136],"This study aims to investigate the impact of intravitreal injection of anti-vascular endothelial growth factor (anti VEGF) Faricimab on renal function of diabetic patients. Faricimab is a new anti-VEGF drug which inhibits both VEGF-A and Ang-2 and it is used for the treatment of diabetic macular edema and neovascular age related macular degeneration. It is known that previous anti-VEGF agents has systematic absorption and may cause deterioration in renal function of the patients. However, the effect of Faricimab on kidney function has not been investigated yet. Taking into account that Ang-2 has destructive effect on kidneys, the investigation of the effect of its inhibition in diabetic patients who have already renal function deterioration may provide a valuable information in scientific community.",[323,27,324],"Renal Function Disorder","Neovascular Age Related Macular Degeneration",[326,327,143,294,328],"renal function","intravitreal injection of anti-VEGF","diabetes mellitus","2025-04-19",{"date":331,"type":32},"2025-04-24",{"date":333,"type":32},"2025-03-10",{"date":335,"type":21},"2027-03-10",{"name":337,"class":39},"University Hospital, Alexandroupolis",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":345,"targetDuration":4,"studyType":347,"phases":4,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":40},"100586392","investigating-the-metabolic-and-lipidomic-profiles-that-are-associated-with-varying-grades-of-diabetic-maculopathy-and-retinopathy-in-south-wales-100586392","NCT06914778","Investigating the Metabolic and Lipidomic Profiles That Are Associated With Varying Grades of Diabetic Maculopathy and Retinopathy in South Wales","IMLADRIS","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus\n* Male or female aged 18 - 80 inclusive\n\nExclusion Criteria:\n\n* Participant unable or unwilling to consent to inclusion in the study\n* Prior treatment with intravitreal therapies for DMO\n* Potential participant with a known infective disease that may put the study team at risk (eg. TB, HIV, hepatitis)\n* Age 17 yo or less or 81 yo or older\n* Known underlying genetic condition affecting lipid metabolism",{"count":346,"type":21},120,"OBSERVATIONAL","Diabetes mellitus is a disorder of sugar and fat metabolism which results in damage to the small blood vessels in various organs, this includes the retina - the part of the eye that processes light into a nerve impulse. This leads to damage and blindness via various different mechanisms that are not fully understood.\n\nIn this study the objective is to recruit people with diabetes and various stages of diabetic eye disease and measure a large number of different chemicals within the blood that might be associated with damage and dysfunction within the retina. Additionally, it will examine the different bacteria within the gut that might affect disease in the eye via chemicals circulating in the blood. This will require participants to have blood samples taken and to provide urine samples. The blood will be analysed with specialised instruments to identify specific molecules circulating within the blood. Participants will also need to allow researchers to look at their medical records, previous photographs and specialist scans of the back of the eye to grade their diabetic retinopathy. This will allow us to identify potential ways in which these could be targeted for future benefit for people with diabetes to hopefully prevent deterioration of their vision.",[139,350,27],"Diabetic Retinopathy Associated With Type 2 Diabetes Mellitus",[352,353,354,355,356],"diabetic retinopathy","lipidomics","ophthalmology","diabetic maculopathy","metabolomics","2025-04-08",{"date":359,"type":32},"2025-04-10",{"date":361,"type":32},"2025-03-31",{"date":363,"type":21},"2030-01-01",{"name":365,"class":39},"Hywel Dda Health Board",{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":373,"sex":16,"minAge":374,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":40},"100583667","early-phase-1-effectiveness-of-intravitreal-injection-of-aflibercept-8-mg-in-resistant-diabetic-macular-edema-retinal-vein-occlusion-and-myopic-choroidal-neovascularisation-patients-100583667","NCT06879301","Effectiveness of Intravitreal Injection of Aflibercept 8 mg in Resistant Diabetic Macular Edema, Retinal Vein Occlusion and Myopic Choroidal Neovascularisation Patients","Effectiveness of Intravitreal Injection of Aflibercept 8 mg in Resistant Diabetic Macular Edema and Retinal Vein Occlusion Patients","Inclusion Criteria:\n\nThis study included resistant centrally involved diabetic macular edema (DME) cases\n\n\\-\n\nExclusion Criteria:\n\n1. Patients with a history of intraocular surgery\n2. coincident retinal pathology such as retinal vascular occlusion, CNV due to age-related macular degeneration, angioid streaks, trauma, and choroiditis were excluded from the study.\n3. patients who received other lines of treatment for DME, such as laser photocoagulation, intravitreal injection of steroids\n4. patients known to be glaucomatous or have an IOP ≥20 mmHg were also excluded.\n\n   \\-",true,"20 Years","60 Years",{"count":319,"type":21},[187],"Generally, DM is caused by insufficient insulin secretion in the body; however, the other biological mechanisms remain unclear. Long-term illness in patients with DM damages various organs in the body, such as the eyes, kidneys, and heart, seriously affecting organ function. Nowadays, the quality of life of people has improved significantly, eating habits have changed, sugar intake is increasing, and the number of patients with DM is increasing. Statistics show that in 2017, the number of patients with DM worldwide reached 425 million (aged 20-79 years), which will exceed 600 million in 30 years; moreover, patients in low- and middle-income countries, such as China and India, account for 80 percent of the total DM population (1). According to the WHO, patients with DM worldwide increased to 366 million in 2011, which is expected to increase to 500 million in 2025, with more than 150 million patients experiencing ocular complications, such as diabetic retinopathy (DR) (2, 3). DR is a form of ocular microangiopathy and the most serious DM-related complication; it seriously endangers the health of patients with DM (4). DR pathogenesis includes increased endothelial cells in the eye capillaries, increased intimal thickness, damaged pericytes, microangioma, and damaged blood-retina barrier due to increased permeability of the blood vessels, microvascular obstruction, and neovascularization (NV) (5, 6). Currently, the prevalence of DR is 34.6% worldwide; however, it is higher in some developed countries, reaching 40.3% (7). The proportion of patients with type 1 and 2 DM suffering from blindness due to DR is 3.6% and 1.6%, respectively (8). DR is associated with significantly reduced living standards, huge medical costs, and increased social burden (9, 10).\n\nMany anti-vascular endothelial growth factor (VEGF) drugs exist; however, the use of therapeutic drugs is strictly controlled. The main drugs recommended for treating DM-related visual complications are ranibizumab and aflibercept.",[27,380,381],"Retinal Vein Occlusion (RVO)","Myopic Choroidal Neovascularisation",[383,294],"Aflibercept 8 mg","2025-03-11",{"date":386,"type":32},"2025-03-17",{"date":388,"type":21},"2025-10-19",{"date":390,"type":21},"2025-12-19",{"name":392,"class":39},"Tanta University",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":40},"100570516","phase-2-a-phase-2-study-to-evaluate-the-efficacy-and-safety-of-enn0403-in-subjects-with-dme-100570516","NCT06708260","A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME","A Phase 2, Multicenter, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Two Doses of ENN0403 in Subjects with Diabetic Macular Edema (DME)","Inclusion Criteria:\n\n1. Provide written informed consent;\n2. Aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time throughout the study, and agrees to strictly follow the protocol and study procedures, including restrictions on drug combination during the study;\n3. Diagnosis of type 1 or type 2 diabetes mellitus and HbA1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before screening (at the discretion of the investigator);\n4. The decrease of BCVA is mainly caused byDiabetic Macular Edema in the study eye;\n5. BCVA letter score of ≤ 73 (Snellen 20\u002F40) and ≥ 24 (Snellen 20\u002F320) at screening visit and at baseline. If both eyes meet the inclusion criteria, the study eye will be determined by the investigator from a medical perspective. ( If both eyes meet the inclusion criteria，the eye with poor baseline vision will be selected as the study eye; If the BCVA number is the same, choose the eye with the thicker CRT as the study eye) ；\n6. Optical Coherence Tomography (OCT) foveal CRT at screening measuring ≥300 μm.\n\nExclusion Criteria:\n\n1. Study eye with any eye disease or medical history other than DME that causes or may cause irreversible vision loss;\n2. Study eye had glaucoma filtration surgery in the past or may have the surgery during the study;\n3. Study eye had previously undergone vitreoretinal surgery;\n4. Study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline;\n5. Any eye received intraocular injection of VEGF within 3 months prior to baseline;\n6. History of idiopathic or autoimmune uveitis in any eye;\n7. Uncontrolled glaucoma in any eye (defined as IOP ≥25 mmHg after treatment with anti-glaucoma drugs)\n8. History of allergy to the investigational drug or any ingredient, or to any ingredient used during the treatment;\n9. Use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline (whichever is longer);\n10. Other factors considered inappropriate for inclusion in this study at the discretion of the investigator.",{"count":319,"type":21},[24],"This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.",[27],"2025-02-20",{"date":406,"type":32},"2025-02-21",{"date":408,"type":32},"2024-12-12",{"date":410,"type":21},"2026-02",{"name":412,"class":70},"EnnovaBio",{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":373,"sex":16,"minAge":17,"maxAge":420,"enrollmentInfo":421,"targetDuration":4,"studyType":22,"phases":423,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":4},"100580081","phase-1-study-of-jmkx003948-ophthalmic-suspension-in-healthy-participants-100580081","NCT06832657","Study of JMKX003948 Ophthalmic Suspension in Healthy Participants","A Randomized, Double-blind, Placebo-controlled Phase 1 Study of JMKX003948 Ophthalmic Suspension to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) in Healthy Participants","Inclusion Criteria:\n\n1. Healthy adult males and\u002For females, 18 to 45 years of age (inclusive) at the date of signed consent form.\n2. Body mass index (BMI) greater than or equal to 18 and less than 32 (kg\u002Fm2) and a minimum body weight of 45 kg.\n3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.\n4. Women of child-bearing potential and sexually active males willing to use highly effective methods of contraception from screening until 3 months after last dose of study drug. In addition, participants must not donate sperm\u002Fegg for the time period specified above.\n\nExclusion Criteria:\n\n1. History of disease of ocular surface, fundus, central nervous system, psychiatric and psychological condition, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic\u002Fendocrine system, or other disease that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with study evaluations.\n2. Any abnormal examination with clinical significance may interfere with study evaluations in opinion of the Investigator (or medically qualified designee).\n3. History of eye trauma or surgery including LASIK\u002FLASEK.\n4. Any corrected visual acuity \\\u003C 20\u002F20, or intraocular pressure ≥ 21 mmHg.\n5. Clinically significant abnormalities on ophthalmic examination that would hinder the assessment of the eye or data collection at the discretion of the Investigator and\u002For ophthalmologist (or medically qualified designee).","45 Years",{"count":422,"type":21},40,[424],"PHASE1","The study is a randomized, double-blind, placebo-controlled, phase 1 study of JMKX003948 Ophthalmic Suspension to evaluate the safety, tolerability and PK of single and multiple ascending doses in healthy participants.\n\nParticipant will be randomized to receive either JMKX003948 Ophthalmic Suspension (1%, 2%, 3% or 5%) or matching placebo (JMKX003948 Ophthalmic Suspension: placebo= 6: 2, N=8 per cohort).\n\nFive cohorts (Cohort 1-5) are planned. Cohorts could also de-escalate to a lower concentration if current formulation was not tolerated (Cohort 1b, 2b and 3b). In case of de-escalation, Cohort 1b and 2b will continue to escalate to Cohort 1c and Cohort 2c, respectively.\n\nParticipants will be admitted to the site on Day -1 after screening (up to 28 days), and remain domiciled until Day 14 for Cohort 1-4, Day 8 for other cohorts.",[427,27],"Age-Related Macular Degeneration (AMD)","2025-02-12",{"date":430,"type":32},"2025-02-18",{"date":432,"type":21},"2025-02",{"date":434,"type":21},"2025-12",{"name":436,"class":70},"Jemincare"]