[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-retinopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-retinopathy":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,62,0,25,[9,46,74,109,131,151,174,199,228,251,277,303,323,347,368,389,411,437,456,491,516,541,564,604,629],{"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":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100642444","phase-2-surabgene-lomparvovec-administered-in-the-suprachoroidal-space-in-adult-participants-with-diabetic-retinopathy-without-center-involved-diabetic-macular-edema-100642444","NCT07592273","Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema","An Operationally Seamless Phase 2b\u002F3, Multicenter, Randomized, Masked, Sham-controlled Study to Evaluate the Efficacy and Safety of Surabgene Lomparvovec (Sura-vec) Delivered Via Suprachoroidal Space (SCS) Injection Targeting Subjects With Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema (CI-DME) (NAAVIGATE)","NAAVIGATE","Inclusion Criteria:\n\nOcular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)\n\n* Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (early treatment diabetic retinopathy study-diabetic retinopathy severity scale \\[DRSS\\] level 47 or 53) for which panretinal photocoagulation (PRP) or anti- vascular endothelial growth factor (VEGF) can be safely deferred for at least 6 months after Screening Visit 1.\n* Best-corrected visual acuity (BCVA) in the study eye of \\>= 69 Early treatment diabetic retinopathy study letters (approximate Snellen equivalent 20\u002F40 or better) at Screening Visit 1.\n\nSystemic\n\n• Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)\\\u003C 12% within 60 days prior to Screening Visit 1.\n\nExclusion Criteria:\n\nOcular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)\n\n* Presence of active center involved-diabetic macular edema (CI-DME) in the study eye as determined by spectral domain optical coherence tomography (SD-OCT) evaluated by the central reading center (CRC), using the following threshold:\n\nCentral retinal thickness (CRT) \\>= 320 μm as measured by Heidelberg Spectralis SD-OCT (conversion to equivalent measurement is required and performed by the CRC if imaging is done with another SD-OCT instrument).\n\n* Active ocular inflammation including scleral inflammation (including episcleritis) or ocular\u002F periocular infection present in either eye at Screening Visit 1 or Screening Visit 2\n* Neovascularization from a cause other than DR, per investigator\n* Evidence or documented history of panretinal photocoagulation (PRP) or retinal laser therapy\n* History of intravitreal therapy, including anti-VEGF and long- or short-acting steroid therapy, within the prior 6 months and documentation of more than 10 prior anti-VEGF or short acting steroid intravitreal injections within 36 months of Screening Visit 1\n* Pregnant and breastfeeding individuals are excluded from this clinical study.\n\nSystemic\n\n* Initiation of intensive insulin treatment (pump or multiple daily injections) within the past 6 months or plans to do so within 52 weeks after Day 1\n* Initiation of any treatment containing a GLP-1 receptor agonist within the 3 months prior to Screening Visit 1 or plans to do so within 52 weeks after Day 1\n* Pregnant and breastfeeding individuals are excluded from this clinical study",{"count":55,"type":22},576,[57,58],"PHASE2","PHASE3","Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lomparvovec (sura-vec) as a potential one-time gene therapy administered in the suprachoroidal space (SCS) for the treatment of diabetic retinopathy (DR) and prevention of vision-threatening events (VTEs) in participants with non-proliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME).\n\nThis study will consist of 3 portions: a Phase 2b portion, a Phase 3 portion, and a bilateral treatment portion. Approximately 576 adult participants will be enrolled in the study across multiple sites in the United States and Puerto Rico.\n\nIn the Phase 2b and Phase 3 portions, participants will be randomized to different groups to receive sura-vec and prophylactic steroids or sham and artificial tears in their study eye. If assigned to sham, participants will be given an opportunity to cross over and receive treatment with sura-vec. In the bilateral treatment portion, participants will be enrolled to receive sura-vec and prophylactic steroids in both eyes. In all 3 portions, follow-up in the study will continue through 5 years following administration of sura-vec in each eye.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[29],[29,62,63],"Severe Nonproliferative Diabetic Retinopathy","ABBV-RGX-314","2026-06-29",{"date":66,"type":37},"2026-07-01",{"date":68,"type":37},"2026-06-01",{"date":70,"type":22},"2036-01",{"name":72,"class":44},"AbbVie",11,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":4,"leadSponsor":105,"locationsCount":108},"100170772","national-eye-institute-biorepository-for-retinal-diseases-100170772","NCT01496625","National Eye Institute Biorepository for Retinal Diseases","NEI Intramural Biorepository for Retinal Diseases","* INCLUSION CRITERIA:\n\nParticipants will be eligible if they:\n\n* Have the ability to understand and sign an informed consent or have a parent\u002Flegal guardian to do so if they are minor children.\n* Manifest diagnosed or undiagnosed retinal disease(s), or could serve as an unaffected control suitable for comparison to participants with various retinal diseases, particularly AMD and diabetic retinopathy (taking into account matching factors such as age and past ocular history).\n\nEXCLUSION CRITERIA:\n\nParticipants will not be eligible if they:\n\n* Are unable or unwilling to give informed consent that includes collection and study of at least one peripheral blood sample.\n* Are unable or unwilling to give informed consent that includes use of NIH medical records and clinical samples for research.\n* Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment.",true,"2 Years","120 Years",{"count":85,"type":22},650,"OBSERVATIONAL","Background:\n\n\\- To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time. They also want to study body tissues and blood to understand the nature of eye disease. Studying genes, cells, and tissues may help them understand why some people get eye problems and others do not, or why some people respond to treatment while others do not. Researchers want to collect physical samples and personal data to develop a National Eye Institute database.\n\nObjectives:\n\n\\- To collect health information and blood and tissue samples from people with and without eye diseases, to be used in research studies.\n\nEligibility:\n\n* Individuals at least 2 years of age with different types of eye disease.\n* Healthy volunteers with no history of eye disease.\n\nDesign:\n\n* Participants may be recruited from National Eye Institute studies or may be referred from other sources.\n* Participants will be screened with a physical exam and medical history. They will also have a full eye exam. Questions will be asked about family medical history, especially about eye disease.\n* Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and urine, may be collected as needed. Adult participants may also provide a skin sample.\n* Tissue or fluid from eye collected as part of eye care or treatment may also be added to the database.\n* No treatment will be provided as part of this study.",[89,29,90,91,92],"Age-Related Macular Degeneration","Von Hippel-Lindau Syndrome","Retinal Disease","Retinal Vein Occlusion",[94,91,29,95,96,97,98,99,100],"Biological Specimens","Phenotype-Genotype correlation","Age-Related Macular Degeneration (AMD)","Natural History","AMD","Healthy Volunteer","HV","2026-06-27",{"date":34,"type":37},{"date":104,"type":37},"2012-06-18",{"name":106,"class":107},"National Eye Institute (NEI)","NIH",1,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":108},"100641325","phase-1-a-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-of-ro7663498-following-intravitreal-administration-in-participants-with-diabetic-retinopathy-100641325","NCT07588100","A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy","A Multicenter, Non-Randomized, Open-Label, Multiple-Ascending-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7663498 Following Intravitreal Administration in Participants With Diabetic Retinopathy","CENOTE","Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n* Diagnosis of Diabetes Mellitus (DM) (Type 1 or Type 2), as defined by the World Health Organization and\u002For American Diabetes Association\n\nOcular Inclusion Criteria for the Study Eye\n\n* BCVA score at screening of \\>= 19 letters in study eye using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity testing charts\n* Non-proliferative diabetic retinopathy (NPDR) as assessed by the investigator and confirmed by the Central reading center (CRC)\n* Collection of \\>= 90 micro liter (μL) AH deemed feasible and safe by the investigator.\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria:\n\n* Any known hypersensitivity to any of the following compounds: fluorescein; any dilating, anesthetic, or povidone iodine eye drops; or any excipients contained in the treatments used in this study.\n* History of hypersensitivity to biologic agents, the investigational drug, or any of the excipients contained in the formulation administered IVT or systemically.\n\nOcular Exclusion Criteria for the Study Eye\n\n* Center-involved Diabetic Macular Edema (DME)\n* Any history or concurrent ocular conditions\u002Fprocedures and\u002For visual system conditions of the below.\n* Vitreoretinal surgery\u002Fpars plana vitrectomy.\n* Any history of glaucoma surgery or planned glaucoma surgery during the study.\n* Uncontrolled glaucoma\n* Anterior segment neovascularization.\n* Vitreous or preretinal hemorrhage.\n* Any ocular disease other than DR and DME that may Confound assessment of the retina in the opinion of the investigator or Confound development of worsening DR, DME, or retinal nonperfusion.\n* Any presence of active intraocular inflammation on Day 1 (i.e., Standardization of Uveitis Nomenclature \\[SUN\\] criteria \\> 0 or National Eye Institute \\[NEI\\] vitreous haze grading \\> 0) or any history of IOI.\n* Aphakia or previous violation of the posterior capsule in the study eye\n\nOcular Exclusion Criteria for the Non-study Eye\n\n* BCVA \\\u003C 38 letters",{"count":118,"type":22},30,[25],"This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with diabetic retinopathy (DR).",[29],"2026-06-19",{"date":124,"type":37},"2026-06-23",{"date":126,"type":37},"2026-06-18",{"date":128,"type":22},"2027-12-30",{"name":130,"class":44},"Hoffmann-La Roche",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":147,"locationsCount":150},"100445358","biomarker-of-diabetic-retinopathy-100445358","NCT05079399","Biomarker of Diabetic Retinopathy","Inclusion Criteria:\n\n* Ability to cooperate with imaging procedures.\n* Health status: established type 2 diabetes\n* No history of panretinal photocoagulation (PRP)\n* No history of treatment with intravitreal agents for past 12 months\n\nExclusion Criteria:\n\n* Previous or current malignancy\n* Acute or chronic infection (HIV, hepatitis B or C, tuberculosis)\n* Cerebral vascular accident or cerebral vascular procedure\n* Current pregnancy\n* History of organ transplantation\n* Presence of a graft (to avoid any effect of the graft)\n* History of previous vitrectomy\n* Subjects with a history of age-related macular degeneration age-related macular degeneration (AMD), glaucoma, uveitis, and branched or central vein occlusion.",{"count":138,"type":22},192,"Diabetic retinopathy (DR) is a complication of diabetes in which blood vessels supplying blood to the back of the eye (retina) are dysfunctional. This can lead to an improper supply of oxygen and nutrients to the retinal tissue, or it may trigger the formation of new blood vessels in response to the oxygen\u002Fnutrient deficiency. Ultimately affecting the normal vision. There is no known marker that will provide information on the health status of retinal blood vessels. Using highly specialized cells in the blood, this study will try to discover a marker of DR.",[29],"2026-06-15",{"date":143,"type":37},"2026-06-17",{"date":145,"type":37},"2022-01-01",{"date":34,"type":22},{"name":148,"class":149},"Indiana University","OTHER",3,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":108},"100401313","optical-coherence-tomography-angiography-in-subjects-with-retinal-vascular-disease-100401313","NCT04505618","Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease","OCTA-RVD","Exclusion Criteria:\n\n* Both subjects with diseases and controls:\n* Children (age\\\u003C18)\n* Pregnant females\n* Developmentally delayed subjects\n* Subjects unable to provide informed consent\n* Inability to cooperate with tests and study instructions\n* Images with motion artifact or signal strength \\\u003C 7\n* History of glaucoma\n* History of age-related macular degeneration\n* History of any visually significant eye disease\n* History of proliferative diabetic retinopathy\n* History of any inflammatory disease\n* History of heart disease\n* History of thyroid disease.\n* Additional criteria for controls:\n* History of any type of Diabetes Mellitus\n* History of any type of Hypertension","99 Years",{"count":160,"type":22},1050,[162],"NA","This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.",[29,92,165,166],"Hypertension,Essential","Retinal Vascular Disorder",{"date":143,"type":37},{"date":169,"type":37},"2019-10-01",{"date":171,"type":22},"2027-09-01",{"name":173,"class":149},"Johns Hopkins University",{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":81,"sex":17,"minAge":182,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":108},"100343530","village-integrated-eye-worker-trial-ii-100343530","NCT03752840","Village-Integrated Eye Worker Trial II","Village-Integrated Eye Worker Trial II (VIEW II):A Cluster-randomized Trial of the Effectiveness of Community-based Ocular Disease Screening","VIEW II","Community level\n\nInclusion Criteria:\n\n* Located in catchment area of Bharatpur Eye Hospital or Lumbini Eye Institute\n* Reachable by non-4WD vehicle\n* Urban or peri-urban\n\nExclusion Criteria:\n\n\\- Local leaders unwilling to participate\n\nPerson level\n\nInclusion Criteria:\n\n* 60 years and older\n* Residing in the community during the time of the census\n\nExclusion Criteria:\n\n\\- Unwilling to participate","60 Years",{"count":184,"type":22},60200,[162],"The vast majority of blindness is avoidable. The World Health Organization (WHO) estimates that 80% of cases of visual impairment could be prevented or reversed with early diagnosis and treatment. The leading causes of visual impairment are cataract and refractive error, followed by glaucoma, age-related macular degeneration (AMD), and diabetic retinopathy (DR). Loss of vision from these conditions is not inevitable; however, identifying cases early and linking cases with appropriate care remain significant challenges.\n\nTo address the global burden of avoidable blindness, eye care systems must determine optimal strategies for identifying people with or predisposed to visual impairment beyond opportunistic screening. Outreach programs can prevent blindness both by screening for asymptomatic disease like age-related macular degeneration (AMD), diabetic retinopathy (DR), and glaucoma and case detection of symptomatic disease like cataract and refractive error. Eye care systems have developed numerous approaches to these identification methods, including screening using telemedicine and case detection via cataract camps or health worker models, but no studies have been conducted on the comparative effectiveness or cost effectiveness of these various approaches.\n\nTechnology promises to greatly improve access to sophisticated eye care. AMD, DR, and glaucoma can result in irreversible vision loss, and early diagnosis and effective treatment can prevent progression. Thus, mass screening programs may prevent progression and improve the vision of a population. However, mass screening for eye disease is currently not recommended. Although self-evident that early detection can prevent blindness for an individual, no randomized controlled trial has been able to demonstrate that screening improves visual acuity at the regional level. However, recent technological advances promise to dramatically change the equation by allowing non-medical personnel to use mobile, easy-to-use retinal imaging devices to diagnose screenable eye diseases such as AMD, DR, and glaucoma. Mobile technology could also transform the way clinics communicate with their patients, improving linkage to and retention in care.\n\nOptical coherence tomography (OCT) is an ideal test for screening. OCT can be performed through an undilated pupil and is less subject to optical aberrations due to cataract than is fundus photography. OCT machines have pre-installed algorithms to screen for glaucoma, and major anatomical abnormalities can easily be detected even by novice technicians. The infrared image allows detection of referable diabetic retinopathy, and newer OCT angiography machines offer even more discrimination of early diabetic retinopathy. OCT machines are ever more portable, and could be feasibly used in mobile screening programs.\n\nThe investigators propose a large cluster-randomized trial to compare two population level blindness prevention programs: (1) a state-of-the-art screening program employing OCT, fundus photography, and intraocular pressure testing to screen for glaucoma, DR, and AMD followed by enhanced linkage-to-care to the local eye hospital, and (2) a screening program involving only visual acuity assessment. An initial door-to-door census will assess baseline visual acuity in both study arms. The investigators will compare visual acuity between the two arms through a second door-to-door census 9 years later (primary outcome).",[188,29,189],"Age-related Macular Degeneration","Glaucoma","2026-06-05",{"date":192,"type":37},"2026-06-09",{"date":194,"type":37},"2019-04-21",{"date":196,"type":22},"2029-08-31",{"name":198,"class":149},"University of California, San Francisco",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":219,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":224,"leadSponsor":226,"locationsCount":108},"100640257","community-based-eye-screening-with-structured-referral-tracking-for-preventing-avoidable-blindness-in-adults-in-rawalpindi-pakistan-100640257","NCT07611682","Community-Based Eye Screening With Structured Referral Tracking for Preventing Avoidable Blindness in Adults in Rawalpindi, Pakistan","Community-Based Eye Screening With a Structured Referral Tracking Intervention for the Prevention of Avoidable Blindness Among Adults in Rawalpindi District, Pakistan","SIGHT","Inclusion Criteria:\n\n* Adults aged 18 years or above\n* Individuals diagnosed with visual impairment or eye conditions requiring referral to a tertiary eye care facility\n* Permanent residents of Rawalpindi District, Pakistan\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Individuals already undergoing treatment for the identified eye condition\n* Individuals requiring emergency ophthalmic care\n* Severe systemic or physical illness limiting follow-up\n* Individuals unable to provide informed consent",{"count":208,"type":22},500,[162],"This cluster randomized controlled trial aims to evaluate the effectiveness of a Structured Referral Tracking (SRT) intervention in improving referral completion among adults identified with avoidable blindness during community-based eye screening camps in Rawalpindi District, Pakistan. Ten community clusters will be randomized into intervention and control groups. Participants in the intervention group will receive structured referral counseling, weekly reminder calls or messages, and customized referral guidance for eight weeks, while the control group will receive standard referral procedures. The primary outcome is referral completion at a tertiary eye hospital within eight weeks after screening. Secondary outcomes include knowledge regarding avoidable blindness, treatment satisfaction, feasibility, acceptability, and barriers influencing referral completion.",[212,213,29],"Cataract","Refractive Error",[215,216,212,213,29,217,218],"Community Eye Screening","Avoidable Blindness","Referral System","Structured Referral Tracking","NOT_YET_RECRUITING","2026-06-02",{"date":222,"type":37},"2026-06-04",{"date":68,"type":22},{"date":225,"type":22},"2026-11-30",{"name":227,"class":149},"Health Services Academy, Islamabad, Pakistan",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":108},"100535842","video-based-patient-education-intervention-for-diabetic-eye-screening-in-latinx-communities-100535842","NCT06257082","Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities","Development of a Culturally Adapted, Video-based Patient Education Intervention to Increase Diabetic Eye Screening and Teleophthalmology Use in Latinx Communities","Inclusion Criteria (online survey participants):\n\n* Self-Identifies as Hispanic or Latino\n\nInclusion Criteria (patient video testimonials):\n\n* Self-Identifies as Hispanic or Latino\n* diagnosed with diabetes\n* treated at Access Community Health Centers and UW Health in Madison, WI\n\nInclusion Criteria (clinician video testimonials):\n\n* Self-Identifies as Hispanic or Latino\n* clinician who treats patients with diabetes at Access Community Health Centers and UW Health in Madison, WI\n\nInclusion Criteria (focus group participants):\n\n* Self-Identifies as Hispanic or Latino\n* diagnosed with type 1 or type 2 diabetes\n\nExclusion Criteria:\n\n\\-",{"count":236,"type":22},1526,[162],"An online survey (n=1,500) and 4 focus groups will be conducted with Latinx patients with diabetes (n=20) to obtain preliminary data regarding whether and how patient and clinician video testimonial interventions (n=6) increase eye health literacy and trust in healthcare.",[29],[241],"teleophthalmology","2026-05-13",{"date":244,"type":37},"2026-05-14",{"date":246,"type":37},"2025-05-21",{"date":248,"type":22},"2026-09",{"name":250,"class":149},"University of Wisconsin, Madison",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":182,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":108},"100588607","strategies-for-improving-linkage-to-care-after-eye-disease-screening-100588607","NCT06943599","Strategies for Improving Linkage-to-Care After Eye Disease Screening","Village Integrated Eye Worker II Linkage-to-Care Trial","Inclusion Criteria:\n\n\\- Participant of the VIEW II study referred to the eye hospital at their eye screening visit.\n\nExclusion Criteria:\n\n* Residence in an area without reliable mobile connectivity",{"count":259,"type":22},3000,[162],"The goal of this randomized, parallel-group, controlled trial is to compare methods of improving linkage-to-care for participants in the Village Integrated Eye Worker II (VIEW II) trial who are referred to the eye hospital following eye disease screening. Participants who are referred to the hospital at an eye screening visit will be randomized to three different linkage-to-care interventions: (1) text message reminders, (2) reminders from health workers, or (3) no intervention. The primary outcome of the trial will be whether or not the participant presented to the eye hospital for a referral visit by 21 days following screening.",[263,29,189],"Age Related Macular Degeneration",[265,266,267,268],"Eye Diseases","mass screening","patient compliance","retention in care","2026-04-27",{"date":271,"type":37},"2026-04-29",{"date":273,"type":37},"2026-02-01",{"date":275,"type":22},"2028-06-30",{"name":198,"class":149},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":17,"minAge":284,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":219,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":108},"100574797","leveraging-artificial-intelligence-to-prevent-vision-loss-from-diabetes-100574797","NCT06763952","Leveraging Artificial Intelligence to Prevent Vision Loss From Diabetes","Multicenter National Parallel Cluster Randomized Controlled Superiority Trial Comparing an Artificial Intelligence-Based Screening Strategy to Usual Care for Improving Eye-Care Follow-Up Among Patients With Diabetes (AI-BRIDGE Trial)","Inclusion Criteria:\n\n* Diagnosed with type 1 or 2 diabetes\n* No known diabetic eye disease\n* Medicaid as their primary insurance\n* Not had an eye exam in the prior year\n\nExclusion Criteria:","22 Years",{"count":286,"type":22},4000,[162],"This study aims to investigate whether a novel artificial intelligence based screening strategy (AI-Based point of caRe, Incorporating Diagnosis, SchedulinG, and Education or AI-BRIDGE), which allows primary care providers to screen patients for vision-threatening diabetic eye disease in the primary care clinic, improves screening and follow-up care rates across race\u002Fethnicity groups and reduces racial\u002Fethnic disparities in screening.",[29,290],"Diabetes Mellitus",[292,293,294,295,296],"Artificial Intelligence","AI","diabetic eye disease","cluster randomized trial","pragmatic trial",{"date":271,"type":37},{"date":299,"type":22},"2026-08-01",{"date":301,"type":22},"2030-05",{"name":250,"class":149},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":108},"100338003","soluble-cluster-of-differentiation-160-scd160-in-sera-and-intra-ocular-fluids-association-with-ischaemic-retinopathies-100338003","NCT03680794","Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies","sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies","inclusion criteria :\n\n* over 18 years old\n* with social security affiliation\n* willing to participate this study non-inclusion criteria :\n* any prior (3 months) or concomitant treatment with anti-VEGF therapy, corticosteroids, or immunosuppressive agents\n* any history of previous vitreoretinal surgery, ocular tumor, severe ocular trauma, severe intraocular, periocular infection, inflammation, or radiation\n* any serious allergy to the fluorescein sodium for injection in angiography\n* any history of previous systemic anti-VEGF treatment\n* any history of inflammatory or auto-immune disease\n* any active extraocular inflammation or infection in the last 4 weeks before surgery exclusion criteria :\n* Patients with C-reactive protein CRP \\> 10mg\u002FmL (serum sampling during surgery)",{"count":311,"type":22},120,[162],"CD160 represents a new angiogenic factor as its specific engagement by an agonist monoclonal antibody directed against human CD160 reduced angiogenesis of endothelial cells with a distinct mechanism from current angiogenic therapies that target the VEGF\u002FVEGF-R pathway. A soluble form of CD160, sCD160, has been found to be highly expressed in the vitreous and the sera of patients with severe diabetic retinopathies, and can now be dosed with help of an ELISA test.\n\nThe investigators aim to evaluate the association between ischaemic retinopathies (patients with or without) and sCD160 concentrations in the vitreous, the aqueous humour and the serum.",[29,92],{"date":316,"type":37},"2026-04-30",{"date":318,"type":37},"2018-06-27",{"date":320,"type":22},"2028-02-27",{"name":322,"class":149},"CHU de Reims",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":81,"sex":17,"minAge":331,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"100594099","developing-and-testing-a-model-to-identify-preventive-vision-loss-among-older-patients-in-general-practice-100594099","NCT07015034","Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice","Developing and Testing a Model to Identify Preventive Vision Loss Among Older Patients in General Practice (DETECT)","DETECT","Inclusion Criteria:\n\n* +70 years\n* One or more chronic diseases\n* Are followed by GP du to chronic disease\n\nExclusion Criteria:\n\n* Dementia diagnosis\n* Known eye-diseases or are currently followed by private ophtalmologist\n* Not able to understand Danish","70 Years",{"count":333,"type":22},460,[162],"In this cohort study, the investigators will test vision screenings in Danish general practice for patients over 70 years of age with minimum one chronic condition. The main outcome is detection of vision impairment and secondary outcome is detection of conditions needing ophthalmologic follow-up but not presenting vision impairment at present time.",[337,189,89,212,29],"Vision Impairment and Blindness","2026-04-23",{"date":271,"type":37},{"date":341,"type":37},"2024-05-15",{"date":343,"type":22},"2027-07-15",{"name":345,"class":149},"University of Copenhagen",2,{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":108},"100635660","defining-retinal-structures-using-hyperspectral-retinal-imaging-100635660","NCT07555574","Defining Retinal Structures Using Hyperspectral Retinal Imaging","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Able to provide informed consent\n* Willing and able to attend a study visit at the Centre for Eye Research Australia\n* Participants with diagnosed retinal or optic nerve disease (e.g., diabetic retinopathy, glaucoma, age-related macular degeneration)\n* Age- and sex-matched healthy control participants without known retinal or optic nerve disease\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Ocular conditions preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous haemorrhage)\n* Known contraindication to pharmacological pupil dilation\n* History of narrow anterior chamber angle or risk of angle closure glaucoma where dilation is considered unsafe\n* Any condition that, in the investigator's opinion, would compromise participant safety or image quality",{"count":354,"type":22},1000,[162],"This study evaluates hyperspectral retinal imaging as a novel, non-invasive imaging technique to characterise retinal and optic nerve structures in healthy individuals and patients with eye disease. Hyperspectral imaging captures retinal data across multiple wavelengths to generate detailed spectral information that may reveal features not visible with conventional retinal photography.\n\nApproximately 1000 participants will undergo multi-modal ophthalmic imaging in Melbourne, Australia, including hyperspectral imaging, OCT, fundus photography, and related tests. The study aims to compare hyperspectral imaging with standard imaging methods and assess its ability to identify retinal biomarkers associated with diseases such as diabetic retinopathy, glaucoma, and age-related macular degeneration.",[89,29,189,358,359],"Retinal Diseases","Healthy Volunteers","2026-04-21",{"date":271,"type":37},{"date":363,"type":37},"2025-01-01",{"date":365,"type":22},"2028-12-30",{"name":367,"class":149},"Center for Eye Research Australia",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":17,"minAge":374,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":150},"100579215","optimization-and-evaluation-of-the-diagnosis-and-treatment-system-for-diabetic-retinopathy-in-type-2-diabetes-mellitus-100579215","NCT06821399","Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Meets the diagnostic criteria for type 2 diabetes in the \"China Type 2 Diabetes Prevention and Treatment Guidelines (2020 Edition)\";\n\n  * Aged between 20 and 79 years old, without other severe underlying diseases; ③ Possesses full cognitive and literacy abilities; ④ Volunteers to participate in this study and are willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* Those who have been diagnosed with type 1 or other types of diabetes;\n\n  * Those with severe cardiac, pulmonary, hepatic, or renal insufficiency;\n\n    * Those with mental confusion, speech disorders, or dementia, etc.;\n\n      * Those who are unable to take care of themselves, bedridden, or have mobility impairments; ⑤ Women who are breastfeeding or pregnant;\n\n        * Those with a recent history of surgery, trauma, acute major vascular complications, or infectious diseases.","20 Years","79 Years",{"count":377,"type":22},2920,"This study aims to integrate clinical indicators and features of fundus images, combined with metabolomics, to construct an early warning model for diabetic retinopathy (DR) in type 2 diabetes. By combining clinical indicators with metabolomics, the investigators aim to establish a precise DR typing model based on the age of diabetes onset (early-onset diabetes, late-onset diabetes) and based on the coexistence with two types of diabetic macrovascular complications. A multidisciplinary collaboration will be conducted for comprehensive management of DR to control the progression of moderate-stage DR. Cloud-based patient rooms combined with continuous glucose monitoring (CGM) will further explore the role of integrated diabetes retinopathy ward management models in the management of patients undergoing diabetes retinopathy surgery, pioneering a new model for the management of advanced DR.",[380,29,381],"Diabetes","Type 2 Diabetes Mellitus (T2DM)",{"date":338,"type":37},{"date":384,"type":37},"2025-02-01",{"date":386,"type":22},"2028-07-31",{"name":388,"class":149},"Yufan Wang",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":396,"maxAge":397,"enrollmentInfo":398,"targetDuration":4,"studyType":23,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":108},"100404521","phase-2-sleep-diabetic-retinopathy-and-melatonin-100404521","NCT04547439","Sleep, Diabetic Retinopathy and Melatonin","Sleep and Circadian Regulation in Diabetic Retinopathy: The Role of Intrinsically Photosensitive Retinal Ganglion Cells and Melatonin Supplementation","Inclusion Criteria:\n\n* Type 2 diabetes (clinically diagnosed, taking anti-diabetes medications or history of elevated A1C≥6.5%)\n* 40-65 years of age\n* Diabetic retinopathy of at least moderate degree\n\nExclusion Criteria:\n\n* use of melatonin\n* antidepressants or antipsychotics\n* illicit drug use\n* night shift work or travel beyond 2 time zones in the month before enrollment\n* end stage renal disease requiring renal replacement therapy\n* history of stroke or transient ischemic attacks\n* history of dementia or memory impairment\n* uncontrolled congestive heart failure or recent hospitalization for cardiac condition (6 months)\n* chronic obstructive pulmonary disease requiring oxygen\n* severe chronic liver disease such as cirrhosis\n* ongoing treatment for major medical problems such as cancer\n* history of severe hypoglycemia defined as hypoglycemic episodes requiring assistance from others within the past six months.\n* Significant depressive symptoms\n* untreated severe OSA (AHI≥ 30 events\u002Fhour),\n* uncontrolled hypertension (blood pressure ≥ 160\u002F100 mmHg),\n* uncontrolled diabetes (A1C ≥ 11%),\n* abnormal TSH\n* abnormal liver function (AST or ALT\\>3x upper limits of normal\n* use of sedatives and hypnotics.\n* clinically significant epiretinal membranes, clinically significant lens opacities, or cystoid macular edema, iris neovascularization, iris atrophy, or an asymmetrically shaped pupil, nuclear sclerotic, posterior subcapsular, or cortical lens opacities greater than 2+, a history of pan-retinal photocoagulation.\n* hemoglobin \\\u003C11.5 g\u002FdL in women and \\\u003C13.5 g\u002FdL in men.","40 Years","65 Years",{"count":399,"type":22},42,[57],"This study explores the use of melatonin in patients with diabetic retinopathy",[290,29],"2026-04-20",{"date":360,"type":37},{"date":406,"type":37},"2021-02-03",{"date":408,"type":22},"2026-06",{"name":410,"class":149},"University of Illinois at Chicago",{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":419,"maxAge":19,"enrollmentInfo":420,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":422,"conditions":423,"keywords":426,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":108},"100628198","longitudinal-observational-study-of-diabetic-retinopathy-progression-in-type-2-diabetes-patients-100628198","NCT07458516","Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients","IMaging Pre-PrOlifeRative sTAge of Diabetic retiNopaThy to Guarantee Timely Treatment - IMPORTANT","IMPORTANT","Inclusion Criteria:\n\n* Type 2 diabetes mellitus (T2D) according to 1985 World Health Organization (WHO) criteria.\n* Age between 35 and 80 years.\n* Best-corrected visual acuity (BCVA) ≥ 69 letters (20\u002F40).\n* Refraction with a spherical equivalent less than 5 diopters.\n* Non-proliferative diabetic retinopathy (NPDR; DRSS levels 43, 47, 53) or mild proliferative diabetic retinopathy (PDR; DRSS level 61: Neovascularization Elsewhere (NVE) \\\u003C ½ disc area in ≥ 1 quadrant, no Neovascularization of the Disc (NVD), no vitreous or sub-hyaloid hemorrhage), in which panretinal photocoagulation (PRP) and\u002For intravitreal anti-VEGF treatment can safely be deferred for at least 6 months, based on consensus between patient and investigator - using ETDRS criteria, 7-field equivalent area on ultra-widefield fundus imaging.\n* Ability to understand and sign the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Central subfield thickness (CST) \\> 400 μm (fluid allowed if CST ≤ 400 μm and foveal contour is normal, as determined by the Central Reading Centre, and treatment is not immediately required).\n* Any sign of retinal fibrovascular proliferation.\n* Uncontrolled glaucoma (intraocular pressure \\> 25 mmHg regardless of concomitant IOP-lowering medications) or neovascular glaucoma.\n* Any sign of iris neovascularization, vitreous, or pre-retinal hemorrhage.\n* Other retinal vascular diseases (ocular ischemic syndrome, retinal arterial or venous occlusion, exudative age-related macular degeneration, etc.).\n* Previous panretinal photocoagulation (PRP) or intravitreal injection treatment.\n* Any eye surgery within 6 months prior to the inclusion visit.\n* Significant media opacities including severe cataract, corneal scarring or edema, or vitreous hemorrhage that precludes fundus evaluation.\n* Pupil dilation \\\u003C 5 mm.","35 Years",{"count":421,"type":22},100,"The purpose of this clinical study is to explore imaging, functional and systemic biomarkers of diabetic retinopathy (DR) progression, in Type 2 Diabetes (T2D) patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) using state of the art methodologies, commonly applied in clinical practice, over a period of two years. This study will provide longitudinal data to better understand retinal changes in moderate to severe diabetic retinopathy and early proliferative diabetic retinopathy and help guide timely interventions to prevent vision loss.",[29,424,425,91],"Diabetes Mellitus, Type 2","Diabetic Complication",[427],"Disease biomarkers","2026-03-09",{"date":430,"type":37},"2026-03-11",{"date":432,"type":37},"2025-11-24",{"date":434,"type":22},"2028-06",{"name":436,"class":149},"Association for Innovation and Biomedical Research on Light and Image",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":419,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":108},"100625036","analysis-of-dr-progression-to-identify-risks-and-need-for-treatment-100625036","NCT07417410","Analysis of DR Progression to Identify Risks and Need for Treatment","ALERT","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes according to the 1985 WHO criteria.\n* Age between 35 and 90 years.\n* Retrospective visit or referenced patients. For the retrospective visit, a documented follow-up of 1-5 years is required, with at least one clinical visit. For the referenced patients, it is required that they have either diabetic retinopathy at the baseline visit, the presence of at least one cardiovascular risk factor at the baseline visit, or cardiovascular complications at the baseline visit.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Previous laser photocoagulation or intravitreal injections (consider if corticosteroids were administered).\n* Presence of clinically significant macular edema (CSME) with vision loss or requiring immediate treatment.\n* Proliferative diabetic retinopathy.\n* Any ocular surgery within the previous 3 months.\n* Renal Replacement Therapy (Hemodialysis, Peritoneal Dialysis).\n* Severe systemic illness, subject to investigator's judgment.","90 Years",{"count":354,"type":22},"The goal of this observational study is to understand whether vascular and structural changes in the eyes caused by diabetes can help predict which people are more likely to experience worsening diabetic retinopathy (a diabetes-related eye disease) and how these eye changes are related to cardiovascular complications.\n\nThe study will include about 1,000 people with type 2 diabetes, aged 35 to 90 years, and will take place over twelve months. It may also include a retrospective component, where existing medical and imaging data collected from previous visits (within the last 1 to 5 years) will be analyzed.\n\nThe main questions it aims to answer are:\n\n* Can eye vessel and tissue changes, observed through modern imaging techniques and clinical data, help better describe and predict which cases of diabetic retinopathy will become more severe?\n* Can these same eye changes help predict the presence and risk of cardiovascular problems-such as heart disease or stroke-in people living with type 2 diabetes?",[29],"2026-02-27",{"date":450,"type":37},"2026-03-02",{"date":452,"type":37},"2025-11-03",{"date":454,"type":22},"2027-11",{"name":436,"class":149},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":23,"phases":466,"briefSummary":467,"conditions":468,"keywords":476,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":108},"100525657","early-percutaneous-transluminal-angioplasty-in-diabetic-foot-syndrome-pta-dfs-100525657","NCT06124586","Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)","Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome","PTA-DFS","Inclusion Criteria:\n\n* volunteer adults\n* written informed consent\n* presence of known manifest T2D and fulfilment of the following criteria:\n* HbA1c \\\u003C 10%\n* presence of pAVD with fulfillment of the following criteria:\n* PAD Stage After Fontaine IV (foot ulcer)\n* Presence of foot ulcer with fulfillment of the following criteria:\n* Foot ulceration without indication for emergency surgical care from stage Wagner 1.\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock).\n* Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive).\n* Minors or subjects incapable of giving consent\n* Pregnant or breastfeeding women\n* Treatment with certain drugs (immunosuppressive therapy,\n* Immunomodulators, chemotherapy, antibiotic therapy \\\u003C 2 weeks before\n* intervention)\n* Diseases of the pancreas\n* Severe neurological or psychiatric disease\n* Known presence of malignant tumor disease within the past 5 years\n* Participation in other interventional trials and receipt of investigational medication within the last 30 days\n* Blood or plasma donation within the last 3 months",{"count":465,"type":22},200,[162],"The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness (\"immediate\" treatment, within 48h) has advantages over the \"standard of care\", i.e., an elective procedure (\"elective PTA\") for the treatment of diabetic foot ulcer (DFU). The primary study endpoint is to investigate the impact of the \"early PTA\" within 48 hours on wound-healing assessed by wound area changes after PTA using a 3D-camera with artificial intelligence (AI)-based wound-analysis-system. The secondary endpoint is the effect of early PTA on the combined occurrence of major adverse limb (MALE) and cardiac events (MACE) over 12 months post-angioplasty using time-to-event analysis. Data will be collected at baseline, 24 hours, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography will be assessed. Explanatory variables for wound healing are wound microbiome changes using whole-genome sequencing and oxygen saturation of the wound environment measured using near-infrared spectroscopy. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.",[469,290,470,471,29,472,473,474,475],"Diabetic Foot","Peripheral Arterial Disease","Diabetic Neuropathies","Anemia","Ulcer Foot","Ulcer Ischemic","Diabetic Polyneuropathy",[477,478,479,480,481],"diabetic foot syndrome","peripheral artery disease","diabetic food ulcers","microbiome","percutaneous transluminal angioplasty","2026-02-03",{"date":484,"type":37},"2026-02-04",{"date":486,"type":37},"2024-02-01",{"date":488,"type":22},"2028-11-01",{"name":490,"class":149},"Heinrich-Heine University, Duesseldorf",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":502,"conditions":503,"keywords":506,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":108},"100363123","early-phase-1-feasibility-and-safety-of-mb-102-in-ocular-angiography-as-compared-to-fluorescein-sodium-100363123","NCT04008121","Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium","A Pilot Study to Assess the Feasibility and Safety of MB-102 in Ocular Angiography as Compared to Fluorescein Sodium","Inclusion Criteria:\n\n* Age \\> 18 years - male or female\n\n  1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to utilize adequate contraception during the trial\n  2. Males must be willing to practice abstinence or utilize adequate contraception from MB-102 dosing day to at least 7 days post dose\n* Participants willing to comply with study requirements\n* Participants who have signed an informed consent form\n\nAt least 5 participants will have a current history of retinal or choroidal vascular diseases.\n\nExclusion Criteria:\n\n* Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to utilize adequate contraception\n* Participation in another interventional trial within 30 days of treatment or concurrently enrolled in any other medical research study which could impact the results of the study\n* History of drug or alcohol abuse within the past year\n* History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 and fluorescein sodium or other related products (intolerance to a drug is not considered a drug allergy).\n* Prior history of seizures\n* Current visually significant cataracts or other ophthalmic conditions that would limit appropriate collection of fundus photographs\n* Site personnel immediately associated with the study or their immediate family members\n* Unable to tolerate ophthalmologic imaging\n* Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial (e.g. unstable medical condition including cardiovascular disease, or other conditions considered clinically significant or unstable by the Principal Investigator)\n* Prior enrollment and dosing in this study",{"count":499,"type":22},10,[501],"EARLY_PHASE1","The objective of this study is to evaluate the safety and image quality of the investigational dye, MB-102, compared to the control dye (fluorescein sodium) in healthy and diseased eyes using fluorescent angiography for retinal vascular disease diagnosis and monitoring.",[504,92,29,505],"Retinopathy","Macular Degeneration",[507],"Fluorescein angiography","2026-02-02",{"date":484,"type":37},{"date":511,"type":37},"2025-11-06",{"date":513,"type":22},"2026-12",{"name":515,"class":44},"MediBeacon",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":81,"sex":17,"minAge":523,"maxAge":524,"enrollmentInfo":525,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":527,"conditions":528,"keywords":530,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":108},"100316754","human-ipsc-for-repair-of-vasodegenerative-vessels-in-diabetic-retinopathy-100316754","NCT03403699","Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy","iPSC","Inclusion Criteria:\n\n* Any man or woman between the ages of 21- 98 years of age will be eligible to participate. To participate in the study as a study subject we will require: a) the subject must either carry the diagnosis of diabetes or be a healthy aged control and b) the patient be willing and have the ability to cooperate with the eye exam and skin punch biopsy protocol.\n\nExclusion Criteria:\n\n* We will apply the following exclusion criteria: a) evidence of ongoing acute or chronic infection (HIV, Hepatitis B or C, tuberculosis); b) ongoing malignancy; c) cerebral vascular accident or cerebral vascular procedure; d) current pregnancy; e) history of organ transplantation; f) presence of a graft (to avoid any effect of the graft on inflammatory parameters; and g) patients with anemia. Subjects with AMD, glaucoma, uveitis, known hereditary degenerations or other significant ocular complications other than diabetic retinopathy will be excluded.","21 Years","98 Years",{"count":526,"type":22},20,"This study proposes to carefully examine the hypothesis that human inducible pluripotent stem cells (iPSCs) can be effectively employed as a future therapeutic option for individuals with diabetic retinopathy and macular ischemia. iPSCs will be generated from the peripheral blood cells of subjects with diabetes and age matched controls. The human iPSC cells will be used to generate mesoderm cells for injection into the vitreous cavity of diabetic rodents and primate eyes. The ability of mesoderm cells to generate endothelial cells and pericytes in areas of degenerated capillaries will be examined. The human iPSCs will also be used to generate hematopoietic CD34+CD45+ cells. The combination of CD34+CD45+ cells derived from iPSCs and iPSC derived mesoderm will be examined in combination for their potentially beneficial effect to enhance the vessel formation.",[529,29],"Diabetes Complications",[531],"inducible pluripotent stem cells","2026-01-20",{"date":534,"type":37},"2026-01-22",{"date":536,"type":37},"2018-01-11",{"date":538,"type":22},"2027-12-31",{"name":540,"class":149},"University of Alabama at Birmingham",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":4,"eligibilityCriteria":547,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":23,"phases":550,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":219,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":108},"100618964","high-resolution-imaging-oct-study-100618964","NCT07338461","High Resolution Imaging OCT Study","High Resolution Imaging OCT Pilot Study","Inclusion Criteria:\n\n* All Able and willing to undergo the test procedures, give consent, and to follow instructions.\n\nSigned informed consent Age ≥ 18 years\n\n* Healthy Subjects without uncontrolled systemic conditions, as determined by the investigator Subjects without ocular disease, as determined by the investigator Corrected visual acuity ≥ 20\u002F40 No reported history of ocular surgical intervention (except for refractive or cataract surgery)\n* Age-related macular degeneration Subjects with a diagnosis of AMD as determined by the investigator, either early-intermediate, atrophic, or neovascular\n* Diabetic retinopathy Subjects with a diagnosis of diabetic retinopathy as determined by the investigator\n* Disease with expected altered autofluorescence pattern Subjects with a disease that can be expected to be associated with altered autofluorescence patterns as determined by the investigator\n\nExclusion Criteria:\n\n* Subjects unable to read or write\n* Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging\n* Subjects who cannot tolerate the imaging procedures\n* History of photosensitive epilepsy\n* Vulnerable subjects, i.e., individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.",{"count":549,"type":22},97,[162],"The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and\u002For pathology eyes.\n\nParticipants will be imaged with different imaging modalities and scan protocols on all study devices.",[553,263,29,554],"Normal Eyes","Eyes With Retinal Diseases","2026-01-13",{"date":557,"type":37},"2026-01-15",{"date":559,"type":22},"2026-01-12",{"date":561,"type":22},"2027-02-28",{"name":563,"class":44},"Heidelberg Engineering GmbH",{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":81,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":573,"conditions":574,"keywords":588,"overallStatus":219,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"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",{"count":465,"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.",[575,28,29,576,577,578,579,580,581,582,583,584,585,586,587,92],"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",[589,590,591,592,593,594],"wide-field octa","multimodal retinal imaging","quantitative imaging","retinal disease","macular disease","ocular surface disease","2025-12-22",{"date":597,"type":37},"2025-12-30",{"date":599,"type":22},"2026-01",{"date":601,"type":22},"2028-05",{"name":603,"class":149},"IRCCS San Raffaele",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":23,"phases":614,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":627,"locationsCount":108},"100611153","artificial-intelligence-for-diagnosing-diabetic-retinopathy-in-primary-care-100611153","NCT07236879","Artificial Intelligence for Diagnosing Diabetic Retinopathy in Primary Care","Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes","AID-DR","Inclusion Criteria:\n\n* Adults (\\> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.\n\nExclusion Criteria:\n\n* Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy).\n* Life expectancy less than 6 months",{"count":613,"type":22},922,[162],"This is a clinical trial to evaluate the effects of universal screening for diabetic retinopathy (DR) and diabetic macular edema (DME) using artificial intelligence (AI) in the interpretation of fundus photographs obtained by trained nursing assistant using a portable fundus camera in a primary care setting, compared with images obtained by the same method, but interpreted by ophthalmologists.",[29],[618,619,620],"screening","diabetic retinopathy","artificial intelligence","2025-11-17",{"date":623,"type":37},"2025-11-19",{"date":625,"type":37},"2024-08-08",{"date":513,"type":22},{"name":628,"class":149},"Hospital de Clinicas de Porto Alegre",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":23,"phases":639,"briefSummary":640,"conditions":641,"keywords":645,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":659,"startDateStruct":661,"completionDateStruct":662,"leadSponsor":664,"locationsCount":108},"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":638,"type":22},40,[162],"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.",[642,29,643,28,644,424],"Proliferative Diabetic Retinopathy","Diabetic Retinopathy Visually Threatening","Diabetes Mellitus, Type 1",[646,647,648,649,650,651,652,653,654,655,656,657,658],"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":660,"type":37},"2025-11-18",{"date":363,"type":37},{"date":663,"type":22},"2030-12-31",{"name":665,"class":666},"Vastra Gotaland Region","OTHER_GOV"]