[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ocugen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100652284","phase-3-phase-3-study-to-assess-efficacy-safety--tolerability-of-ocu410-for-geographic-atrophy-secondary-to-dry-amd-100652284",false,"NCT07770828","Phase 3 Study to Assess Efficacy, Safety & Tolerability of OCU410 For Geographic Atrophy Secondary to Dry AMD","A Phase 3 Registrational Study To Assess The Efficacy, Safety, And Tolerability Of OCU410 For Geographic Atrophy Secondary To Dry Age-Related Macular Degeneration","Inclusion Criteria:\n\n1. Subjects 55 years of age or older at consent.\n2. BCVA of ≥25 ETDRS letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20\u002F320 Snellen Equivalent) and ≤80 ETDRS Letters (20\u002F25 Snellen Equivalent) in the study eye.\n3. Fundus autofluorescence (FAF) imaging shows: a)Total GA area ≥2.5 and ≤ 17.5 mm2 (1 to 7 disk areas \\[DA\\], respectively); b)If GA is multifocal, at least one lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3a. c)The entire GA lesion must be completely visualized on the macula-centered image and must be able to be imaged in its entirety, and not contiguous with any areas of peripapillary atrophy.\n4. Subjects with history of CNV diagnosis (inactive) in the fellow eye for ≥2 years prior to Screening; stable and treated CNV treatment prior to screening (stable and inactive); no active exudation at screening (confirmed by imaging at the discretion of the investigator)\n5. Subjects who had prior treatment with an approved drug for AMD, e.g. Izervay® (avacincaptad pegol) or Syfovre® (pegcetacoplan injection) can be included, after a washout period of at least 3 months in study eye from screening visit. Subjects can receive an approved drug for AMD in the fellow eye, if required.\n\nExclusion Criteria:\n\n1. Previous treatment with a gene-therapy or cell therapy product.\n2. GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Plaquenil maculopathy. However, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., paving stone degeneration).\n3. Spherical equivalent of the refractive error demonstrating \\> 6 diopters of myopia or an axial length \\>26 mm, inability to fixate, uncontrolled glaucoma, advanced cataract, corneal abnormalities, medium haze, and other retinal pathologies.\n4. Any history or current evidence of exudative (\"wet\") AMD in the study eye including any evidence of retinal pigment epithelium rips, branch retinal artery or vein occlusion, corneal transplant, or evidence of neovascularization anywhere in the retina based on fluorescein angiogram. Subjects with active exudative CNV in the fellow eye will be exclude.\n5. Presence of double-layer sign on SD-OCT, suggestive of subclinical macular neovascularization.","ALL","55 Years",{"count":19,"type":20},237,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study is a Phase 3 multicenter, randomized, controlled, assessor blinded, adaptive study in which subjects will be randomized in a 2:1(OCU410: control) ratio to treatment arm or control arm",[26],"Dry Age-related Macular Degeneration",[28,29],"Geographical Atrophy","Dry Age Related","RECRUITING","2026-08-17",{"date":33,"type":34},"2026-08-19","ACTUAL",{"date":36,"type":34},"2026-08-11",{"date":38,"type":20},"2031-07-30",{"name":40,"class":41},"Ocugen","INDUSTRY",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":71,"locationsCount":72},"100500905","phase-1-phase-i-study-to-assess-the-safety-and-efficacy-of-ocu200-for-center-involved-diabetic-macular-edema-dme-100500905","NCT05802329","Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)","A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema","DME","Inclusion Criteria:\n\n1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus\n2. Decreased visual acuity attributable primarily to DME\n3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:\n\n   1. ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis\n   2. ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus\n4. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart\n5. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging\n6. No history of prior anti-VEGF injection or history of at least 2 consecutive intravitreal anti-VEGF injection (less than 7 weeks apart) with incomplete resolution of CST within 1 year.\n\nNote: The last anti-VEGF injection must be administered at least six weeks (45 days) prior to the study treatment (Day 1) in the study eye.\n\nExclusion Criteria:\n\n1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)\n2. Uncontrolled hypertension\n3. Uncontrolled glaucoma\n4. Concurrent disease in the study eye, other than central-involved DME\n5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit\n6. Any ocular surgery within 3 months prior to the screening visit in the study eye\n7. Uncontrolled\u002Fpoorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)\n8. History of retinal detachment in the study eye or other retinal vascular disease in the study eye\n9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit\n10. Presence of any inherited retinal disease or history of proliferative diabetic retinopathy\n11. History of Renal disease including stage 3b or worse",true,"18 Years",{"count":54,"type":20},24,[56],"PHASE1","A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema",[59,60],"Center Involved Diabetic Macular Edema","Diabetic Macular Edema",[62,63,64,49],"anti-VEGF","Transferrin","Tumstatin","2026-07-30",{"date":67,"type":34},"2026-07-31",{"date":69,"type":34},"2024-01-13",{"date":67,"type":20},{"name":40,"class":41},5,""]