[{"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:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100500905","phase-1-phase-i-study-to-assess-the-safety-and-efficacy-of-ocu200-for-center-involved-diabetic-macular-edema-dme-100500905",false,"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,"ALL","18 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema",[28,29],"Center Involved Diabetic Macular Edema","Diabetic Macular Edema",[31,32,33,15],"anti-VEGF","Transferrin","Tumstatin","RECRUITING","2025-11-25",{"date":37,"type":38},"2025-12-03","ACTUAL",{"date":40,"type":38},"2024-01-13",{"date":42,"type":22},"2026-07-31",{"name":44,"class":45},"Ocugen","INDUSTRY",5,""]