[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500905":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":145,"collaborators":32,"id":147,"slug":32,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":154,"sex":155,"minAge":156,"maxAge":32,"enrollmentInfo":157,"targetDuration":32,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":49,"whyStopped":32,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Ocugen","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","3+3 participants will receive intravitreal injection of OCU200 (0.5 mg\u002FmL concentration).",[13],"Drug: OCU200",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","3+3 participants will receive intravitreal injection of OCU200 (1 mg\u002FML concentration).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","3+3 participants will receive intravitreal injection of OCU200 (2 mg\u002FmL concentration).",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4","3+3 participants will receive intravitreal injection of OCU200 (5 mg\u002FmL concentration).",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","OCU200","Intravitreal Injection",[9,15,19,23],null,[34],{"name":35,"affiliation":5,"role":36},"Huma Qamar, MD, MPH, CMI","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Roshan A George, MD, MPH","CONTACT","845-664-1505","roshan.george@ocugen.com",{"name":44,"role":40,"phone":32,"phoneExt":32,"email":45},"Oscar Cuzzani, MD, PhD","Oscar.Cuzzani@ocugen.com",[47,72,89,106,125],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Advanced Research LLC","RECRUITING","Deerfield Beach","Florida","33064","United States",{"type":55,"coordinates":56},"Point",[57,58],-80.09977,26.31841,{"lat":58,"lon":57},[61,66,69],{"name":62,"role":40,"phone":63,"phoneExt":64,"email":65},"Danahe Navarrete","954-302-3047","103","dnavarrete@advancedresearchfl.com",{"name":67,"role":40,"phone":32,"phoneExt":32,"email":68},"Samarth Shah, MD, Ph.D","sshah@advancedresearchfl.com",{"name":70,"role":71,"phone":32,"phoneExt":32,"email":32},"Shailesh Gupta, MD","PRINCIPAL_INVESTIGATOR",{"facility":73,"status":49,"city":74,"state":75,"zip":76,"country":53,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Erie Retina Research, LLC","Erie","Pennsylvania","16507",{"type":55,"coordinates":78},[79,80],-80.08506,42.12922,{"lat":80,"lon":79},[83,87],{"name":84,"role":40,"phone":85,"phoneExt":32,"email":86},"Bethany Scott","814-737-0203","b.scott.research@pm.me",{"name":88,"role":71,"phone":32,"phoneExt":32,"email":32},"David Almeida, MD, MDA, PhD",{"facility":90,"status":49,"city":91,"state":92,"zip":93,"country":53,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Retina Consultants of Texas Research Centers","Bellaire","Texas","77401",{"type":55,"coordinates":95},[96,97],-95.45883,29.70579,{"lat":97,"lon":96},[100,104],{"name":101,"role":40,"phone":102,"phoneExt":32,"email":103},"Rebecca Taing","713-394-7576","rebbecca.taing@retinaconsultantstexas.com",{"name":105,"role":71,"phone":32,"phoneExt":32,"email":32},"Charles Wykoff, MD",{"facility":107,"status":49,"city":108,"state":92,"zip":109,"country":53,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Retina Consultants of America","Southlake","76092",{"type":55,"coordinates":111},[112,113],-97.13418,32.94124,{"lat":113,"lon":112},[116,120,123],{"name":117,"role":40,"phone":118,"phoneExt":32,"email":119},"Lydia Adams","800-833-5921","lydia.adams@retinaconsultantstexas.com",{"name":121,"role":40,"phone":32,"phoneExt":32,"email":122},"Emily Gonzales","emily.gonzales@retinaconsultantstexas.com",{"name":124,"role":71,"phone":32,"phoneExt":32,"email":32},"R.Gary Lane, MD",{"facility":126,"status":49,"city":127,"state":128,"zip":129,"country":53,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Gundersen Health System","La Crosse","Wisconsin","54601",{"type":55,"coordinates":131},[132,133],-91.23958,43.80136,{"lat":133,"lon":132},[136,140,143],{"name":137,"role":40,"phone":138,"phoneExt":32,"email":139},"Trinity Lee","608-775-9539","trinity.lee@emplifyhealth.org",{"name":141,"role":40,"phone":32,"phoneExt":32,"email":142},"Chase Penzkover","chase.penzkover@emplifyhealth.org",{"name":144,"role":71,"phone":32,"phoneExt":32,"email":32},"Syed M Shah, MD",{"type":146,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":158,"type":159},24,"ESTIMATED","INTERVENTIONAL",[162],"PHASE1","A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema",[165,166],"Center Involved Diabetic Macular Edema","Diabetic Macular Edema",[168,169,170,152],"anti-VEGF","Transferrin","Tumstatin","2025-11-25",{"date":173,"type":174},"2025-12-03","ACTUAL",{"date":176,"type":174},"2024-01-13",{"date":178,"type":159},"2026-07-31",{"name":5,"class":6},5]