[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inherited-retinal-disease-ird\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inherited-retinal-disease-ird":31},{"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":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100576757","phase-1-a-study-to-investigate-the-safety-of-opct-001-in-adults-who-have-primary-photoreceptor-disease-clarico-100576757",false,"NCT06789445","A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)","A Phase 1\u002F2a Study of Subretinal Administration of OpCT-001 Photoreceptor Precursor Cells Derived From iPSCs in Patients With Primary Photoreceptor Disease","CLARICO","Key Inclusion Criteria:\n\n* Confirmed genetic diagnosis of primary photoreceptor (PR) disease\n* Best corrected visual acuity (BCVA) in the study eye at Screening for Phase 1: Logmarithm of the minimum angle of resolution (LogMAR) 3.9 to LogMAR 1.3. BCVA at Screening for Phase 2: ETDRS letter score between 20 to 60, inclusive.\n* Retinal structure examination in the study eye demonstrating regions suitable for cell administration.\n\nKey Exclusion Criteria:\n\n* Clinically relevant, active ocular inflammation or infection\n* Glaucoma or other significant optic neuropathy\n* Diabetic macular edema or diabetic retinopathy\n* Clinically significant cystoid macular edema\n* In phakic participants: Spherical equivalent refractive error of greater than 8.00 diopters myopia\n* Ocular surgery ≤3 months before Screening\n* Monocular vision (ie, no light perception in the fellow eye)\n* Currently active malignancy, or history of malignancy within 5 years before OpCT-001 administration. Exception: Basal cell carcinoma that has been definitively treated.\n* Any current and active infection (bacterial\u002Fviral\u002Ffungal) that could put the participant at risk from immunosuppression\n* History of any cell therapy, gene therapy, or retinal implant at any time\n* Previously received a bone marrow or solid organ transplant","ALL","18 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Study OpCT-001-101 is a Phase 1\u002F2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in approximately 54 adults with primary photoreceptor (PR) disease. Phase 1 focuses on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups.",[28,29,30,31,32,33,34,35,36],"Primary Photoreceptor Disease","Retinitis Pigmentosa (RP)","Usher Syndrome","Inherited Retinal Disease (IRD)","Rod-Cone Dystrophy","Rod-Cone Disease","Retinal Degeneration","Cone-Rod Disease (C-RD)","Cone-Rod Dystrophy",[15,38,39,40,30,41,42,43,44,45],"Photoreceptor cells","Cell Therapy","Cellular Therapy","Retinitis Pigmentosa","Inherited retinal disease (IRD)","Primary Photoreceptor disease (PPD)","Rod-Con Disease (R-CD)","Cone-Rose disease (C-RD)","RECRUITING","2026-04-07",{"date":49,"type":50},"2026-04-13","ACTUAL",{"date":52,"type":50},"2025-03-10",{"date":54,"type":21},"2030-10",{"name":56,"class":57},"BlueRock Therapeutics","INDUSTRY",4]