[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bietti-crystalline-dystrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bietti-crystalline-dystrophy":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100637306",false,"NCT07586306","A Safety Study of Contralateral Eye Dosing of VGR-R01 in Participants With Bietti's Crystalline Dystrophy (BCD)","A Clinical Study Evaluating Subretinal Injection of VGR-R01 in the Contralateral Eye of Participants With Bietti's Crystalline Dystrophy Who Had Received VGR-R01 Administration","Key Inclusion Criteria:\n\n1. Participants received VGR-R01 administration in the VGR-R01-001 or VGR-R01-101 studies.\n2. Able to provide informed consent and comply with requirements of the study;\n3. Hand Motion ≤ BCVA ≤ 75 ETDRS letters in the second treated eye.\n\nKey Exclusion Criteria:\n\n1. Have insufficient viable retinal photoreceptor cells based on investigator's decision;\n2. Have current ocular or periocular infections, or endophthalmitis;\n3. Have any significant ocular disease\u002Fdisorder other than BCD, including age-related macular degeneration, diabetic retinopathy, optic neuropathy, significant lens opacity, glaucoma, uveitis, retinal detachment, etc;\n4. Have intraocular surgery history except cataract surgery in the study eye;\n5. Have or potentially require of systemic medications that may cause eye injure;\n6. Have contraindications for corticosteroids or immunosuppressant;\n7. Abnormal coagulation function or other clinically significant abnormal laboratory results;\n8. Have malignancies or history of malignancies;\n9. History of immunodeficiency (acquired or congenital); Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","69 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multi-centre, single- arm, non-randomized, open-label phase 1\u002F2 clinical trial which enables dosing of the fellow eyes of patients who received VGR-R01 administration in previous studies.",[27],"Bietti Crystalline Dystrophy",[29,30,31],"VGR-R01","CYP4V2","gene therapy","NOT_YET_RECRUITING","2026-05-12",{"date":35,"type":36},"2026-05-14","ACTUAL",{"date":38,"type":20},"2026-06-01",{"date":40,"type":20},"2031-07-31",{"name":42,"class":43},"Shanghai Vitalgen BioPharma Co., Ltd.","INDUSTRY",2,""]