[{"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":28},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100637306","phase-1-a-safety-study-of-contralateral-eye-dosing-of-vgr-r01-in-participants-with-biettis-crystalline-dystrophy-bcd-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":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"Bietti Crystalline Dystrophy",[30,31,32],"VGR-R01","CYP4V2","gene therapy","NOT_YET_RECRUITING","2026-05-12",{"date":36,"type":37},"2026-05-14","ACTUAL",{"date":39,"type":21},"2026-06-01",{"date":41,"type":21},"2031-07-31",{"name":43,"class":44},"Shanghai Vitalgen BioPharma Co., Ltd.","INDUSTRY",2]