[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637306":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":57,"collaborators":20,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":20,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Shanghai Vitalgen BioPharma Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VGR-R01 group","EXPERIMENTAL","Single-dose Subretinal Administration of VGR-R01",[13],"Biological: VGR-R01",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","VGR-R01","CYP4v2-coding gene delivered by AAV vector",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Wenbin Wei","Beijing Tongren Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Yan Jiang","CONTACT","086-15802234907","yan.jiang@vitalgen.com",[33,46],{"facility":24,"status":20,"city":34,"state":35,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Beijing","Beijing Municipality","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.39723,39.9075,{"lat":42,"lon":41},[45],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"facility":47,"status":20,"city":48,"state":49,"zip":20,"country":36,"countryCode":37,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Shanghai General Hospital (Shanghai First People's Hospital)","Shanghai","Shanghai Municipality",{"type":39,"coordinates":51},[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},{"type":58,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":70,"type":71},15,"ESTIMATED","INTERVENTIONAL",[74,75],"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.",[78],"Bietti Crystalline Dystrophy",[17,80,81],"CYP4V2","gene therapy","NOT_YET_RECRUITING","2026-05-12",{"date":85,"type":86},"2026-05-14","ACTUAL",{"date":88,"type":71},"2026-06-01",{"date":90,"type":71},"2031-07-31",{"name":5,"class":6},2]