[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616918":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":33,"responsibleParty":50,"collaborators":52,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":24,"enrollmentInfo":63,"targetDuration":24,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":78,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Suzhou UgeneX Therapeutics Co., Ltd.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose of UGX202 group","EXPERIMENTAL","UGX202, 4.2E+10 vg per eye, administered as a single intravitreal injection",[13],"Genetic: UGX202 injection",{"label":15,"type":10,"description":16,"interventionNames":17},"High dose of UGX202 group","UGX202, 1.2E+11 vg\u002Feye, administered as a single intravitreal injection",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"GENETIC","UGX202 injection","Comparison of different dosages of UGX202",[15,9],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Jihong Wu, MD, PHD","CONTACT","+86 21 6437 7134","1217586177@qq.com",{"name":32,"role":28,"phone":29,"phoneExt":24,"email":30},"Xiuqian Yi, MD, PHD",[34],{"facility":35,"status":24,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Eye & ENT Hospital of Fudan University","Shanghai","Shanghai Municipality","200031","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":29,"phoneExt":24,"email":30},"Jihong Wu, MD, Phd",{"type":51,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[53],{"name":35,"class":6},"100616918","early-phase-1-ugx202-injection-in-patients-with-advanced-retinitis-pigmentosa-100616918",false,"NCT07311863","UGX202 Injection in Patients With Advanced Retinitis Pigmentosa","Study to Evaluate the Safety and Preliminary Efficacy of UGX202 Injection in Patients With Advanced Retinitis Pigmentosa","Inclusion Criteria:\n\n* Provide written informed consent form (ICF).\n* Age ≥18 years at ICF signing.\n* Diagnosed as non-syndromic RP；\n* BCVA \\> logMAR 1.9 (assessed by FrACT) in the study eye.\n* Confirmation of preserved memory of visual experience\n* Spherical equivalent between -9D and +6D.\n\nExclusion Criteria:\n\n* Prior gene therapy in either eye.\n* Received any interventional investigational drug within 90 days prior to screening.\n* Any Study eye disease or systemic disease judged by the investigator to affect visual function assessment.\n* Hypersensitivity to corticosteroids, intolerance to corticosteroid regimen, active concurrent infection contraindicating treatment.\n* History or tendency of psychiatric disorders impacting safety and\u002For efficacy assessment.\n* Any other factor deemed unsuitable by the investigator.","ALL","18 Years",{"count":64,"type":65},6,"ESTIMATED","INTERVENTIONAL",[68],"EARLY_PHASE1","The primary objective of this clinical trial is to evaluate the safety and tolerability of a single intravitreal injection of the gene therapy drug UGX202 in patients with advanced RP. The secondary objective is, to assess the preliminary efficacy of a single intravitreal injection of the gene therapy drug UGX202 in treating patients with advanced RP.",[71],"Retinitis Pigmentosa (RP)",[73,74,75,76,77],"UGX202","UGENEXIIT002","retinitis pigmentosa","RP","AAV","NOT_YET_RECRUITING","2025-12-16",{"date":81,"type":82},"2025-12-31","ACTUAL",{"date":84,"type":65},"2026-01",{"date":86,"type":65},"2027-03",{"name":5,"class":6},1]