[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553958":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":24,"interventions":34,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":71,"collaborators":17,"id":73,"slug":17,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":17,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":17,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":56,"whyStopped":17,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Frontera Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the safety and tolerance of FT-002","Incidence and severity of AEs","from FT-002 administration through up to 1 years",[14],{"measure":15,"description":16,"timeFrame":12},"To evaluate the efficacy of FT-002","Changes in visual sensitivity \u002FFST\u002FBCVAfrom baseline",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE",[25,31],{"label":26,"type":27,"description":28,"interventionNames":29},"FT-002 dose 1","EXPERIMENTAL","Low dose FT-002",[30],"Genetic: FT-002",{"label":32,"type":27,"description":32,"interventionNames":33},"High dose FT-002",[30],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":17},"GENETIC","FT-002","Intraocular injection of a single dose",[26,32],[41],{"name":42,"affiliation":43,"role":44},"Ruifang Sui","Peking Union Medical College Hospital","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":17,"email":50},"Xinyan Li","CONTACT","+86-021-58206061","xinyan.li@fronteratherapeutics.com",{"name":52,"role":48,"phone":49,"phoneExt":17,"email":53},"Minghui Xue","minghui.xue@fronteratherapeutics.com",[55],{"facility":43,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":63,"coordinates":64},"Point",[65,66],116.39723,39.9075,{"lat":66,"lon":65},[69],{"name":70,"role":48,"phone":17,"phoneExt":17,"email":17},"Ruifang Sui, Professor",{"type":72,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100553958",false,"NCT06492850","Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa","A Phase I\u002FII Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of FT-002 Subretinal Injection in Subjects With RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa.","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign a written informed consent form;\n* Age: Phase I dose escalation stage, 18-45 years old male (including boundary value) at the time of signing the ICF; Phase II dose extension stage, males 8-45 years old (including boundary values) at the time of signing the ICF;\n* Clinically diagnosed XLRP, the main symptoms include but are not limited to night blindness, visual field loss, vision loss, etc.;\n\nExclusion Criteria:\n\n* Have other retinal degenerative diseases, such as retinal degeneration caused by other known Inherited retinal disease gene variants or previously received an gene therapy product.","MALE","8 Years","45 Years",{"count":83,"type":84},32,"ESTIMATED","INTERVENTIONAL",[87,88],"PHASE1","PHASE2","The aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of FT-002 in male subjects (8-45 years of age) with RPGR (Retinitis Pigmentosa GTPase Regulator) gene mutation-associated X-linked retinitis pigmentosa, of XLRP. This study includes Phase I (dose escalation phase) and Phase II (dose expansion phase).",[91],"X-Linked Retinitis Pigmentosa (XLRP)",[91,37],"2024-07-01",{"date":95,"type":96},"2024-07-09","ACTUAL",{"date":98,"type":96},"2024-04-01",{"date":100,"type":84},"2026-02-01",{"name":5,"class":6},1]