[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553958":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":55,"collaborators":23,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":23,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":23,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Frontera Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FT-002 dose 1","EXPERIMENTAL","Low dose FT-002",[13],"Genetic: FT-002",{"label":15,"type":10,"description":15,"interventionNames":16},"High dose FT-002",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"GENETIC","FT-002","Intraocular injection of a single dose",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"Ruifang Sui","Peking Union Medical College Hospital","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":23,"email":34},"Xinyan Li","CONTACT","+86-021-58206061","xinyan.li@fronteratherapeutics.com",{"name":36,"role":32,"phone":33,"phoneExt":23,"email":37},"Minghui Xue","minghui.xue@fronteratherapeutics.com",[39],{"facility":27,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Beijing","Beijing Municipality","100142","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":23,"phoneExt":23,"email":23},"Ruifang Sui, Professor",{"type":56,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100553958","phase-1-gene-therapy-for-rpgr-gene-mutation-associated-x-linked-retinitis-pigmentosa-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":68,"type":69},32,"ESTIMATED","INTERVENTIONAL",[72,73],"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).",[76],"X-Linked Retinitis Pigmentosa (XLRP)",[76,20],"2024-07-01",{"date":80,"type":81},"2024-07-09","ACTUAL",{"date":83,"type":81},"2024-04-01",{"date":85,"type":69},"2026-02-01",{"name":5,"class":6},1]