[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biallelic-rpe65-mutation-associated-retinal-dystrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biallelic-rpe65-mutation-associated-retinal-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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100505255","phase-1-gene-therapy-in-subjects-with-biallelic-rpe65-mutation-associated-retinal-dystrophy-100505255",false,"NCT05858983","Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy","A Multi-center, Open-label, Dose-escalation Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability and Efficacy of FT-001 Administered Via Subretinal Injection in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy","Inclusion Criteria:\n\n1. Subjects who are able to understand and sign the ICF\n2. Female or male aged 8-45 years old when signing the ICF\n3. Clinically diagnosed with biallelic RPE65 mutation-associated retinal dystrophy\n\nExclusion Criteria:\n\n1. Other interfering eye diseases\n2. Presence of any systemic or ocular disease that can cause or likely to cause vision loss\n3. There is evidence of obviously uncontrolled concomitant diseases\n4. Known to have active or suspected autoimmune diseases\n5. With active systemic infection under treatment\n6. Pregnant or lactating women\n7. Other conditions unsuitable for the study as determined by the investigator","ALL","8 Years","45 Years",{"count":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of subretinal administration of FT-001 in subjects with biallelic RPE65 mutation-associated retinal dystrophy.",[28],"Biallelic RPE65 Mutation-associated Retinal Dystrophy",[30,28],"FT-001","RECRUITING","2023-05-11",{"date":34,"type":35},"2023-05-15","ACTUAL",{"date":37,"type":35},"2022-11-30",{"date":39,"type":21},"2029-11-30",{"name":41,"class":42},"Frontera Therapeutics","INDUSTRY"]