[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614658":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":45,"locations":11,"responsibleParty":51,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":11},{"fullName":5,"class":6},"Zhongmou Therapeutics","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Low Dose ZM-02","EXPERIMENTAL",null,[13],"Genetic: ZM-02 (low dose)",{"label":15,"type":10,"description":11,"interventionNames":16},"High Dose ZM-02",[17],"Genetic: ZM-02 (high dose)",{"label":19,"type":10,"description":11,"interventionNames":20},"ZM-02 (selected dose)",[21],"Genetic: ZM-02 (selected dose)",{"label":23,"type":24,"description":11,"interventionNames":25},"Sham Comparator","SHAM_COMPARATOR",[26],"Procedure: Sham injection",[28,33,37,40],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"GENETIC","ZM-02 (low dose)","Single unilateral IVT injection of low-dose ZM-02 in the study eye",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"ZM-02 (high dose)","Single unilateral IVT injection of high-dose ZM-02 in the study eye",[15],{"type":29,"name":19,"description":38,"armGroupLabels":39,"otherNames":11},"Single unilateral IVT injection of selected-dose ZM-02 in the study eye",[19],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"PROCEDURE","Sham injection","Sham IVT procedure in the study eye",[23],[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Windy Zhou","CONTACT","+86 18986214263","zmt@zmtherapeutics.com",{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100614658","phase-1-prospective-randomized-sham-controlled-dose-finding-iii-trial-of-safety-and-efficacy-of-modified-optogenetic-gene-therapy-zm-02-injection-100614658",false,"NCT07282457","Prospective, Randomized, Sham-controlled, Dose-finding I\u002FII Trial of Safety and Efficacy of Modified Optogenetic Gene Therapy (ZM-02 Injection)","A Prospective, Randomized, Sham-controlled, Dose-finding Phase 1\u002F2 Two-part Trial to Evaluate the Safety, Tolerability, and Efficacy of ZM-02 Injection in Patients With Advanced Retinitis Pigmentosa","PRISM","Inclusion Criteria\n\n1. Male or female participants aged 6 to 60 years.\n2. Clinical diagnosis of advanced retinitis pigmentosa (RP).\n3. Best corrected visual acuity at or below the protocol-defined threshold in the study eye.\n4. Presence of sufficient retinal structure in the study eye as determined by screening assessments.\n5. Ability to understand and sign informed consent (and assent, when applicable).\n\nExclusion Criteria\n\n1. Presence of other ocular conditions that could interfere with study assessments.\n2. History of significant ocular surgery in the study eye within a protocol-defined period.\n3. Active ocular infection or inflammation.\n4. Clinically significant systemic disease that could increase study risk or interfere with assessments.\n5. Positive screening for clinically significant infectious diseases, as defined in the protocol.\n6. Pregnant or breastfeeding individuals.\n7. Any condition that, in the investigator's judgment, would make the participant unsuitable for study participation.","ALL","6 Years","60 Years",{"count":65,"type":66},21,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","This is a Phase 1\u002F2, multi-center, randomized, sham-controlled, dose-escalation study evaluating ZM-02 in patients with advanced retinitis pigmentosa (RP).",[73],"Retinitis Pigmentosa (RP)",[75,76,77,78],"gene therapy","AAV","RP","optogenetics","NOT_YET_RECRUITING","2026-04-09",{"date":82,"type":83},"2026-04-13","ACTUAL",{"date":85,"type":66},"2026-06-25",{"date":87,"type":66},"2031-12-25",{"name":5,"class":6}]