[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501876":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":43,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LX103 Injection","EXPERIMENTAL","Potential doses:\n\n5E10 vg, 0.1 mL\u002Feye\u002Fdose (low dose)\n\n1E11 vg, 0.05 mL\u002Feye\u002Fdose (high dose)",[13],"Genetic: LX103 Injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"GENETIC","Qualified subjects will receive a single unilateral intravitreal injection of LX103 at Day 0 in the trial.",[9],null,[21],{"facility":22,"status":23,"city":24,"state":19,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Shanghai General Hospital, Shanghai Jiao Tong University","RECRUITING","Shanghai","200080","China","CN",{"type":29,"coordinates":30},"Point",[31,32],121.45806,31.22222,{"lat":32,"lon":31},[35,40],{"name":36,"role":37,"phone":38,"phoneExt":19,"email":39},"Junran Sun, MD","CONTACT","+86 13661995933","emiliesun@sina.com",{"name":41,"role":42,"phone":19,"phoneExt":19,"email":19},"Xiaodong Sun, PhD","PRINCIPAL_INVESTIGATOR",{"type":42,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Xiaodong Sun","PhD",[47],{"name":48,"class":49},"Innostellar Biotherapeutics","UNKNOWN","100501876","safety-and-efficacy-study-of-lx103-treatment-of-x-linked-retinoschisis-xlrs-100501876",false,"NCT05814952","Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)","An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX103 in Patients With X-Linked Retinoschisis (XLRS)","Inclusion Criteria:\n\n1. Willing to sign the informed consent, and willing to attend follow-up visits.\n2. Male individual at least 6 years of age with a diagnosis of XLRS and documented mutations in the RS1 gene.\n3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.\n\nExclusion Criteria:\n\n1. Any eye with disease that would interfere with the fundus examinations.\n2. The study eye is receiving topical carbonic anhydrase inhibitor, or has received topical carbonic anhydrase inhibitors in the past three months.\n3. The study eye has undergone intraocular surgery within six months prior to enrollment.\n4. Participant has uncontrolled hypertension or diabetes.","MALE","6 Years",{"count":60,"type":61},12,"ESTIMATED","INTERVENTIONAL",[64],"NA","The goal of this study is to evaluate the safety and efficacy of LX103 treatment of X-linked retinoschisis. This study will enroll subjects aged ≥ 6 years old to receive a single unilateral intravitreal (IVT) injection of LX103 to evaluate its safety and efficacy.",[67],"X-linked Retinoschisis","2023-04-04",{"date":70,"type":71},"2023-04-18","ACTUAL",{"date":73,"type":71},"2022-12-13",{"date":75,"type":61},"2028-08",{"name":5,"class":6},1]