[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620846":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":27,"locations":33,"responsibleParty":61,"collaborators":64,"id":68,"slug":26,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":26,"overallStatus":36,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"LX111 Dose Escalation up to 2 dose levels","EXPERIMENTAL","Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.",[13],"Genetic: LX111 Injection",{"label":15,"type":10,"description":11,"interventionNames":16},"LX111 Dose Expansion Dose 1",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"LX111 Dose Expansion Dose 2",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"GENETIC","LX111 Injection","LX111 is an rAAV gene therapy vector carrying a coding sequence for VEGF-trap.",[9,15,18],null,[28],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Li Su","CONTACT","+86 02136126254","li.su@shgh.cn",[34,49],{"facility":35,"status":36,"city":37,"state":26,"zip":26,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Shanghai General Hospital","RECRUITING","Shanghai","China",{"type":40,"coordinates":41},"Point",[42,43],121.45806,31.22222,{"lat":43,"lon":42},[46,47],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},{"name":29,"role":48,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":50,"status":51,"city":37,"state":26,"zip":26,"country":38,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Zhongshan Hospital","NOT_YET_RECRUITING",{"type":40,"coordinates":53},[42,43],{"lat":43,"lon":42},[56,60],{"name":57,"role":30,"phone":58,"phoneExt":26,"email":59},"Yuanzhi Yuan","+86 02164041990","Yuan.yuanzhi@zs-hospital.sh.cn",{"name":57,"role":48,"phone":26,"phoneExt":26,"email":26},{"type":48,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Xiaodong Sun","Professor",[65],{"name":66,"class":67},"Innostellar Biotherapeutics Co.,Ltd","INDUSTRY","100620846",false,"NCT07362927","Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients","An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Diabetic Macular Edema (DME)","Inclusion Criteria:\n\n1. Willing to sign the informed consent, and willing to attend follow-up visits;\n2. Age ≥ 18;\n3. Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea;\n4. CST ≥ 300 μm in the study eye at Screening;\n5. BCVA ETDRS letters between 19 and 73;\n6. Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response;\n7. Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.\n\nExclusion Criteria:\n\n1. Active proliferative diabetic retinopathy (PDR);\n2. Presence of iris neovascularization in the study eye at Screening;\n3. Retinal laser photocoagulation in the study eye within 3 months prior to Screening;\n4. Prior gene therapy in the study eye;\n5. The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening.\n6. Systemic anti-VEGF treatment within 3 months before Screening;\n7. Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to Screening;","ALL","18 Years",{"count":77,"type":78},32,"ESTIMATED","INTERVENTIONAL",[81],"EARLY_PHASE1","The goal of this study is to evaluate the safety and efficacy of LX111 treatment of DME. This study will enroll participants aged ≥ 18 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.",[84],"Diabetic Macular Edema (DME)","2026-03-09",{"date":87,"type":88},"2026-03-10","ACTUAL",{"date":90,"type":78},"2026-03",{"date":92,"type":78},"2031-09",{"name":5,"class":6},2]