[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620846":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":27,"locations":33,"responsibleParty":62,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":26,"overallStatus":36,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"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",[34,50],{"facility":35,"status":36,"city":37,"state":26,"zip":26,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Shanghai General Hospital","RECRUITING","Shanghai","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47,48],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},{"name":29,"role":49,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":51,"status":52,"city":37,"state":26,"zip":26,"country":38,"countryCode":39,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"Zhongshan Hospital","NOT_YET_RECRUITING",{"type":41,"coordinates":54},[43,44],{"lat":44,"lon":43},[57,61],{"name":58,"role":30,"phone":59,"phoneExt":26,"email":60},"Yuanzhi Yuan","+86 02164041990","Yuan.yuanzhi@zs-hospital.sh.cn",{"name":58,"role":49,"phone":26,"phoneExt":26,"email":26},{"type":49,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Xiaodong Sun","Professor",[66],{"name":67,"class":68},"Innostellar Biotherapeutics Co.,Ltd","INDUSTRY","100620846","early-phase-1-safety-and-efficacy-evaluation-of-lx111-gene-therapy-in-dme-patients-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":79,"type":80},32,"ESTIMATED","INTERVENTIONAL",[83],"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.",[86],"Diabetic Macular Edema (DME)","2026-03-09",{"date":89,"type":90},"2026-03-10","ACTUAL",{"date":92,"type":80},"2026-03",{"date":94,"type":80},"2031-09",{"name":5,"class":6},2]