[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Youxin Chen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"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":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100532456","phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-skg0106-in-patients-with-neovascular-age-related-macular-degeneration-namd-100532456",false,"NCT06213038","A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)","An Open-label, Dose-escalation Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Characteristics of SKG0106 Intraocular Solution After Single Intravitreal Injection in Chinese Patients With Neovascular (Wet) Age-related Macular Degeneration","Inclusion Criteria:\n\n1. Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;\n2. Aged ≥ 50 years at screening;\n\n   Study Eye:\n3. Diagnosis of nAMD as determined by the PI;\n4. Active CNV lesions secondary to age-related macular degeneration (AMD);\n5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment\n\nExclusion Criteria:\n\n1. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;\n2. Retinal pigment epithelial tear in the study eye at screening;\n3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;\n4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;\n5. History of retinal detachment or active retinal detachment in the study eye;\n6. Any prior gene therapy.","ALL","50 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.",[26],"Neovascular Age-related Macular Degeneration",[28,29,30,31],"AMD","wet AMD","wAMD","nAMD","RECRUITING","2025-01-06",{"date":35,"type":36},"2025-01-08","ACTUAL",{"date":38,"type":36},"2023-05-05",{"date":40,"type":20},"2025-05-30",{"name":42,"class":43},"Youxin Chen","OTHER",3,""]