[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532456":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":68,"collaborators":28,"id":71,"slug":28,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":28,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":28,"enrollmentInfo":79,"targetDuration":28,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":40,"whyStopped":28,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level 1","EXPERIMENTAL","SKG0106 One-Time Intraocular Injection Dose Level 1",[13],"Genetic: SKG0106",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Level 2","SKG0106 One-Time Intraocular Injection Dose Level 2",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose Level 3","SKG0106 One-Time Intraocular Injection Dose Level 3",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"GENETIC","SKG0106","SKG0106 is a recombinant adeno-associated virus (AAV) vector-based in vivo gene therapeutic product",[9,15,19],null,[30],{"name":31,"affiliation":5,"role":32},"Youchen Chen","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":28,"email":37},"CONTACT","13801025972","chenyouxinpumch@163.com",[39,52,63],{"facility":5,"status":40,"city":41,"state":28,"zip":28,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Beijing","China",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":51,"role":35,"phone":28,"phoneExt":28,"email":28},"Youxin Chen",{"facility":53,"status":40,"city":54,"state":28,"zip":28,"country":42,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Eye & ENT Hospital of Fudan University","Shanghai",{"type":44,"coordinates":56},[57,58],121.45806,31.22222,{"lat":58,"lon":57},[61],{"name":62,"role":35,"phone":28,"phoneExt":28,"email":28},"Gezhi Xu",{"facility":64,"status":40,"city":54,"state":28,"zip":28,"country":42,"cosmosGeoPoint":65,"geoPoint":67,"contacts":28},"Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineXin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine",{"type":44,"coordinates":66},[57,58],{"lat":58,"lon":57},{"type":69,"investigatorFullName":51,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Professor","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":80,"type":81},12,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.",[87],"Neovascular Age-related Macular Degeneration",[89,90,91,92],"AMD","wet AMD","wAMD","nAMD","2025-01-06",{"date":95,"type":96},"2025-01-08","ACTUAL",{"date":98,"type":96},"2023-05-05",{"date":100,"type":81},"2025-05-30",{"name":51,"class":6},3]