[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532456":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":69,"collaborators":28,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":28,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":28,"enrollmentInfo":81,"targetDuration":28,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":40,"whyStopped":28,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"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",[39,53,64],{"facility":5,"status":40,"city":41,"state":28,"zip":28,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Beijing","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51],{"name":52,"role":35,"phone":28,"phoneExt":28,"email":28},"Youxin Chen",{"facility":54,"status":40,"city":55,"state":28,"zip":28,"country":42,"countryCode":43,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Eye & ENT Hospital of Fudan University","Shanghai",{"type":45,"coordinates":57},[58,59],121.45806,31.22222,{"lat":59,"lon":58},[62],{"name":63,"role":35,"phone":28,"phoneExt":28,"email":28},"Gezhi Xu",{"facility":65,"status":40,"city":55,"state":28,"zip":28,"country":42,"countryCode":43,"cosmosGeoPoint":66,"geoPoint":68,"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":45,"coordinates":67},[58,59],{"lat":59,"lon":58},{"type":70,"investigatorFullName":52,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Professor","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":82,"type":83},12,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.",[89],"Neovascular Age-related Macular Degeneration",[91,92,93,94],"AMD","wet AMD","wAMD","nAMD","2025-01-06",{"date":97,"type":98},"2025-01-08","ACTUAL",{"date":100,"type":98},"2023-05-05",{"date":102,"type":83},"2025-05-30",{"name":52,"class":6},3]