[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Skyline Therapeutics (US) Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"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":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100515081","phase-1-phase-iii-study-of-skg0106-intravitreal-injection-in-patients-with-neovascular-age-related-macular-degeneration-namd-100515081",false,"NCT05986864","Phase I\u002FII Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)","Phase I\u002FII Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)","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},68,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a phase 1\u002F2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.",[27],"Neovascular Age-related Macular Degeneration",[29,30,31,32],"AMD","wet AMD","wAMD","nAMD","RECRUITING","2025-01-08",{"date":36,"type":37},"2025-01-09","ACTUAL",{"date":39,"type":37},"2024-02-23",{"date":41,"type":20},"2026-01-30",{"name":43,"class":44},"Skyline Therapeutics (US) Inc.","INDUSTRY",9,""]