protocolSection identificationModule nctId: NCT06346600, orgStudyIdInfo id: SKG0106-LF, briefTitle: A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2031-03, completionDateStruct date: 2031-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Skyline Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection., conditionsModule conditions: Neovascular (Wet) Age-related Macular Degeneration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 83, type: ESTIMATED, armsInterventionsModule interventions name: SKG0106, outcomesModule primaryOutcomes measure: Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), secondaryOutcomes measure: Mean change in best corrected visual acuity (BCVA) at each visit from baseline, secondaryOutcomes measure: Mean change in macular central subfield thickness (CST) at each visit from baseline, secondaryOutcomes measure: Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ophthalmic Consultants of Boston, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Retina Consultants of Texas, status: NOT_YET_RECRUITING, city: Katy, state: Texas, zip: 77494, country: United States, geoPoint lat: 29.78579, lon: -95.8244, locations facility: Wagner Macula & Retina Center, status: NOT_YET_RECRUITING, city: Norfolk, state: Virginia, zip: 23502, country: United States, geoPoint lat: 36.84681, lon: -76.28522, locations facility: The Second Hospital Of Anhui Medical University, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Zhejiang Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Eye Hospital, WMU (Zhejiang Eye Hospital), status: NOT_YET_RECRUITING, city: Wenzhou, state: Zhejiang, country: China, geoPoint lat: 27.99942, lon: 120.66682, locations facility: Beijing Hospital, status: NOT_YET_RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: EYE & ENT Hospital of Fudan University, status: RECRUITING, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, status: NOT_YET_RECRUITING, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False