This study evaluates SKG0106, a treatment injected into the eye, in patients with neovascular age-related macular degeneration (a condition affecting the retina). It enrolls patients aged 50 and older who have previously responded to anti-VEGF therapy and have not had prior gene therapy. The study is in Phase 1/Phase 2 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion criteria: 1. 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; 2. Aged ≥ 50 years at screening; Study Eye: 3. Diagnosis of nAMD as determined by the PI; 4. Active CNV lesions secondary to age-related macular degeneration (AMD); 5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment. Exclusion Criteria: 1. 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; 2. Retinal pigment epithelial tear in the study eye at screening; 3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline; 4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye; 5. History of retinal detachment or active retinal detachment in the study eye; 6. Any prior gene therapy.