A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.
Eligibility Criteria
Inclusion Criteria: * Initial diagnosis of nAMD within 24 months prior to screening * Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening * Demonstrated response to prior anti-VEGF IVT treatment since diagnosis * Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD * Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD * BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits Exclusion Criteria: A. Prior Ocular Treatment Study Eye: * History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) * Previous treatment with corticosteroid intravitreal injection * Previous intraocular device implantation * History of