Real-World Efficacy and Safety of the Ranibizumab Port-Delivery System in Neovascular AMD: The SUMMIT Study

Abstract

Purpose : Intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents have transformed the treatment of neovascular age-related macular degeneration (nAMD) but patients require frequent injections and have a high treatment burden. The ranibizumab port-delivery system (PDS) with every 24 weeks refill-exchange is designed to reduce the treatment burden for patients with nAMD and was FDA approved in late 2021. The SUMMIT study is a multi-center retrospective study that is evaluating the efficacy and safety of PDS in the real-world clinical practice.

Methods : Retrospective chart review of patients who received the PDS implant for nAMD, with in-clinic refill-exchange at 24 weeks or more. Efficacy is evaluated through changes in best corrected visual acuity (BCVA), the presence of intraretinal/subretinal fluid (IRF/SRF), change in central subfield thickness (CST) and need for supplementary injections. Safety is reported as occurrence of adverse events.

Results : All eyes post PDS implant (n=25) demonstrated a mean BCVA change of -3.97 letters, attributable to surgical procedure and CST maintenance from baseline to month one. 20 patients completed follow-up visits approximately 15 weeks post-implantation with a mean BCVA change of -1.88 letters and CST reduction of -5.5um from baseline. At 55 weeks, 4 patients completed follow-up visits, demonstrating a mean BCVA increase of +0.78 letters and CST reduction of -20.92um.

Conclusions : Patients with nAMD endure high treatment burden resulting in sub-optimal vision outcomes in the real world clinical practice. PDS is designed to reduce treatment burden while maintaining vision and anatomy in patients with nAMD. The data from the SUMMIT study will evaluate the efficacy and safety of PDS in the real world practice. Latest data will be presented at ARVO 2024.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.