Phase III Study of 36-Week Refill Treatment Using the Port Delivery System with Ranibizumab for Neovascular Age-related Macular Degeneration

What this Trial Is About

Researchers are evaluating a port delivery system PDS with ranibizumab for adults aged 50 and older who have neovascular age-related macular degeneration nAMD. This Phase IIIb study aims to assess the effectiveness, safety, and patient-reported outcomes of refilling the PDS implant every 36 weeks. The study focuses on maintaining vision and reducing the treatment burden for people with nAMD who have already received prior anti-VEGF injections. Participants will have a PDS implant surgically inserted in their study eye on Day 1, pre-filled with ranibizumab at a concentration of 100 mgmL. Those who show disease activity or receive supplemental ranibizumab injections before Week 24 will have refill exchanges every 24 weeks, while others will receive refill exchanges every 36 weeks. Supplemental intravitreal ranibizumab injections may be given as needed during the study. Throughout the trial, participants will undergo assessments including vision tests using the Early Treatment Diabetic Retinopathy Study chart, eye imaging, and monitoring of eye thickness. Researchers will track changes in vision, need for supplemental treatments, implant safety, and patient preferences. The study lasts until Week 72, with safety and adverse event monitoring continuing for approximately 19 months after implantation.

A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD