Comparing the Port Delivery System With Ranibizumab Implant to Monthly Ranibizumab Injections for Chinese Patients With Neovascular Age-related Macular Degeneration

What this Trial Is About

Researchers are evaluating the efficacy, safety, and pharmacokinetics of ranibizumab delivered via a Port Delivery System PDS implant compared to monthly intravitreal injections of ranibizumab in Chinese participants with neovascular age-related macular degeneration nAMD. This Phase 3 study includes participants aged 50 years and older who have had a recent diagnosis of nAMD and prior treatment with anti-VEGF injections, aiming to assess visual acuity changes and treatment outcomes. Participants are randomly assigned to either receive a surgical insertion of the PDS implant filled with ranibizumab 100 mgmL, with scheduled refill-exchanges every 24 weeks, or to receive monthly intravitreal injections of ranibizumab 0.5 mg up to Week 44. At Week 48, those in the injection group will also receive the PDS implant and continue with refill-exchanges every 24 weeks. Participants will attend monthly visits up to Week 96 and then visits every two months until the study ends, which may extend to over four years. During the trial, participants undergo regular assessments including measurements of best-corrected visual acuity using the ETDRS chart, imaging of the eye through various methods, and monitoring of ranibizumab blood levels and immune response. Safety is closely tracked through adverse event reporting. The primary outcome is the change from baseline in visual acuity averaged between Weeks 36 and 40, with additional evaluations continuing up to Week 144. Participants remain under study observation until the study completion date in 2029.

A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)