drugset / Trial / NCT05126966

A Study Of The Effectiveness And Safety Of A 36-Week Refill Regimen For The Port Delivery System With Ranibizumab Vs Aflibercept Treat & Extend In Subjects With Neovascular Age-Related Macular Degeneration

NCT05126966

Phase 3 Withdrawn Hoffmann-La Roche
RandomizedParallel-groupSingle-blindTreatment

Summary

This study will evaluate the effectiveness and safety of a 36-week refill regimen for the Port Delivery System with ranibizumab 100 mg/mL (PDS Q36W) compared with intravitreal injections of aflibercept (2 mg) administered per treat-and-extend (aflibercept T\&E) in subjects with neovascular (wet) age-related macular degeneration (nAMD).

Timeline

Start
2023-12-29
Primary completion
2025-01-31
Completion
2026-01-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 2 mg Intravitreal
Subject Ranibizumab Monoclonal antibody 2 mg Other