drugset / Trial / NCT04657289

A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

NCT04657289

Phase 3 Active not recruiting 451 enrolled Hoffmann-La Roche
RandomizedParallel-groupSingle-blindTreatment

Summary

Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

Timeline

Start
2021-07-14
Primary completion
2027-01-28
Completion
2027-01-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 100 mg/ml Other