drugset / Trial / NCT05562947

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)

NCT05562947

Phase 3 Recruiting 68 enrolled Hoffmann-La Roche
RandomizedParallel-groupSingle-blindTreatment

Summary

This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.

Timeline

Start
2024-06-17
Primary completion
2027-07-27
Completion
2029-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.5 mg Intravitreal
Subject Ranibizumab Monoclonal antibody 2 mg Intravitreal