drugset / Trial / NCT04503551

A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm

NCT04503551

Phase 3 Completed 174 enrolled Hoffmann-La Roche
RandomizedParallel-groupSingle-blindTreatment

Summary

Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm

Timeline

Start
2020-08-10
Primary completion
2022-10-03
Completion
2026-02-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Ranibizumab Monoclonal antibody 0.5 mg Other
Subject Ranibizumab Monoclonal antibody 100 mg/ml Other

Indications