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

A Phase III, Multicenter, Randomized Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Retinopathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	PDS Implant Pre-Filled with 100 mg/mL Ranibizumab	Will be administered as per the schedule described in individual arm.
DRUG	Intravitreal Ranibizumab 0.5 mg Injection	Will be administered as per the schedule described in individual arm.

Timeline

• Start date: 2020-08-10
• Primary completion: 2022-10-03
• Completion: 2026-02-23
• First posted: 2020-08-07
• Last updated: 2026-04-02
• Results posted: 2025-11-25

Locations

65 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study