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

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

Outcome

Met primary endpoint

registry PDS With Ranibizumab 100 mg/mL vs Comparator Arm; p <0.0001; CMH Weighted Percentage Difference 71.1 (95.04% CI 61.0 to 81.2) NCT04503551 ↗

paper 80.1% of those receiving PDS Q36W vs 9.0% of control participants had at least a 2-step DRSS improvement PMID 40048178 ↗

release “People with DR who received Susvimo refilled every nine months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS).” roche.com ↗

Publications

• Pieramici DJ, Awh CC, Chang M, Emanuelli A, Holekamp NM, Hu AY, Suner IJ, Wykoff CC, Brittain C, Howard D, Quezada-Ruiz C, Santhanakrishnan A, Latkany P. Port Delivery System With Ranibizumab vs Monitoring in Nonproliferative Diabetic Retinopathy Without Macular Edema: The Pavilion Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 1;143(4):317-325. doi: 10.1001/jamaophthalmol.2025.0001.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranibizumab	Monoclonal antibody	0.5 mg	Other
Subject	Ranibizumab	Monoclonal antibody	100 mg/ml	Other

Indications