Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2026-06-01

Summary

This study is evaluating diabetic macular edema (DME), a complication of diabetes, where fluid accumulation can cause swelling in the eye(s). Specifically, DME is the buildup of fluid in the retina (a layer of tissue at the back of the eye). This is a common but serious complication of diabetes and is one of the leading causes of vision loss in the developed world. To treat the fluid buildup, doctors often use a type of medication called anti-vascular endothelial growth factor (Anti-VEGF) that is injected into the affected eye on a set schedule. One specific Anti-VEGF medication is called Faricimab and it is usually injected every 4 weeks. In this study, we are looking to determine if DME can be effectively managed with less frequent injections, meaning fewer visits and a lower time commitment for patients and hospital staff. Less frequent injections may also reduce the costs of DME treatment. Instead of using a fixed schedule for injections, this study will test a new approach that will allow the doctor to adjust how often the injections are given, based on how well the eye is responding to treatment. This is called the Treat & Extend (T&E) Approach.

• Phase: Phase 3

Details

• Lead Sponsor: McMaster University
• Collaborator: Hoffmann-La Roche