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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Age ≥ 18 years

2. Diagnosis of diabetes mellitus (type 1 or type 2).

3. Macular thickening secondary to DME (CI-DME) involving the center of the fovea on Optical Coherence Tomography - Central subfield thickness (CST) ≥ 325 μm on Spectralis at screening.***

4. Visual impairment due to DME, with best corrected visual acuity of 80 to 20 letters (Snellen VA 20/25 - 20/400).

5. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT and fundus photographs.

6. Hemoglobin A1c must be <10% within 2 months prior to 1st study treatment.

7. Provide signed informed consent.

Exclusion Criteria:

1. Active or history of ocular inflammation or suspected/active ocular infection in either eye.

2. High-risk proliferative diabetic retinopathy in the study eye.**

3. Tractional retinal detachment, preretinal fibrosis or visually significant epiretinal membrane involving the macula.

4. Uncontrolled glaucoma (intraocular pressure >30 with or without medications).

5. Any intravitreal, periocular or implant corticosteroids within 26 weeks (6 months) before day 1 or any use of Iluvien implants.

6. Treatment with Panretinal photocoagulation (PRP) within 12 weeks before day 1.

7. Treatment with macular laser.

8. Any cataract surgery or any other intraocular surgery within 12 weeks before day 1.

9. Macular edema in study eye due to a cause other than DME.

10. If clinical exam and/or OCT and/or wide-field fluorescein angiography (WF-FA) suggest that (a) macular edema is considered to be related to ocular surgery such as cataract extraction or (b) if primary cause for macular edema is vitreoretinal interface abnormalities (e.g. a taut posterior hyaloid or epiretinal membrane).

11. Any ocular condition is present such that visual acuity loss would not improve from resolution of macular edema in opinion of the investigator (e.g. foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition)

12. Any history of ocular conditions that might affect macular edema (e.g. vein occlusion, idiopathic or infectious or non-infectious uveitis, ocular inflammatory disease, neovascular glaucoma etc.)

13. Women of child-bearing potential who are lactating, pregnant, or intending to become pregnant within the next 100 weeks.

14. Current or anticipated incarceration.

15. Terminal illness with expected survival less than 100 weeks.

16. Known hypersensitivity to faricimab or any of the excipients in the faricimab injection.

17. Currently enrolled in a study that does not permit co-enrollment.

18. Unable to obtain informed consent due to language or other operational barriers.

19. Anticipated problems, in the judgment of the site investigator, maintaining compliance with the protocol, including attending study visits, completing assessments or procedures.

20. Prior enrollment in this trial.

21. Other reason to exclude the patient, as approved by the sponsor and site investigator.

22. Previous treatment with anti-VEGF and:

• <12 weeks prior to day 1 (washout period).*or,

• Diagnosis of DME is > 2 years of enrollment or,

• Do not have a demonstrated response to anti-VEGF treatment based on clinical discretion.