Faricimab for Diabetic Retinopathy

(MAGIC Trial)

Recruiting at16 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Greater Houston Retina Research

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing faricimab, a medication injected into the eye, in patients with Non-Proliferative Diabetic Retinopathy. The goal is to see if it is safe and effective in stopping or slowing down eye damage caused by diabetes. Faricimab works by blocking proteins that cause harmful changes in the eye's blood vessels.

Research Team

Eligibility Criteria

Adults over 18 with diabetes (type 1 or type 2) and non-proliferative diabetic retinopathy, who can follow the study schedule. Women must use effective contraception or abstain from sex. Exclusions include recent stroke or heart attack, certain eye treatments, active cancer within a year, pregnancy, and known allergies to study-related substances.

Inclusion Criteria

My study eye has vision better than 20/400, non-proliferative diabetic retinopathy, and significant non-perfusion.

I agree to use highly effective birth control or remain abstinent during and 3 months after treatment.

I am over 18 and can sign the consent form.

Exclusion Criteria

I have not had a stroke or heart attack in the last 6 months.

I have not been in a drug or device trial within the last 3 months or 5 half-lives.

I haven't taken any anti-VEGF treatments in the last 4 months.

Treatment Details

Interventions

• Faricimab (Monoclonal Antibodies)

Trial Overview The trial is testing Faricimab's safety and effectiveness in treating Non-Proliferative Diabetic Retinopathy (NPDR). Participants are divided into two groups; details on how they're split aren't provided here.

Participant Groups

Group I: Group 2 Experimental Treatment 1 Intervention

Subjects are seen and observed every 16 weeks. Starting at Week 48, subjects will be administered intravitreal faricimab 6 mg every 4 weeks from week 48 to week 92, (defined as every 28 days ± 7 days and at least 21 days between injections) with an end of study visit at week 96. Rescue: At any visit before Week 48, if rescue criteria are met, faricimab 6mg will be given every 4 weeks and the subject will continue dosing through the end of the trial.

Group II: Group 1 Experimental Treatment 1 Intervention

Subjects will be administered intravitreal faricimab 6 mg every 4 weeks (defined as every 28 days + 7 days and at least 21 days between injections) through week 48. Starting at Week 48, subjects will be treated every 16 weeks (weeks 48, 64 \& 80) with an end of study visit at week 96. Rescue: At any visit after Week 48, if rescue criteria are met, faricimab 6mg will be given every 4 weeks and the subject will continue dosing through the end of the trial.

Faricimab is already approved in Canada for the following indications:

Approved in Canada as Vabysmo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)

Who Is Running the Clinical Trial?

Greater Houston Retina Research

Lead Sponsor

Trials

10

Recruited

10,500+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD