Faricimab for Diabetic Retinopathy

(MAGIC Trial)

Not currently recruiting at 16 trial locations

Overseen By Charles Wykoff, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Greater Houston Retina Research

Must not be taking: Systemic anti-VEGF

Disqualifiers: Active cancer, Stroke, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 96 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests faricimab, a new treatment for non-proliferative diabetic retinopathy, a condition where diabetes causes vision problems. Researchers aim to determine faricimab's safety, effectiveness, and patient tolerance. Participants will be divided into two groups to receive different treatment schedules. Individuals may qualify if they have diabetes, non-proliferative diabetic retinopathy, and significant vision issues due to the condition. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you've had systemic anti-VEGF treatment within 4 months before the trial or if you've been in another drug trial within 3 months before the trial.

Is there any evidence suggesting that faricimab is likely to be safe for humans?

Research has shown that faricimab has been studied for its safety in treating eye conditions. Most patients tolerate it well. Common side effects include cataracts, a clouding of the eye lens, in about 10% of patients, and bleeding in the outer layer of the eye in about 7% of patients. These side effects are usually manageable. The FDA has already approved faricimab for other eye issues, indicating that its safety is well-documented. While this trial aims to understand its effects on diabetic retinopathy, existing data provides some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Faricimab is unique because it introduces a novel mechanism of action for treating diabetic retinopathy. Unlike other treatments, such as anti-VEGF therapies like ranibizumab or aflibercept, which primarily target one pathway, faricimab is a bispecific antibody that targets both VEGF-A and Ang-2 pathways. This dual-targeting approach has the potential to reduce inflammation and improve vascular stability more effectively. Researchers are excited about faricimab because it may offer improved outcomes and potentially longer intervals between treatments, enhancing convenience and adherence for patients.

What evidence suggests that faricimab could be an effective treatment for diabetic retinopathy?

Research shows that faricimab holds promise for treating diabetes-related eye problems. Studies have found that it can improve vision and reduce eye swelling. Notably, faricimab helps reverse damage to the retina's blood vessels, known as diabetic retinopathy. The treatment targets two causes of eye damage, potentially offering better long-term control. In this trial, participants in Group 1 will receive faricimab every 4 weeks initially, then every 16 weeks starting at Week 48. Participants in Group 2 will be observed every 16 weeks and will receive faricimab every 4 weeks starting at Week 48. Previous patients maintained vision improvements with treatment every 12 or 16 weeks, suggesting faricimab could effectively manage diabetes-related eye issues. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in Group 1 receive intravitreal faricimab every 4 weeks through week 48, then every 16 weeks until week 96. Group 2 is observed every 16 weeks until week 48, then receives faricimab every 4 weeks until week 92.

96 weeks

Every 4 weeks or every 16 weeks depending on group

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Faricimab

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Vabysmo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)
• Macular edema following retinal vein occlusion (RVO)

Approved in European Union as Vabysmo for:

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

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

Published Research Related to This Trial

The phase III BALATON/COMINO trials will assess the efficacy and safety of faricimab in treating diabetic macular edema due to retinal vein occlusion, involving 1282 patients across 22 countries.

Faricimab is being compared to aflibercept using a personalized treatment approach that adjusts dosing intervals based on individual patient responses, aiming to demonstrate noninferiority in visual acuity outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. Hattenbach, LO., Abreu, F., Arrisi, P., et al.[2023]

Faricimab, a bispecific antibody, showed non-inferior efficacy compared to aflibercept in improving best-corrected visual acuity in patients with neovascular age-related macular degeneration (nAMD) over two phase 3 trials involving 1329 patients.

The trials demonstrated that faricimab can be administered up to every 16 weeks, potentially reducing the treatment burden for patients while maintaining similar safety profiles to aflibercept, with comparable rates of ocular adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Heier, JS., Khanani, AM., Quezada Ruiz, C., et al.[2023]

Faricimab, a dual-target antibody for VEGF-A and Ang-2, has shown comparable efficacy to monthly ranibizumab in treating neovascular age-related macular degeneration, allowing for longer intervals between injections and fewer treatments overall.

In the BOULEVARD trial, faricimab significantly improved diabetic retinopathy severity in 38.6% of patients treated with the highest dose, outperforming ranibizumab, indicating its potential for effective long-term management of diabetic macular edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Faricimab: from research to clinical practice]. Yusef, YN., Budzinskaya, MV., Plyukhova, AA.[2023]

In a study of 51 patients with treatment-resistant diabetic macular edema (DME), switching from intravitreal aflibercept (IVA) to intravitreal faricimab (IVF) resulted in significant improvements, with 39.2% achieving a treatment interval of 8 weeks or more and a fluid-free macula after 12 months.

The central macular thickness (CMT) decreased significantly from 400.2 microns to 340.6 microns, and 21.6% of patients experienced a visual acuity improvement of 3 lines or more, indicating that IVF may be an effective alternative for patients not responding to IVA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One Year Results of Faricimab for Aflibercept-Resistant Diabetic Macular Edema. Rush, RB.[2023]

In a study of 26 patients with neovascular age-related macular degeneration (nAMD), switching to intravitreal faricimab resulted in a significantly longer fluid-free interval compared to previous treatments with anti-VEGF agents, indicating improved efficacy.

No serious adverse events were reported, suggesting that faricimab is a safe option for patients who did not respond well to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal faricimab for neovascular age-related macular degeneration previously treated with traditional anti-VEGF compounds: a real-world prospective study. Grimaldi, G., Cancian, G., Rizzato, A., et al.[2023]

Faricimab demonstrated significant improvements in best-corrected visual acuity (BCVA) for patients with diabetic macular edema, with similar efficacy observed in both Asian (average gain of +10.4 letters) and non-Asian (average gain of +11.1 letters) subgroups after one year.

The treatment was well tolerated with no new safety concerns, and a high percentage of patients in both groups achieved extended dosing intervals, indicating the durability of the treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Durability, and Safety of Faricimab in Patients From Asian Countries With Diabetic Macular Edema: 1-Year Subgroup Analysis of the Phase III YOSEMITE and RHINE Trials. Ishida, S., Chen, SJ., Murata, T., et al.[2023]

Faricimab is a bispecific antibody that targets both VEGF-A and Ang-2, and it has been approved in the USA for treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The drug is administered via intravitreal injection and is currently undergoing Phase III clinical trials for additional retinal vascular diseases, indicating its potential for broader therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Faricimab: First Approval. Shirley, M.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04740905

NCT04740905 | A Study to Evaluate the Efficacy and ... Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm. Other Names: VABYSMO®; faricimab-svoa; RO6867461; RG7716.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK601678/

Clinical Review - Faricimab (Vabysmo) - NCBI - NIH The clinician group noted that clinically meaningful outcomes include improvement in vision, reduction or resolution of macular edema, regression in Diabetic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03622580

NCT03622580 | A Study to Evaluate the Efficacy and ... This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7393587/

The AVENUE Phase 2 Randomized Clinical Trial - PMC STAIRWAY demonstrated that faricimab at 16- and 12-week dosing intervals resulted in maintenance of vision and anatomical improvements ...

5. assets.roche.com assets.roche.com/f/203780/x/8de4ac9bce/vabysmo-product-information-ro-6867461-november-2023.pdf

VABYSMO® INN: Faricimab An additional key efficacy outcome in DME studies was the change in the Early Treatment. Diabetic Retinopathy Study Diabetic Retinopathy ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03622593

NCT03622593 | A Study to Evaluate the Efficacy and ... This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2022/761235Orig1s000MedR.pdf

761235Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov Safety of Faricimab (RO6867461) in Patients with Diabetic Macular Edema. 6.3.1. Study Design. Primary Objective: Evaluate the efficacy of ...

8. ema.europa.eu ema.europa.eu/en/documents/assessment-report/vabysmo-epar-public-assessment-report_en.pdf

Assessment report - Vabysmo - EMA - European Union efficacy and safety of faricimab (RO6867461) in patients with diabetic macular edema (YOSEMITE). Study identifier. GR40349, YOSEMITE.