What side effects are associated with this type of intervention?

Common treatments for Diabetic Retinopathy, particularly anti-VEGF therapies like Ranibizumab, Aflibercept, and Bevacizumab, are associated with ocular side effects such as increased intraocular pressure, cataracts, vitreous hemorrhage, and retinal detachment. Systemic side effects, though rare, can include hypertension and thromboembolic events. Faricimab, a bispecific antibody targeting Angiopoietin-2 and VEGF-A, may share these side effects and could also present unique risks due to its dual-target mechanism.

What prior FDA approvals exist?

The FDA has approved several treatments for Diabetic Retinopathy that target the VEGF pathway, similar to Faricimab. Aflibercept (Eylea) and Ranibizumab (Lucentis) are anti-VEGF agents that have been approved for the treatment of Diabetic Retinopathy. These drugs work by inhibiting the action of VEGF, thereby reducing abnormal blood vessel growth and leakage in the retina. Bevacizumab (Avastin), another anti-VEGF agent, is also used off-label for this condition. Faricimab, a bispecific antibody targeting both Angiopoietin-2 and VEGF-A, represents a novel approach by addressing two pathways involved in the disease process.

What other types of research exist?

Promising novel alternatives to Faricimab for Diabetic Retinopathy patients include: 1) Aflibercept (VEGF Trap-Eye), which has shown efficacy in reducing diabetic macular edema and improving vision. 2) Ranibizumab (Lucentis), another anti-VEGF therapy with a strong track record in treating diabetic retinopathy. 3) Brolucizumab (Beovu), a newer anti-VEGF agent that offers longer dosing intervals. 4) Conbercept, an emerging anti-VEGF therapy with promising results in clinical trials. 5) Gene therapy approaches targeting VEGF pathways, which are currently under investigation and may offer long-term benefits.

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Monoclonal Antibodies

Faricimab for Diabetic Retinopathy (MAGIC Trial)

Phase 2

Waitlist Available

Research Sponsored by Greater Houston Retina Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ocular inclusion criteria for study eye: Subjects must meet the following ocular inclusion criteria for the study eye for entry into the study: ETDRS BCVA > 20/400 in the study eye, Non-proliferative diabetic retinopathy, as confirmed by the site investigator, Substantial non-perfusion (defined as greater than 5 disc areas on Wide-Field Fluorescein Angiograph (WFFA)), as assessed by site investigator

Diagnosis of diabetes mellitus (type 1 or type 2)

Must not have

Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins or minerals) within 3 months (or 5 half-lives, whichever is longer) prior to Screen/Baseline, or during the course of this study

Ocular exclusion criteria for study eye: Subjects who meet any of the following exclusion criteria for the study eye will be excluded from study entry: Any history of treatment with anti-VEGF or any periocular or IVT corticosteroids in the study eye within 4 months prior to Screen/Baseline, SD-OCT central subfield thickness (CST) measurement > 325 µm, in the study eye due to DME, Evidence of infectious ocular infection, in the study eye at Screen/Baseline, Any pan-retinal photocoagulation (PRP) treatment received in the study eye prior to Screen/Baseline, Retinal vein occlusion in the study eye, Cystoid macular edema not attributed to diabetes (instead caused by epiretinal membrane, macular telangiectasia, Coats disease, and inherited retinal diseases) in the study eye, Current vitreous hemorrhage obscuring imaging in the study and/or dilated indirect examination, Any intraocular surgery (e.g., cataract surgery) within 4 weeks prior to Screen/Baseline in the study eye, Active intraocular inflammation including scleritis at screening/baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks and 96 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of Faricimab are not listed here, similar medications often cause eye irritation or discomfort, increased intraocular pressure, bleeding inside the eye, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with diabetes (type 1 or type 2).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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Your study eye has received certain treatments or surgeries in the past few months, has specific eye conditions, or is currently affected by certain issues, which means you cannot participate in the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks and 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks and 96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks and 96 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Objective

Secondary study objectives

2-step Improvement in DRSS

Change in area of RNP

Change in area of RNP outside of the macula

+6 more

Side effects data

From 2023 Phase 3 trial • 1479 Patients • NCT04432831

13%

COVID-19

11%

Cataract

Diabetic retinal oedema

Nasopharyngitis

Hypertension

Conjunctival haemorrhage

Diabetic retinopathy

Vitreous detachment

Urinary tract infection

Intraocular pressure increased

Vitreous floaters

Posterior capsule opacification

Myocardial infarction

Acute kidney injury

Osteomyelitis

Pneumonia

Localised infection

Skin ulcer

Death

Cardiac failure congestive

Coronary artery disease

Cellulitis

Sepsis

Cerebrovascular accident

Renal failure

COVID-19 pneumonia

Vitreous haemorrhage

100%

80%

60%

40%

20%

Study treatment Arm

Faricimab PTI (Prior Faricimab Q8W)

Faricimab PTI (Prior Aflibercept Q8W)

Faricimab PTI (Prior Faricimab PTI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 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 1Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Faricimab

2023

Completed Phase 3

~7760

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetic Retinopathy, such as Faricimab, work by inhibiting angiogenesis, the process of new blood vessel formation. Faricimab is a bispecific antibody that targets both Angiopoietin-2 and VEGF-A. VEGF-A promotes the growth of abnormal blood vessels that can leak and cause vision loss, while Angiopoietin-2 destabilizes blood vessels, making them more prone to leakage. By inhibiting these pathways, Faricimab helps to reduce vascular leakage and abnormal blood vessel growth, thereby stabilizing or improving vision in patients with Diabetic Retinopathy. This dual-target approach is significant as it addresses multiple mechanisms involved in the disease, potentially offering more comprehensive management of the condition.