What side effects are associated with this type of intervention?

The most common treatments for Diabetic Macular Edema (DME) include anti-VEGF therapies such as ranibizumab. Known side effects of anti-VEGF treatments include eye pain, increased intraocular pressure, vitreous floaters, and potential risk of endophthalmitis. Combination therapies, like the one being studied with vamikibart and ranibizumab, may have additional side effects, but specific data on vamikibart is not yet available. Patients should discuss potential risks and benefits with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several anti-VEGF therapies for the treatment of Diabetic Macular Edema (DME). Ranibizumab (Lucentis) was one of the first anti-VEGF drugs approved for DME, demonstrating significant efficacy in reducing macular edema and improving vision. Aflibercept (Eylea) is another anti-VEGF agent approved for DME, offering similar benefits. Both drugs work by inhibiting vascular endothelial growth factor (VEGF), which plays a key role in the pathogenesis of DME. These treatments are similar to the ones being studied in the Vamikibart trial, which aims to enhance the effects of anti-VEGF therapy.

What other types of research exist?

Promising novel alternatives to Vamikibart for enhancing the effects of anti-VEGF therapy in Diabetic Macular Edema patients include Faricimab, a bispecific antibody targeting both VEGF and Angiopoietin-2, and KSI-301, an anti-VEGF antibody biopolymer conjugate designed for extended durability. Both have shown positive results in clinical trials and are expected to be significant options in 2024.

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Anti-VEGF inhibitor

Vamikibart + Ranibizumab for Diabetic Macular Edema

Phase 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Diagnosis of diabetes mellitus (Type 1 or Type 2)

Decreased visual acuity attributable primarily to DME

Must not have

Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye

Prior treatment with panretinal photocoagulation or macular laser to the study eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, vamikibart, combined with an existing treatment, ranibizumab, in people with diabetic macular edema. The goal is to better control fluid buildup in the eye and improve vision.

Who is the study for?

This trial is for individuals with Type 1 or Type 2 diabetes who have decreased vision due to diabetic macular edema (DME) affecting the center of their retina. Women must use effective contraception and not be pregnant. Participants should not have other eye diseases, uncontrolled blood pressure, certain prior treatments like laser therapy or specific drugs, and no recent corticosteroid treatment in the study eye.

What is being tested?

The study compares a new treatment combining Vamikibart with Ranibizumab against using only Ranibizumab for DME. It's randomized and double-masked, meaning neither participants nor researchers know who gets which treatment. The trial will last about 76 weeks and includes tests on how safe it is and how it affects the body.

What are the potential side effects?

Potential side effects may include reactions at the injection site in the eye, increased risk of eye infection or inflammation, possible changes in intraocular pressure, as well as general side effects such as headache or nausea related to systemic absorption.

Eligibility Criteria

Inclusion Criteria

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

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

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My vision loss is mainly due to diabetic macular edema.

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I have swelling in the center of my retina due to diabetes.

Exclusion Criteria

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

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I have no eye conditions affecting my central vision other than DME.

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I have had laser treatment on my eye.

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I have an active eye infection or inflammation in my study eye.

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I have a type of eye damage from diabetes that affects my vision.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Active Control

Group I: Arm A: Vamikibart + RanibizumabExperimental Treatment2 Interventions

Participants will receive vamikibart, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.

Group II: Arm B: RanibizumabActive Control2 Interventions

Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vamikibart

2021

Completed Phase 2

~400

Ranibizumab

2017

Completed Phase 4

~2080

0 / 7Eligibility 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

The most common treatments for Diabetic Macular Edema (DME) involve anti-VEGF therapies, such as ranibizumab, which inhibit the vascular endothelial growth factor (VEGF). VEGF promotes the growth of abnormal blood vessels in the retina, leading to fluid leakage and swelling in the macula. By blocking VEGF, these treatments reduce macular edema and improve vision. Vamikibart, currently being studied in combination with ranibizumab, may enhance the effects of anti-VEGF therapy, offering potentially greater reductions in macular edema and better visual outcomes. This is vital for DME patients as it directly targets the cause of vision impairment, aiming to preserve and improve their quality of life.