What side effects are associated with this type of intervention?

Common treatments for Uveitic Macular Edema, such as corticosteroids and anti-inflammatory agents, can have several side effects. Corticosteroids, whether administered systemically or locally, can lead to increased intraocular pressure, cataract formation, and potential infections. Anti-inflammatory agents targeting specific pathways, like Vamikibart, may cause side effects such as ocular discomfort, dry eyes, and potential systemic effects depending on the route of administration. It is essential to monitor patients closely to manage these side effects effectively.

What prior FDA approvals exist?

FDA-approved treatments for Uveitic Macular Edema often include corticosteroids such as triamcinolone acetonide and dexamethasone, which reduce inflammation by inhibiting multiple inflammatory pathways. Additionally, biologic agents like adalimumab, an anti-TNF alpha monoclonal antibody, have been approved for non-infectious uveitis, including uveitic macular edema. These treatments aim to control inflammation and prevent vision loss by targeting specific inflammatory mediators.

What other types of research exist?

Promising novel alternatives to Vamikibart for Uveitic Macular Edema may include other anti-inflammatory agents such as biologics targeting specific inflammatory pathways. Examples include TNF inhibitors (like infliximab or adalimumab), IL-17 inhibitors (like secukinumab or ixekizumab), and IL-23 inhibitors (like guselkumab). These agents have shown efficacy in related inflammatory conditions and may offer potential benefits for Uveitic Macular Edema.

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Vamikibart for Uveitic Macular Edema (Meerkat Trial)

Phase 3

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing vamikibart, a medication that may reduce eye swelling caused by inflammation. It focuses on people with uveitic macular edema, aiming to improve their condition by calming the inflammation in their eyes.

Who is the study for?

This trial is for people with uveitic macular edema, a type of eye swelling. Participants must have certain vision scores and agree to use contraception or abstain from sex if female. They can't join if they've had recent eye treatments, other major eye conditions, systemic infections like syphilis or tuberculosis, HIV, uncontrolled glaucoma, or used specific medications recently.

What is being tested?

The study tests the effectiveness and safety of Vamikibart in treating uveitic macular edema compared to a sham treatment (placebo). It aims to see how well Vamikibart works and monitors any side effects that occur during the trial.

What are the potential side effects?

While not specified here, potential side effects may include typical drug reactions such as irritation at the injection site, changes in vision, increased intraocular pressure, headache or allergic reactions. The exact side effects will be monitored throughout the study.

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm BExperimental Treatment1 Intervention

Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.

Group II: Arm AExperimental Treatment1 Intervention

Participants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.

Group III: Arm CPlacebo Group1 Intervention

Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vamikibart

2021

Completed Phase 2

~400

Do I qualify?Apply below to find out

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 Uveitic Macular Edema primarily involve anti-inflammatory agents that target pathways involved in inflammation. Corticosteroids are frequently used to reduce inflammation and swelling in the retina by inhibiting multiple inflammatory cytokines and mediators. Immunosuppressive agents like methotrexate and cyclosporine are also employed to modulate the immune response and decrease inflammation. Biologic agents, such as anti-TNF (tumor necrosis factor) drugs, target specific inflammatory pathways to reduce retinal swelling. These treatments are crucial for Uveitic Macular Edema patients as they help to control inflammation, prevent further retinal damage, and preserve vision. Vamikibart, being an anti-inflammatory agent, likely works through similar mechanisms to reduce inflammation and improve outcomes for patients.