Vamikibart for Uveitic Macular Edema
(Meerkat Trial)

Recruiting in Palo Alto (17 mi)

+124 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts

I agree to follow the study's rules on abstinence or contraception.

I have swelling in the eye due to non-infectious uveitis.

+1 more

Exclusion Criteria

I haven't had certain eye injections in the last 2-4 months.

I have had major eye or other surgeries.

Evidence of active or latent syphilis infection

+8 more

Participant Groups

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.

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.