Vamikibart for Uveitic Macular Edema

(Meerkat Trial)

Recruiting at 124 trial locations

Overseen By Reference Study ID Number: GR44277 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must not be taking: IVT biologics, Methotrexate

Disqualifiers: Syphilis, Tuberculosis, HIV, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

245 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot have used certain eye treatments like IVT biologics, methotrexate, or specific implants within a few months before starting. It's best to discuss your current medications with the trial team.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 injections of vamikibart or sham every 4 weeks until Week 12

12 weeks

4 visits (in-person)

PRN Dosing

Participants receive as-needed dosing from Week 20 to Week 48

28 weeks

PRN visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RO7200220

Trial Overview 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.

Participant Groups

Group I: Arm B Experimental Treatment 1 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 A Experimental Treatment 1 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 C Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University