Vamikibart for Uveitic Macular Edema

(Meerkat Trial)

No longer recruiting at 154 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests vamikibart, a new treatment for uveitic macular edema, a condition where inflammation causes swelling at the back of the eye. The study aims to determine the safety and effectiveness of this treatment. Participants will be divided into three groups: one receiving a high dose, another a low dose, and a third receiving a sham (placebo) treatment. Individuals with macular edema from non-infectious uveitis who meet specific vision criteria may be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that vamikibart has been tested in people with uveitic macular edema, primarily to assess its safety. In one study, some participants experienced side effects such as eye problems and inflammation. However, the overall results indicated that vamikibart is generally safe for most people, as most did not encounter serious issues. While these findings are encouraging, individual experiences can vary. It is important to consult a healthcare provider about any concerns before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for uveitic macular edema, like corticosteroids or anti-VEGF injections, focus on reducing inflammation or inhibiting blood vessel growth. But vamikibart works differently, targeting the underlying cellular pathways involved in the disease with its unique mechanism of action. Researchers are excited because vamikibart, delivered via intravitreal injections, offers the potential for a more direct and potentially more effective approach by directly modulating these pathways. The treatment's ability to tailor dosing as needed after initial administrations could also mean more personalized and flexible care for patients.

What evidence suggests that this trial's treatments could be effective for uveitic macular edema?

Research has shown that vamikibart is a promising new treatment for uveitic macular edema (UME), a condition that causes swelling in the eye due to inflammation. This trial will evaluate different dosages of vamikibart, with participants receiving either high-dose or low-dose injections. Studies have found that vamikibart targets the inflammation causing UME, making it the first non-steroid option available. In earlier trials, patients experienced improvements in vision and eye health with few eye-related side effects. These results suggest that vamikibart could be an effective and safer alternative to current UME treatments. ^{1 3 4 5 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. roche.com roche.com/media/releases/med-cor-2025-10-17b

Roche presents new phase III pivotal data for vamikibart in ... Vamikibart is the first non-steroid targeted therapy designed to address inflammation driving UME and may offer a potential new treatment ...

2. gene.com gene.com/media/press-releases/15082/2025-10-17/genentech-presents-new-phase-iii-pivotal

Genentech: Press Releases | Friday, Oct 17, 2025 Vamikibart is the first non-steroid targeted therapy designed to address inflammation driving UME and may offer a potential new treatment ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05642325

Vamikibart in Participants With Uveitic Macular Edema ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/eye-disorder/uveitic-macular-edema/ro7200220-in-participants-with-uveitic-macular-edema-91001.html

Clinical trial for Uveitic Macular Edema-Genentech A Memb... Study Summary. This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema. Eligibility Criteria. Gender. All.

5. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/genentech-meerkat-sandcat-trials-vision-anatomical-gains-vamikibart-uveitic-macular-edema

Genentech's Phase III MEERKAT and SANDCAT Trials ... Vamikibart showed a favorable safety profile with low ocular adverse event rates. Results support its potential as the first non-steroid ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06771271

NCT06771271 | A Study to Investigate RO7200220 as ... The purpose of this study was to assess the safety and tolerability of RO7200220 as monotherapy (diabetic macular edema [DME] or uveitic macular edema [UME] ...