RO7200220 for Diabetic Macular Edema

No longer recruiting at 65 trial locations

Overseen By Reference Study ID Number: BP43445 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Uncontrolled hypertension, Pregnancy, others

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

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

Compensation: Varies

Number of Visits: 12

Duration: 44 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called vamikibart (also known as RO7200220) for diabetic macular edema (DME), which causes vision problems due to fluid buildup in the eye's macula. The study compares different doses and schedules of vamikibart against an existing treatment, ranibizumab, to evaluate their effectiveness and safety. People with diabetes who have vision issues primarily due to DME might be suitable candidates for this trial. Participants will receive injections in the eye and must be willing to follow the study guidelines. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments related to eye conditions, like anti-VEGF therapy, must be stopped for a specific period before starting the trial.

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

Research has shown that vamikibart has been tested for safety in people with diabetic macular edema and other eye conditions. Administered as an injection directly into the eye, previous studies have examined its tolerability and monitored side effects. Some reported side effects include eye inflammation and other eye-related issues, but these are generally manageable.

Vamikibart has also received approval for treating certain eye conditions in various countries, indicating confidence in its safety when used correctly. However, since everyone reacts differently to treatments, discussing any concerns with a healthcare provider is advisable before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about vamikibart for diabetic macular edema because it introduces a potentially new way to manage the condition. Unlike the standard treatment, ranibizumab, which requires frequent injections every four weeks, vamikibart offers flexible dosing schedules, including every eight weeks, potentially reducing the treatment burden on patients. Additionally, vamikibart might work through a distinct mechanism of action, though specifics aren't detailed here, which could offer a new approach for those who don't respond well to current therapies. These features might improve patient compliance and outcomes, making vamikibart a promising candidate in the field.

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

Research has shown that vamikibart, a treatment under study in this trial, may improve vision and reduce eye swelling in patients. In earlier studies, vamikibart quickly enhanced vision, offering hope for those with diabetic macular edema. Patients experienced significant improvements from their initial vision, suggesting the treatment's potential effectiveness. These early results support further research into vamikibart as a treatment option for this condition. ^{1 2 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 adults with diabetic macular edema, a condition causing swelling in the eye. Participants must have diabetes (Type 1 or Type 2), decreased vision due to DME, and agree to use effective contraception if applicable. They can't join if they've had certain treatments like anti-VEGF therapy recently, uncontrolled blood pressure, HbA1c >12%, are pregnant/breastfeeding, or have other eye conditions that affect vision.

Inclusion Criteria

Willingness to allow Aqueous Humor collection

Ability and willingness to provide written informed consent and to comply with the study protocol

For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of <1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment

Exclusion Criteria

I have never received Beovu® or received RO7200220 within the last 24 weeks.

Other protocol-specified inclusion/exclusion criteria may apply

Hemoglobin A1c (HbA1c) of greater than (>) 12%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravitreal injections of either vamikibart or ranibizumab, with varying dosages and frequencies, up to Week 44

44 weeks

12 visits (in-person) for Q4W arms, 6 visits (in-person) for Q8W arms

Follow-up

Participants are monitored for safety and effectiveness after treatment

32 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ranibizumab
• RO7200220

Trial Overview The study tests Vamikibart's effectiveness against diabetic macular edema compared to Ranibizumab and a sham procedure. It's double-masked meaning neither participants nor researchers know who gets which treatment. The trial lasts up to 76 weeks and includes safety assessments and checks on how the body processes the drug.

How Is the Trial Designed?

Group I: Arm C: 1.0 mg Vamikibart Q4W Experimental Treatment 1 Intervention

Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections.

Group II: Arm B: 1.0 mg Vamikibart Q8W Experimental Treatment 2 Interventions

Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.

Group III: Arm A: 0.25 mg Vamikibart Q8W Experimental Treatment 2 Interventions

Participants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms.

Group IV: Arm D: 0.5 mg Ranibizumab Q4W Active Control 1 Intervention

Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections.

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

Published Research Related to This Trial

In a study of 50 patients with diabetic macular edema, both ranibizumab (RZB) and dexamethasone implant (DEX) treatments significantly improved visual acuity and central macular thickness over 6 months, with DEX showing a greater improvement in visual acuity.

The DEX group had a lower retreatment rate compared to the RZB group, although two patients in the DEX group experienced increased intraocular pressure, indicating a potential safety concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical and functional changes after dexamethasone implant and ranibizumab in diabetic macular edema: a retrospective cohort study. Mastropasqua, L., Di Staso, S., D'Aloisio, R., et al.[2020]

In a study of 40 patients with retinal vein occlusion treated with ranibizumab, 100% of patients with central retinal vein occlusion (CRVO) experienced recurrence of macular edema (ME), compared to 59% in those with branch retinal vein occlusion (BRVO).

Recurrences of ME occurred sooner and lasted longer in the CRVO group, with a mean interval of 1.2 months between injections, compared to 2.4 months for the BRVO group, highlighting the need for closer monitoring and potentially more aggressive treatment in CRVO patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence of macular edema in retinal vein occlusions after treatment with intravitreal ranibizumab (Lucentis). Karagiannis, DA., Karampelas, MD., Soumplis, VM., et al.[2016]

In a study of 12 patients with macular edema due to branch retinal vein occlusion, intravitreal bevacizumab (IVB) injections significantly improved visual acuity and reduced central macular thickness over a mean follow-up of 9.8 months.

No ocular or systemic side effects were reported, indicating that IVB is a safe and effective treatment option for managing macular edema associated with BRVO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal bevacizumab for macular oedema secondary to branch retinal vein occlusion. Gündüz, K., Bakri, SJ.[2015]

In a study involving five patients with refractory macular edema due to branch retinal vein occlusion, treatment with intravitreal Pegaptanib sodium resulted in significant improvements in both visual acuity and macular edema after three months.

The findings suggest that Pegaptanib sodium is a safe and effective option for patients who do not respond to other treatments like bevacizumab or triamcinolone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal pegaptanib for refractory macular edema secondary to retinal vein occlusion. Udaondo, P., Garcia-Delpech, S., Salom, D., et al.[2021]

Citations

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

Roche presents new phase III pivotal data for vamikibart in ... Consistently across both trials, key secondary endpoints showed rapid and clinically meaningful improvements in average change from baseline in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05151744

NCT05151744 | A Study to Investigate Vamikibart ... A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema. ClinicalTrials.gov ID NCT05151744. Sponsor Hoffmann ...

3. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/eye-disorder/dme/a-study-to-investigate-ro7200220-in-diabetic-macular-ed-90636.html

A Study to Investigate RO7200220 in Diabetic Macular Edema Access the clinical trial testing the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7200220 administered intravitreally in ...

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

Genentech: Press Releases | Friday, Oct 17, 2025 In the Phase I DOVETAIL study, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME. Vamikibart was ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05151731

A Study to Investigate Vamikibart (RO7200220) in Diabetic ... A phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and ...

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] ...