Vamikibart + Ranibizumab for Diabetic Macular Edema

No longer recruiting at 68 trial locations

Overseen By Reference Study ID Number:BP43464 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must be taking: Anti-VEGF

Must not be taking: Corticosteroids, Beovu

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

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 combination for diabetic macular edema, a condition that causes retinal swelling and affects vision due to diabetes. The study compares the effectiveness and safety of combining two drugs, vamikibart (RO7200220) and ranibizumab, against using ranibizumab alone. Participants will receive regular eye injections and be monitored over 76 weeks. Individuals with diabetes who experience vision problems primarily due to this condition might be suitable for the trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, certain treatments related to eye conditions, like anti-VEGF therapy, must not have been used recently. It's best to discuss your specific 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, when combined with ranibizumab (a drug that helps prevent the growth of blood vessels), is generally well-tolerated by people with diabetic macular edema. In earlier studies, patients taking vamikibart did not report any unexpected side effects. The FDA has already approved ranibizumab for certain eye conditions, and it is widely used and considered safe for treating diabetic macular edema.

While both drugs have demonstrated safety, side effects can vary from person to person. Participants in a trial will be closely monitored to ensure their well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for diabetic macular edema because Vamikibart, in combination with Ranibizumab, offers a novel approach. Unlike the standard of care, which typically involves anti-VEGF treatments like Ranibizumab alone, Vamikibart introduces a new mechanism by potentially targeting additional pathways involved in the disease. This dual approach could enhance effectiveness and provide better outcomes for patients by addressing multiple aspects of the condition simultaneously. Furthermore, the combination therapy is designed to be administered via intravitreal injections every four weeks, which aligns with current practices, making it easier to integrate into existing treatment regimens.

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

Research has shown that ranibizumab can improve vision for people with diabetic macular edema (DME). It blocks a protein that causes abnormal blood vessel growth in the eye, which can lead to vision issues. In this trial, some participants will receive ranibizumab alone, while others will receive a combination of vamikibart and ranibizumab. Studies suggest that combining vamikibart with ranibizumab might enhance these benefits. Early results indicate that this combination quickly and significantly improves vision clarity and reduces eye swelling. These promising findings support the potential effectiveness of using vamikibart and ranibizumab together to treat DME. ^{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 individuals with Type 1 or Type 2 diabetes who have decreased vision due to diabetic macular edema (DME) affecting the center of their retina. Women must use effective contraception and not be pregnant. Participants should not have other eye diseases, uncontrolled blood pressure, certain prior treatments like laser therapy or specific drugs, and no recent corticosteroid treatment in the study eye.

Inclusion Criteria

Willingness to allow Aqueous Humor collection

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

I have been diagnosed with diabetes (Type 1 or Type 2).

Exclusion Criteria

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

I have an eye condition not related to DME that could cause permanent vision loss.

I have no eye conditions affecting my central vision other than DME.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vamikibart in combination with ranibizumab or ranibizumab alone, administered as intravitreal injections every fourth week up to Week 44

44 weeks

12 visits (in-person)

Observational

Participants are observed without active treatment to monitor outcomes up to Week 72

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ranibizumab
• RO7200220
• Sham Procedure

Trial Overview The study compares a new treatment combining Vamikibart with Ranibizumab against using only Ranibizumab for DME. It's randomized and double-masked, meaning neither participants nor researchers know who gets which treatment. The trial will last about 76 weeks and includes tests on how safe it is and how it affects the body.

How Is the Trial Designed?

Group I: Arm A: Vamikibart + Ranibizumab Experimental Treatment 2 Interventions

Participants will receive vamikibart, 1 milligram (mg) administered as intravitreal (IVT) injection in combination with ranibizumab, 0.5 mg IVT, on Day 1 and every fourth week (Q4W) up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.

Group II: Arm B: Ranibizumab Active Control 2 Interventions

Participants will receive ranibizumab, 0.5 mg IVT, from Day 1 and Q4W in combination with sham up to Week 44, for a total of 12 injections, followed by an observational period up to Week 72.

Ranibizumab is already approved in European Union, United States for the following indications:

Approved in European Union as Lucentis for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)
• Macular edema following retinal vein occlusion (RVO)
• Diabetic retinopathy (DR)
• Myopic choroidal neovascularization (mCNV)

Approved in United States as Lucentis/Susvimo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)
• Macular edema following retinal vein occlusion (RVO)
• Diabetic retinopathy (DR)
• Myopic choroidal neovascularization (mCNV)

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

Intravitreal injections of ranibizumab significantly improved visual acuity and reduced central retinal thickness in patients with macular edema due to retinal vein occlusion, with average improvements of 9 letters in visual acuity and a decrease of 195 μm in retinal thickness after each injection.

The treatment was found to be safe, with no local or systemic adverse effects reported, but further long-term studies are needed to compare its efficacy against the natural progression of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal ranibizumab for macular oedema secondary to retinal vein occlusion: a retrospective study of 34 eyes. Puche, N., Glacet, A., Mimoun, G., et al.[2015]

Ranibizumab treatment significantly improved diabetic retinopathy (DR) outcomes, especially in patients with moderately severe to severe nonproliferative DR, showing a 78.4% to 81.1% rate of 2-step or more improvement at 24 months compared to only 11.6% in the sham group.

Patients receiving ranibizumab had a threefold reduction in the probability of experiencing new proliferative events by month 36, indicating its efficacy in preventing disease progression in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ranibizumab Induces Regression of Diabetic Retinopathy in Most Patients at High Risk of Progression to Proliferative Diabetic Retinopathy. Wykoff, CC., Eichenbaum, DA., Roth, DB., et al.[2019]

Ranibizumab (Lucentis®) significantly improves visual acuity in patients with macular oedema following retinal vein occlusion, as shown in two phase III trials with monthly injections leading to better outcomes than sham injections at 6 months.

The treatment was generally well tolerated, with adverse events aligning with those seen in other conditions treated with ranibizumab, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ranibizumab: in macular oedema following retinal vein occlusion. Garnock-Jones, KP.[2021]

Intravitreal injections of ranibizumab (Lucentis) have been shown to be an effective and safe treatment option for macular edema caused by retinal vein occlusion, which is a major cause of vision impairment.

Compared to traditional treatments like laser photocoagulation or intravitreal triamcinolone, ranibizumab offers significant improvements in managing this condition, as supported by data from randomized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ranibizumab in Macular Edema following Retinal Vein Occlusion. Gallego-Pinazo, R., Dolz-Marco, R., Marín-Lambíes, C., et al.[2021]

The phase III BALATON/COMINO trials will assess the efficacy and safety of faricimab in treating diabetic macular edema due to retinal vein occlusion, involving 1282 patients across 22 countries.

Faricimab is being compared to aflibercept using a personalized treatment approach that adjusts dosing intervals based on individual patient responses, aiming to demonstrate noninferiority in visual acuity outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. Hattenbach, LO., Abreu, F., Arrisi, P., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05151744

NCT05151744 | A Study to Investigate Vamikibart ... Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula; Decreased visual acuity attributable primarily to DME; Ability ...

2. 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 ...

3. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/eye-disorder/dme/a-study-to-investigate-ro7200220-in-combination-with-ra-51781.html

Clinical Trial – Diabetic Macular Edema – Efficacy, Safet... Access the clinical trial testing efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7200220 in combination with ranibizumab ...

4. retinalphysician.com retinalphysician.com/issues/2025/june/clinical-trial-update/

Clinical Trial Update June 2025 Purpose: This study will evaluate the efficacy, safety, and pharmacokinetics of the PDS in participants with diabetic macular edema (DME) when ...

5. 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 ...

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] ...