Vamikibart + Ranibizumab for Diabetic Macular Edema

Recruiting at 61 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

187 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, vamikibart, combined with an existing treatment, ranibizumab, in people with diabetic macular edema. The goal is to better control fluid buildup in the eye and improve vision.

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.

What data supports the effectiveness of the drug Ranibizumab for Diabetic Macular Edema?

Research shows that Ranibizumab is effective in improving vision in patients with macular edema due to retinal vein occlusion, which is similar to diabetic macular edema. It has been shown to improve visual acuity and reduce retinal thickness, indicating its potential effectiveness for diabetic macular edema as well. ^{1 2 3 4 5}

Is the treatment with Ranibizumab generally safe for humans?

Research shows that Ranibizumab (also known as Lucentis) is considered a safe option for treating eye conditions like macular edema due to retinal vein occlusion, based on clinical trials and real-world evidence. ^{1 3 5 6 7}

How is the drug Vamikibart + Ranibizumab unique for treating diabetic macular edema?

The combination of Vamikibart and Ranibizumab for diabetic macular edema is unique because it potentially offers a novel approach by combining two agents, where Ranibizumab is already known for its effectiveness in treating macular edema by inhibiting a protein that causes abnormal blood vessel growth in the eye. This combination could enhance treatment efficacy or provide additional benefits compared to using Ranibizumab alone. ^{1 3 4 8 9}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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 (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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ranibizumab in Macular Edema following Retinal Vein Occlusion. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Ranibizumab Induces Regression of Diabetic Retinopathy in Most Patients at High Risk of Progression to Proliferative Diabetic Retinopathy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Intravitreal ranibizumab for macular oedema secondary to retinal vein occlusion: a retrospective study of 34 eyes. [2015]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Ranibizumab: in macular oedema following retinal vein occlusion. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of Ranibizumab and Bevacizumab for Macular Edema Secondary to Retinal Vein Occlusions in Routine Clinical Practice. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of anti-vascular endothelial growth factor (VEGF) therapy with intravitreal ranibizumab (Lucentis) for naive retinal vein occlusion: 1-year follow-up. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Innovator Versus Biosimilar Ranibizumab in Polypoidal Choroidal Vasculopathy: Real-World Evidence. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

BALATON and COMINO: Phase III Randomized Clinical Trials of Faricimab for Retinal Vein Occlusion: Study Design and Rationale. [2023]

9. Japan pubmed.ncbi.nlm.nih.gov

Comparison between ranibizumab and aflibercept for macular edema associated with central retinal vein occlusion. [2018]