RO7200220 for Diabetic Macular Edema

Recruiting at 55 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

394 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug RO7200220 for Diabetic Macular Edema?

The research mentions ranibizumab (Lucentis), which is part of the treatment being studied, and has been used effectively for macular edema in other conditions like retinal vein occlusion. This suggests it might also help with diabetic macular edema. ^{1 2 3 4 5}

What safety data exists for RO7200220 (Ranibizumab, Lucentis, Susvimo, Vamikibart, RG-6179) in humans?

Ranibizumab (also known as Lucentis) has been studied for safety in treating diabetic macular edema and other eye conditions. It has been shown to be safe in humans, with studies evaluating its use in conditions like diabetic macular edema and retinal vein occlusion. ^{3 6 7 8 9}

What is the purpose of this trial?

This trial tests vamikibart, an eye injection, in people with diabetic macular edema. The medication aims to reduce swelling and improve vision by being injected directly into the eye.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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]

References

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

Conbercept improves macular microcirculation and retinal blood supply in the treatment of nonischemic branch retinal vein occlusion macular edema. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Topical bromfenac reduces the frequency of intravitreal bevacizumab in patients with branch retinal vein occlusion. [2015]

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

Recurrence of macular edema in retinal vein occlusions after treatment with intravitreal ranibizumab (Lucentis). [2016]

4. England pubmed.ncbi.nlm.nih.gov

A retrospective study of the influence of the vitreomacular interface on macular oedema secondary to retinal vein occlusion. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Intravitreal bevacizumab for macular oedema secondary to branch retinal vein occlusion. [2015]

6. China pubmed.ncbi.nlm.nih.gov

Anatomical and functional changes after dexamethasone implant and ranibizumab in diabetic macular edema: a retrospective cohort study. [2020]

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

Pharmacokinetic evaluation of pegaptanib octasodium for the treatment of diabetic edema. [2016]

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

Pegaptanib sodium for macular edema secondary to branch retinal vein occlusion. [2016]

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

Intravitreal pegaptanib for refractory macular edema secondary to retinal vein occlusion. [2021]