RO7200220 for Diabetic Macular Edema
Recruiting at 55 trial locations
RS
Overseen ByReference Study ID Number: BP43445 https://forpatients.roche.com/
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Hoffmann-La Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
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.
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?
What safety data exists for RO7200220 (Ranibizumab, Lucentis, Susvimo, Vamikibart, RG-6179) in humans?
Research Team
CT
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
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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%
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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
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm C: 1.0 mg Vamikibart Q4WExperimental Treatment1 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 Q8WExperimental Treatment2 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 Q8WExperimental Treatment2 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 Q4WActive Control1 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.
Find a Clinic Near You
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]
References
Conbercept improves macular microcirculation and retinal blood supply in the treatment of nonischemic branch retinal vein occlusion macular edema. [2022]
Topical bromfenac reduces the frequency of intravitreal bevacizumab in patients with branch retinal vein occlusion. [2015]
Recurrence of macular edema in retinal vein occlusions after treatment with intravitreal ranibizumab (Lucentis). [2016]
A retrospective study of the influence of the vitreomacular interface on macular oedema secondary to retinal vein occlusion. [2018]
Intravitreal bevacizumab for macular oedema secondary to branch retinal vein occlusion. [2015]
Anatomical and functional changes after dexamethasone implant and ranibizumab in diabetic macular edema: a retrospective cohort study. [2020]
Pharmacokinetic evaluation of pegaptanib octasodium for the treatment of diabetic edema. [2016]
Pegaptanib sodium for macular edema secondary to branch retinal vein occlusion. [2016]
Intravitreal pegaptanib for refractory macular edema secondary to retinal vein occlusion. [2021]
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