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Anti-VEGF inhibitor

Vamikibart + Ranibizumab for Diabetic Macular Edema

Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of diabetes mellitus (Type 1 or Type 2)
Decreased visual acuity attributable primarily to DME
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 44 and week 48
Awards & highlights

Study Summary

This trial is testing a new drug, RO7200220, to see if it's more effective than ranibizumab alone in treating diabetic macular edema. The study will last 76 weeks.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site in the eye, increased risk of eye infection or inflammation, possible changes in intraocular pressure, as well as general side effects such as headache or nausea related to systemic absorption.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with diabetes (Type 1 or Type 2).
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My vision loss is mainly due to diabetic macular edema.
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I have swelling in the center of my retina due to diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 44 and week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 44 and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
Secondary outcome measures
Change from Baseline in CST at Week 24
Change from Baseline in CST at Week 36
Change from Baseline in Central Subfield Thickness (CST) at Week 48
+19 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Vamikibart + RanibizumabExperimental Treatment2 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: RanibizumabActive Control2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ranibizumab
2017
Completed Phase 4
~2080

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,867 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,315 Total Patients Enrolled

Media Library

Ranibizumab (Anti-VEGF inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05151744 — Phase 2
Diabetic Macular Edema Research Study Groups: Arm A: Vamikibart + Ranibizumab, Arm B: Ranibizumab
Diabetic Macular Edema Clinical Trial 2023: Ranibizumab Highlights & Side Effects. Trial Name: NCT05151744 — Phase 2
Ranibizumab (Anti-VEGF inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05151744 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical trial currently accepting participants?

"This clinical trial is currently recruiting participants, having first been posted on December 17th 2021 and updated most recently on November 30th 2022. This information can be found on clinicaltrials.gov."

Answered by AI

Are there any analogous experiments that have used RO7200220?

"RO7200220 first came to the attention of researchers in 2008 at Ludwig Boltzmann Institute for Retinology and Biomicroscopic Lasersurgery. Since then, 334 trials have been concluded while 31 more are currently in progress across numerous locations, most notably The Woodlands, TX."

Answered by AI

What indications are being addressed through the utilization of RO7200220?

"RO7200220 is a typical remedy for branch vein occlusion and may be prescribed to treat wet age-related macular degeneration, macular edema, or myopic choroidal neovascularization."

Answered by AI

To what extent is involvement in this medical experiment being sought?

"To adequately test this medical intervention, 230 participants with pre-defined qualifications must partake in the trial. Selected patients can join from Retina Consultants of Texas located in The Woodlands, TX or from Texas Retina Associates situated in Arlington, MS."

Answered by AI

How many facilities are taking part in the experiment?

"At the moment, 14 different clinical locations are hosting this trial. These sites are located in The Woodlands, Arlington and Southaven as well as 11 other areas. To reduce travel costs and strain on participants, it is recommended to choose a facility near you for participation."

Answered by AI

Is RO7200220 a reliable and secure medication for patients?

"The safety of RO7200220 was appraised as a 2, given that Phase 2 trials provide some evidence for its security but no supportive data to vouch for efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Pinnacle Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema
2021. "A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05151744.
All > Macular Edema
~56 spots leftby Apr 2025
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