Your session is about to expire
← Back to Search
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 belowSelect...
I have been diagnosed with diabetes (Type 1 or Type 2).
Select...
My vision loss is mainly due to diabetic macular edema.
Select...
I have swelling in the center of my retina due to diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 44 and week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 44 and week 48
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 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Diabetic Macular Edema (DME) involve anti-VEGF therapies, such as ranibizumab, which inhibit the vascular endothelial growth factor (VEGF). VEGF promotes the growth of abnormal blood vessels in the retina, leading to fluid leakage and swelling in the macula.
By blocking VEGF, these treatments reduce macular edema and improve vision. Vamikibart, currently being studied in combination with ranibizumab, may enhance the effects of anti-VEGF therapy, offering potentially greater reductions in macular edema and better visual outcomes.
This is vital for DME patients as it directly targets the cause of vision impairment, aiming to preserve and improve their quality of life.
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,205 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,849 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never received Beovu® or received vamikibart within the last 24 weeks.I have been diagnosed with diabetes (Type 1 or Type 2).My vision loss is mainly due to diabetic macular edema.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.I haven't had anti-VEGF or Vabysmo treatments for my eye in the last 8 and 16 weeks respectively, and I've never used Beovu.I have had laser treatment on my eye.I have an active eye infection or inflammation in my study eye.I haven't had steroid treatments for my eye in the last 16 weeks.I have swelling in the center of my retina due to diabetes.I have a type of eye damage from diabetes that affects my vision.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Vamikibart + Ranibizumab
- Group 2: Arm B: Ranibizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger