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Monoclonal Antibodies
RO7200220 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
Decreased visual acuity attributable primarily to DME
Diagnosis of diabetes mellitus (Type 1 or Type 2)
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 for diabetic macular edema, a common complication of diabetes that can lead to blindness. The trial will last up to 76 weeks.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of Vamikibart aren't listed here, similar treatments often cause eye irritation or discomfort, increased intraocular pressure, bleeding inside the eye, cataract formation and sometimes infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My vision loss is mainly due to diabetic macular edema.
Select...
I have been diagnosed with diabetes (Type 1 or Type 2).
Select...
My diabetes has caused swelling in the center of my eye.
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 BCVA Over Time
Change From Baseline in CST Over Time
Change From Baseline in CST at Week 24
+19 moreTrial Design
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 Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,660 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,108 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never received Beovu® or received RO7200220 within the last 24 weeks.You have had implants called Iluvien or Retisert placed in your study eye within the past 3 years.I have a severe form of diabetic eye disease.I have an active eye infection or inflammation in my study eye.I don't have any eye conditions that could cause vision loss not related to DME.My vision loss is mainly due to diabetic macular edema.I haven't had anti-VEGF or Vabysmo treatments for my eye in the last 8 or 16 weeks, respectively.I have had laser treatment on my eye.My blood pressure is not higher than 180/100 mmHg while resting.I have been diagnosed with diabetes (Type 1 or Type 2).I haven't had steroid treatments near my eye in the last 16 weeks.My diabetes has caused swelling in the center of my eye.I have no eye conditions affecting my central vision other than DME.
Research Study Groups:
This trial has the following groups:- Group 1: Arm D: 0.5 mg Ranibizumab Q4W
- Group 2: Arm C: 1.0 mg Vamikibart Q4W
- Group 3: Arm A: 0.25 mg Vamikibart Q8W
- Group 4: Arm B: 1.0 mg Vamikibart Q8W
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.
Diabetic Macular Edema Patient Testimony for trial: Trial Name: NCT05151731 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there various locales in the city conducting this experiment?
"This trial is presently being conducted at 41 different sites, including those in San Antonio, The Woodlands and Boisbriand. To reduce travel time for prospective participants it is recommended to choose the closest clinic to your residence if you decide to join this study."
Answered by AI
What are the primary applications of RO7200220?
"RO7200220 is a viable treatment for branch vein occlusion, wet age-related macular degeneration (wAMD), and macular edema."
Answered by AI
Is enrollment for this trial available to the public?
"Indeed, current records on clinicaltrials.gov show that this medical study began recruiting patients on December 31st 2021 and was last modified November 30th 2022. The survey aims to enlist 400 individuals from across 41 distinct centres."
Answered by AI
Are there any other trials that have been conducted regarding RO7200220's efficacy?
"Currently, 31 clinical trials are examining the effects of RO7200220 and 15 have advanced to Phase 3. Most research is taking place in Oak Forest, Illinois; however, 814 locations across the US also host studies dedicated to this drug."
Answered by AI
Is RO7200220 a viable and safe treatment option?
"RO7200220's safety rating is 2 due to the fact that this Phase 2 clinical trial has provided some evidence of its security, but none regarding efficacy."
Answered by AI
How many subjects are participating in this investigation?
"This clinical trial calls for 400 individuals who meet the established eligibility requirements. Those interested can take part at Medical Center Ophthalmology Associates in San Antonio, Texas or Retina Consultants of Texas in The Woodlands, Quebec."
Answered by AI
Who else is applying?
What state do they live in?
New York
Florida
How old are they?
18 - 65
What site did they apply to?
Opthalmic Consultants of LI
Florida Retina Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I need any help that may improve my vision, very fustrated. Looking for a trial for Macular Edema as I have no insurance and probably only way I'll get treated. I also hope the trial succeeds so others can be saved.
PatientReceived no prior treatments
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