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Vamikibart for Uveitic Macular Edema (Meerkat Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 20 and 52
Awards & highlights
Meerkat Trial Summary
This trial tests a new drug to treat swelling in the back of the eye that can cause vision loss.
Who is the study for?
This trial is for people with uveitic macular edema, a type of eye swelling. Participants must have certain vision scores and agree to use contraception or abstain from sex if female. They can't join if they've had recent eye treatments, other major eye conditions, systemic infections like syphilis or tuberculosis, HIV, uncontrolled glaucoma, or used specific medications recently.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Vamikibart in treating uveitic macular edema compared to a sham treatment (placebo). It aims to see how well Vamikibart works and monitors any side effects that occur during the trial.See study design
What are the potential side effects?
While not specified here, potential side effects may include typical drug reactions such as irritation at the injection site, changes in vision, increased intraocular pressure, headache or allergic reactions. The exact side effects will be monitored throughout the study.
Meerkat Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 20 and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 20 and 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Secondary outcome measures
Anti-drug antibody titer to vamikibart
Aqueous humor (AH) concentration of vamikibart
Change from Baseline in BCVA at Weeks 20 and 52
+19 moreMeerkat Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm BExperimental Treatment1 Intervention
Participants will receive 4 high-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48.
Group II: Arm AExperimental Treatment1 Intervention
Participants will receive 4 low-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48.
Group III: Arm CPlacebo Group1 Intervention
Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,998 Total Patients Enrolled
1 Trials studying Uveitic Macular Edema
225 Patients Enrolled for Uveitic Macular Edema
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,715 Total Patients Enrolled
1 Trials studying Uveitic Macular Edema
225 Patients Enrolled for Uveitic Macular Edema
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had certain eye injections in the last 2-4 months.I have had major eye or other surgeries.I haven't had macular laser therapy, cataract surgery in the last 6 months, or laser capsulotomy in the last 3 months.I have serious eye conditions that might need treatment to prevent losing my sight during the study.I have no eye conditions blocking the view or imaging of my retina.I agree to follow the study's rules on abstinence or contraception.I have had tuberculosis or HIV.I have uncontrolled eye pressure or glaucoma.I have swelling in the eye due to non-infectious uveitis.I have swelling in the back of my eye not caused by inflammation.I haven't used certain eye treatments before the trial starts.I have been diagnosed with a type of uveitis, regardless of its activity level or part of the eye it affects.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
- Group 3: Arm C
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent can Arm A pose a hazard to people?
"The risk profile of Arm A was assessed as a 3, stemming from the Phase 3 trial status and evidence-based corroboration that its efficacy is supported by sufficient data."
Answered by AI
Does this research project presently require participants?
"Clinicaltrials.gov indicates that this investigation is actively seeking participants; the initial advertisement was published on January 13th 2023 and was last revised on January 6th 2023."
Answered by AI
What is the cap on the number of participants in this experiment?
"Hoffmann-La Roche is overseeing the trial from Erie Retinal Surgery in Pennsylvania and Texas Retina Associates in Dallas. The experiment necessitates 225 qualified participants to commence."
Answered by AI
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