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Vamikibart for Uveitic Macular Edema (Sandcat 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 up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial will test a new drug to help people with swelling in the middle of their eye caused by inflammation.
Who is the study for?
This trial is for women with uveitic macular edema, which causes swelling in the eye. They must have a certain level of vision impairment and agree to use contraception or abstain from sex. Those with recent major eye surgeries, infections like syphilis or tuberculosis, HIV, uncontrolled glaucoma, or who've used certain medications recently can't join.
What is being tested?
The study tests Vamikibart's effectiveness and safety against uveitic macular edema compared to a sham treatment (placebo). Participants will be randomly assigned to receive either Vamikibart or the sham intervention to see if there's an improvement in their condition.
What are the potential side effects?
While specific side effects of Vamikibart are not listed here, similar treatments may cause eye irritation or redness, increased intraocular pressure, cataract formation, and potential risk of infection due to immune system suppression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm BExperimental Treatment1 Intervention
Participants will receive 4 low-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 high-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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vamikibart
2021
Completed Phase 2
~590
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,457 Previous Clinical Trials
1,097,487 Total Patients Enrolled
17 Trials studying Macular Edema
14,798 Patients Enrolled for Macular Edema
Clinical TrialsStudy DirectorHoffmann-LaRoche
2,227 Previous Clinical Trials
896,177 Total Patients Enrolled
18 Trials studying Macular Edema
14,605 Patients Enrolled for Macular Edema
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have swelling in the back of my eye not caused by inflammation.I have no eye conditions blocking the view or imaging of my retina.I have a serious ongoing health or mental health condition.I have swelling in the eye due to non-infectious inflammation.I have an eye condition that might need treatment to prevent losing my sight during the study.I have uncontrolled eye pressure or glaucoma, or my eye pressure is too low.I have tuberculosis or HIV.I have had major eye or other surgeries.I haven't had certain eye injections in the last 2-4 months.I haven't had macular laser therapy, cataract surgery in the last 6 months, or laser capsulotomy in the last 3 months.I agree to follow the study's rules on abstinence or contraception.I have been diagnosed with a type of uveitis, regardless of its activity level or part of the eye it affects.I haven't used certain eye treatments before the trial starts.
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.
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