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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 weeks 20 and 52
Awards & highlights
Sandcat 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.Check my eligibility
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.See study design
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.
Sandcat 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
+18 moreSandcat 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
1,090,098 Total Patients Enrolled
1 Trials studying Uveitic Macular Edema
225 Patients Enrolled for Uveitic Macular Edema
Clinical TrialsStudy DirectorHoffmann-LaRoche
2,201 Previous Clinical Trials
888,815 Total Patients Enrolled
1 Trials studying Uveitic Macular Edema
225 Patients Enrolled for Uveitic 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How secure is Arm A for participants?
"Our internal assessment at Power ranked Arm A's safety as a 3 due to the Phase 3 trial data that shows efficacy and multiple rounds of evidence-based security."
Answered by AI
Are patient enrollments still open for this particular research study?
"Yes, per the resources on clinicaltrials.gov this study is actively enrolling patients. It was first announced in March 10th 2023 and has been updated as recently as 3/3/2023. 225 participants are needed from 2 medical centres to complete the trial."
Answered by AI
How many participants are being recruited for this trial?
"Affirmative. Clinicaltrials.gov reveals that this investigation is currently looking for qualified individuals, with the initial posting taking place on March 10th 2023 and a subsequent update occurring 3/3/2023. A total of 225 candidates are required at two distinct medical facilities."
Answered by AI
Who else is applying?
What site did they apply to?
Barnet Dulaney Perkins Eye Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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