A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With … (NCT05042609) | Clinical Trial Compass
CompletedPhase 3
A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
United States, France, Germany142 participantsStarted 2021-09-20
Plain-language summary
The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma
Who can participate
Age range
0 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At sites in the US: Male or female up to and including 75 years of age (including all pediatric age groups). At sites in the Europe: Male or female between 18 and 70 years of age, inclusive.
* Diagnosed with active non-infectious anterior uveitis with anterior chamber cell Grade 2 (6-15 cells) or Grade 3 (16-30 cells) in the study eye that are without any treatment or with Stable Medical Therapy requiring further treatment.
* Have Best Corrected Visual Acuity (BCVA) vision ≥ 65 letters in the non-study eye using Early Treatment Diabetic Retinopathy Study (ETDRS).
Exclusion Criteria:
* Pregnant or breastfeeding females or females.
* History of or active significant ocular disease in either eye.
* Uncontrolled intraocular pressure (IOP; defined as \>27mmHg) or narrow angle glaucoma in either eye and/or are at risk of angle closure with dilating.
* Poor posterior view due to limitation of dilation or media opacity that limits ability to examine the posterior segment.
* Cancer or melanoma that is actively treated with immunotherapy.
* Certain clinically significant systemic diseases or conditions.
* Receiving specific medication/interventions as specified per protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this Phase 3 trial is now completed, has the data been published yet, and what did the results show about whether TRS01 actually cleared or significantly reduced inflammation in the front of the eye by Day 28?
2The trial measured something called 'Anterior Chamber Cell Grade' reaching zero by Day 28 — can you explain what that grade means for my specific level of eye inflammation, and how realistic that 28-day target is for someone in my situation?
3This trial also included people with uveitic glaucoma, which I may have or be at risk for — how does treating uveitis with a drug like TRS01 potentially affect eye pressure, and is that something we'd need to monitor closely?
4Since this was a Phase 3 trial, which means it was testing effectiveness in a larger group, does the completed data suggest TRS01 performed better, worse, or about the same as existing treatments I might already be a candidate for?
5Given that this trial has already finished enrolling and completed, would any findings from it change your recommendation for how we should treat my non-infectious anterior uveitis right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anterior Chamber Cell (ACC) Grade = 0 on Day 28
Timeframe: 28 days
2
Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28