Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular… (NCT02980874) | Clinical Trial Compass
TerminatedPhase 3
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Stopped: Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a corticosteroid together with an intravitreal anti-VEGF agent.
United States, Australia, Austria460 participantsStarted 2017-01-31
Plain-language summary
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.
Who can participate
Age range
18 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:
* Has a clinical diagnosis of RVO in the study eye
* Has a CST of ≥ 300 µm in the study eye
* Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye;
* Is naïve to local pharmacologic treatment for RVO in the study eye;
Exclusion Criteria:
* Any active ocular disease or infection in the study eye other than RVO
* History of glaucoma, intraocular pressure \> 21 mmHg or ocular hypertension requiring more than one medication
* Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
* Any evidence of neovascularization in the study eye
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)