Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculec… (NCT03766425) | Clinical Trial Compass
CompletedEarly Phase 1
Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.
Poland64 participantsStarted 2017-06-14
Plain-language summary
Comparison of efficacy and safety of Mitomycin and Aflibercept used to support primary trabeculectomy - a prospective, randomized trial in patients with open-angle glaucoma undergoing surgery.
Who can participate
Age range
40 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
. Primary open-angle glaucoma or capsular glaucoma.
. Patient's age: over 40 years, no sex preference;
. Local treatment ineffective due to:
. Intraocular pressure above 21mmHg at maximum pharmacological therapy (using β-blocker + carbonic anhydrase inhibitor + prostaglandins) or
. Intolerance to topical treatment or
. Progression in visual field examination
. Lack of previous ophthalmological surgical interventions.
. Lack of previously performed laser gonioplasty.
Exclusion criteria
. Patient with primary closed-angle glaucoma or secondary glaucoma (except for glaucoma in the course of pseudoexfoliation syndrome).
. One-eye patient.
. Patient with aphakia.
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
Effectiveness of aflibercept and mitomycin on the morphology of the bleb;
Timeframe: 1 year
2
Effectiveness of aflibercept and mitomycin on the function of the bleb;
. Patient after previous ophthalmic procedures (cataract removal by phacoemulsification with an implant of an intraocular lens, vitrectomy by pars plana, keratoplasty).
. A patient diagnosed or suspected of having uveitis or intraocular inflammation.
. Any corneal abnormalities or other conditions that prevent reliable testing with an applanation device in the treated eye, including earlier refractive surgery of the eye.