A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion (NCT01889251) | Clinical Trial Compass
CompletedPhase 3
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Japan251 participantsStarted 2013-07
Plain-language summary
The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.
Who can participate
Age range
20 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:
* Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
* Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
* BCVA of 20/800 or better in the non-study eye;
* Provide written informed consent;
* Follow specified instructions during study period;
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
* Vitreous hemorrhage or other opacification;
* High myopia in the study eye;
* Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
* Uncontrolled glaucoma in the study eye;
* History of retinal detachment in either eye;
* Active infection in either eye;
* Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;
* Participation in another investigational drug study within 30 days prior to this study;
* Other protocol-defined exclusion criteria may apply.
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 With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)