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 range20 Years
SexALL
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.
What they're measuring
1
Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)