Status:
COMPLETED
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Lead Sponsor:
Alcon Research
Conditions:
Symptomatic Vitreomacular Adhesion
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 subj...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT01889251
Start Date
July 1 2013
End Date
September 1 2014
Last Update
November 30 2015
Active Locations (1)
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1
Contact Alcon for Trial Locations
Tokyo, Japan