Phase 3
N=172
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Symptomatic Vitreomacular Adhesion
Bottom Line
View on ClinicalTrials.gov: NCT01889251 ↗Enrolled (actual)
172
Serious AEs
15.7%
Results posted
Oct 2015
Primary outcome: Primary: Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) — 52.2; 1.8 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ocriplasmin (Drug); Sham injection (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA) |
52.2; 1.8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01889251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.