Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01889251 | A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion | PHASE3 | COMPLETED | 251 | — | — | Jul 1, 2013 | Sep 1, 2014 | Nov 30, 2015 | 1 | Japan |
VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.
| Arm | Type | Description |
|---|---|---|
| Ocriplasmin | EXPERIMENTAL | Ocriplasmin administered as a single intravitreal injection to the study eye at baseline |
| Sham injection | SHAM_COMPARATOR | Single sham injection to the study eye at baseline |
| Name | Type | Description |
|---|---|---|
| Ocriplasmin | DRUG | - |
| Sham injection | DRUG | - |
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 co...