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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00972374 | Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function | PHASE2 | COMPLETED | 44 | — | — | Nov 1, 2009 | Jul 1, 2011 | Apr 24, 2013 | 6 | United States, India +4 |
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.
| Arm | Type | Description |
|---|---|---|
| 400 ug Brimonidine Implant | EXPERIMENTAL | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| 200 ug Brimonidine Implant | EXPERIMENTAL | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| Sham (no implant) | SHAM_COMPARATOR | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| Name | Type | Description |
|---|---|---|
| 400 ug Brimonidine Implant | DRUG | 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| 200 ug Brimonidine Implant | DRUG | 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye. |
| Sham (no implant) | OTHER | Sham Posterior Segment Drug Delivery system on Day 1 in the study eye. |
Inclusion Criteria: * The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology) * The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye * The repair must have been deemed an anatomic succe...