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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01080209 | Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System | PHASE2 | COMPLETED | 215 | — | — | Feb 1, 2010 | Feb 1, 2014 | Feb 20, 2015 | 13 | United States, Australia +10 |
Implants administered during the parent study are evaluated during this study to determine if they have completely degraded. The time frame is evaluated from the point of the first treatment in the parent study.
| Arm | Type | Description |
|---|---|---|
| Brimo PS DDS® 400 μg (2 implants) | EXPERIMENTAL | Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study. |
| Brimo PS DDS® 400 μg (1 implant) | EXPERIMENTAL | Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study. |
| Brimo PS DDS® 200 μg (2 implants) | EXPERIMENTAL | Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study. |
| Brimo PS DDS® 200 μg (1 implant) | EXPERIMENTAL | Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study. |
| Brimo PS DDS® 100 μg (1 implant) | EXPERIMENTAL | Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study. |
| Brimo PS DDS® 50 μg (1 implant) | EXPERIMENTAL | Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study. |
| Sham | SHAM_COMPARATOR | Patients who received sham in a previous study. |
| Name | Type | Description |
|---|---|---|
| Brimo PS DDS® | DRUG | Patients who received Brimo PS DDS® intravitreal implant in a previous study. |
| Sham | OTHER | Patients who recieved sham in a previous study. |
Inclusion Criteria: * Received the most recent sham or active study treatment of intravitreal Brimo PS DDS® no later than 36 months prior to entry into this study and have either completed their previous study, or have exited early from their previous study for any reason * Applicable studies: Prev...