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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00661479 | An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa | PHASE1 | COMPLETED | 21 | — | — | Jul 1, 2008 | May 1, 2010 | Apr 24, 2013 | 4 | United States, France +2 |
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
| Arm | Type | Description |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant Group B | EXPERIMENTAL | 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 200 µg Brimonidine Tartrate Implant Group B | EXPERIMENTAL | 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 100 µg Brimonidine Tartrate Implant Group B | EXPERIMENTAL | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| 100 µg Brimonidine Tartrate Implant Group A | EXPERIMENTAL | 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1. |
| Name | Type | Description |
|---|---|---|
| 400 µg Brimonidine Tartrate Implant | DRUG | 400 µg brimonidine tartrate implant in the study eye on Day 1. |
| 200 µg Brimonidine Tartrate Implant | DRUG | 200 µg brimonidine tartrate implant in the study eye on Day 1. |
| 100 µg Brimonidine Tartrate Implant | DRUG | 100 µg brimonidine tartrate implant in the study eye on Day 1. |
| Sham (no implant) | OTHER | Sham in the fellow eye on Day 1. |
Inclusion Criteria: * Retinitis Pigmentosa in both eyes * Visual acuity between 20/40 to count fingers Exclusion Criteria: * Growth of new blood vessels in the eye * Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day...