Phase 2
Completed N=21
An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
Source: ClinicalTrials.gov NCT00661479 ↗Enrolled (actual)
21
Serious AEs
9.5%
Results posted
Apr 2013
Primary outcomePrimary: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye — 48.5; 51.0; 52.7; 4.0 Number of Letters Read Correctly
Summary
This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
48.5; 51.0; 52.7; 4.0; 3.2; -1.3 | — |
| SECONDARY Change From Baseline in Contrast Sensitivity in the Study Eye |
15.5; 18.0; 22.3; 3.0; 0.8; -0.3 | — |
Eligibility Criteria
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 1
- Any ocular disease that can interfere with diagnosis and or assessment of disease progression
- Significant near-sightedness
- HIV
- Female patients who are pregnant, nursing, or planning pregnancy
Data sourced from ClinicalTrials.gov (NCT00661479). 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. Informational only — not medical advice.