Phase 2
Completed N=44
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Rhegmatogenous Macula-off Retinal Detachment
Source: ClinicalTrials.gov NCT00972374 ↗
Enrolled (actual)
44
Serious AEs
9.1%
Results posted
Apr 2013
Primary outcomePrimary: Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye — 6.7; 6.7; 0 Percentage of Patients
Summary
This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
6.7; 6.7; 0 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |
46.6; 53.3; 50.3; 6.0; 3.1; 4.8 | — |
Eligibility Criteria
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 success and required no more than one macular re-attachment procedure
- The visual acuity score must be between 20/50 and 20/320 in the study eye
Exclusion Criteria
- Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
- Anticipated need for ocular surgery during the 12-month study period
- Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
- Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
- Any infectious condition in the study eye
Data sourced from ClinicalTrials.gov (NCT00972374). 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.