Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Functio
- Registration Number
- CTRI/2010/091/000257
- Lead Sponsor
- Allergan, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 99
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best Corrected Visual Acuity (BCVA)Timepoint: Month 3
- Secondary Outcome Measures
Name Time Method Mean BCVA change from baselineTimepoint: Month 3