Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Completed · Phase 2 · Has a placebo group
Conditions studied: Rhegmatogenous Macula-off Retinal Detachment
In brief
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.
Key facts
- Study ID
- NCT00972374
- Run by
- Allergan
- People needed
- 44
- Starts
- 2009-11-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2013-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Abilene, Texas, United States
- Study site — New Delhi, India
- Study site — Tel Aviv, Israel
- Study site — Makati, Philippines
- Study site — Seoul, South Korea
- Study site — London, United Kingdom
Full record on ClinicalTrials.gov
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