Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

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.

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