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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Brimonidine Tartrate

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