Status:
COMPLETED
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Lead Sponsor:
Allergan
Conditions:
Rhegmatogenous Macula-off Retinal Detachment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00972374
Start Date
November 1 2009
End Date
July 1 2011
Last Update
April 24 2013
Active Locations (6)
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1
Abilene, Texas, United States
2
New Delhi, India
3
Tel Aviv, Israel
4
Makati, Philippines