Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving V… (NCT00972374) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
United States, India, Israel44 participantsStarted 2009-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye