Phase 2 N=44 Randomized Triple-blind Treatment

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

Rhegmatogenous Macula-off Retinal Detachment

Bottom Line

View on ClinicalTrials.gov: NCT00972374 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Apr 2013

Primary outcome: Primary: Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye — 6.7; 6.7; 0 Percentage of Patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 400 ug Brimonidine Implant (Drug); 200 ug Brimonidine Implant (Drug); Sham (no implant) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Oct 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	6.7; 6.7; 0	—
SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	46.6; 53.3; 50.3; 6.0; 3.1; 4.8	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00972374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.