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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
44
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
Unnamed facility
Abilene, Texas, United States
Unnamed facility
New Delhi, India
Unnamed facility
Tel Aviv, Israel
Unnamed facility
Makati, Philippines
Unnamed facility
Seoul, South Korea
Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.
Time frame: Month 3
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Time frame: Baseline, Month 3
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Unnamed facility
London, United Kingdom