A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Unnamed facility
Artesia, California, United States
Unnamed facility
Tel Aviv, Israel
Percentage of Patients With a Visual Field Improvement in the Study Eye
Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.
Time frame: Baseline, Month 6
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 6
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