Conditions: Glaucoma, Open-Angle
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. arm 2: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. arm 3: Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Interventions: intervention 1: 400 ug Brimonidine Implant intervention 2: 200 ug Brimonidine Implant intervention 3: Sham (no implant)
Intervention descriptions: intervention 1: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. intervention 2: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye. intervention 3: Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Protocol document: