Conditions: Macular Degeneration
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 119
Healthy volunteers: no

Brief summary:
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.

Detailed description:

Arms:
arm 1: Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. arm 2: Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. arm 3: Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. arm 4: Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. arm 5: Stage 2: sham in both eyes on Day 1 and Month 6.

Interventions: intervention 1: 400 µg Brimonidine Tartrate Implant intervention 2: 200 µg Brimonidine Tartrate Implant intervention 3: Sham (no implant)
Intervention descriptions: intervention 1: 400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. intervention 2: 200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. intervention 3: Sham in one or both eyes on Day 1 and Month 6.

Protocol document: