Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)

• Status: Completed
• Trial end date: 2011-04-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Brimonidine Tartrate

Criteria

Inclusion Criteria:

• Geographic atrophy in both eyes due to age-related macular degeneration

• Visual acuity between 20/40 to 20/320

Exclusion Criteria:

• Known allergy to brimonidine

• Uncontrolled systemic disease or infection of the eye

• Recent eye surgery or injections in the eye

• Female patients who are pregnant, nursing or planning a pregnancy