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

Completed · Phase 2 · Has a placebo group

Conditions studied: Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00658619

Run by

Allergan

People needed

119

Starts

2008-05-01

Expected to finish

2011-04-08

Last updated by the study team

2018-08-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Geographic atrophy in both eyes due to age-related macular degeneration
• Visual acuity between 20/40 to 20/320

You may not qualify if…

• 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

Where it is running

• Study site — Abilene, Texas, United States
• Study site — Sydney, New South Wales, Australia
• Study site — Karlsruhe, Germany
• Study site — Udine, Italy
• Study site — Makati City, Philippines
• Study site — Coimbra, Portugal
• Study site — Seoul, South Korea

Full record on ClinicalTrials.gov

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