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

Condition(s) targeted: Macular Degeneration

Intervention: Brimonidine Tartrate Implant (Drug); Brimonidine Tartrate Implant (Drug); Brimonidine Tartrate Implant (Drug); Brimonidine Tartrate Implant (Drug); Sham (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com

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.

Official title: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in size of geographic atrophy based on the stereoscopic color fundus photography and fluorescein angiography.

Secondary outcome:

Visual acuity

Contrast sensitivity

Reading speed

Patient questionnaires

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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

Allergan Inc, Email: clinicaltrials@allergan.com

Korea, Korea, Republic of; Not yet recruiting

Abilene, Texas, United States; Recruiting

Starting date: May 2008
Ending date: December 2011
Last updated: September 10, 2008