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

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.

Study Type: Interventional

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

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: Brimonidine Tartrate Implant
  • Stage 1: 200 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
• Drug: Brimonidine Tartrate Implant
  • Stage 1: 400 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
• Drug: Brimonidine Tartrate Implant
  • Stage 2: 200 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
• Drug: Brimonidine Tartrate Implant
  • Stage 2: 400 µg Brimonidine Tartrate Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in one eye and sham in fellow eye
• Drug: Sham
  • Sham Posterior Segment Drug Delivery system Applicator System at day 1 and month 6 in both eyes

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Stage 1: 200 µg Brimonidine Implant in one eye and sham in fellow eye
• Other: 2
  • Stage 1: 400 µg Brimonidine Implant in one eye and sham in fellow eye
• Other: 3
  • Stage 2: 200 µg Brimonidine Implant in one eye and sham in fellow eye
• Other: 4
  • Stage 2: 400 µg Brimonidine Implant in one eye and sham in fellow eye
• Sham Comparator: 5
  • Stage 2: sham in both eyes

Primary Measures

• Change from baseline in size of geographic atrophy based on the stereoscopic color fundus photography and fluorescein angiography.
  • Time Frame: Month 12
    Safety Issue?: No

Secondary Measures

• Visual acuity
  • Time Frame: Day 1 - Month 24
    Safety Issue?: No
• Contrast sensitivity
  • Time Frame: Day 1 - Month 24
    Safety Issue?: No
• Reading speed
  • Time Frame: Day 1 - Month 24
    Safety Issue?: No
• Patient questionnaires
  • Time Frame: Day 1 - Month 24
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Overall Contact: Allergan Inc  clinicaltrials@allergan.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00658619

Study ID Number: 190342-032D

ClinicalTrials.gov Identifier: NCT00658619

Health Authority: United States: Food and Drug Administration