Overview

This trial is active, not recruiting.

Conditions geographic atrophy, macular degeneration
Treatments 400 µg brimonidine implant, sham
Phase phase 2
Sponsor Allergan
Start date May 2016
End date September 2018
Trial size 311 participants
Trial identifier NCT02087085, 190342-038, 2013-003320-36

Summary

This study will assess the safety and efficacy of the brimonidine intravitreal implant in patients with geographic atrophy due to age-related macular degeneration.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
400 µg brimonidine implant in the study eye on Day 1, and every 3 months through Month 21.
400 µg brimonidine implant
400 µg brimonidine implant in the study eye on Day 1, and every 3 months through Month 21.
(Sham Comparator)
Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.
sham
Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.

Primary Outcomes

Measure
Change from Baseline in Atrophic Lesion Area in the Study Eye
time frame: Baseline, Month 24

Secondary Outcomes

Measure
Change from Baseline in Low Luminance Best Corrected Visual Acuity (BCVA) in the Study Eye
time frame: Baseline, Month 24
Change from Baseline in BCVA in the Study Eye
time frame: Baseline, Month 24

Eligibility Criteria

Male or female participants at least 55 years old.

Inclusion Criteria: - Geographic atrophy due to age-related macular degeneration in the study eye - Visual acuity better than or equal to 20/125 in the study eye and 20/200 in the fellow eye Exclusion Criteria: - Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in the last 3 months - Infections in either eye in the last 3 months

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Allergan.