NCT02087085

A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration

Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Geographic Atrophy
• Macular Degeneration

Interventions

Type	Name	Description
DRUG	400 µg Brimonidine Implant	400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.
OTHER	Sham	Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.

Timeline

• Start date: 2014-05-09
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2014-03-14
• Last updated: 2019-04-23
• Results posted: 2019-04-23

Locations

41 sites across 6 countries: United States, Australia, France, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated drug study