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

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.

Timeline

Start

2014-05-09

Primary completion

2018-03-30

Completion

2018-03-30

Outcome

Met primary endpoint

registry analysis (superiority test); 400 µg Brimonidine Implant vs Sham; p = 0.047; Least Squares Mean Difference -0.3589 (95% CI -0.7132 to -0.0047); NCT02087085 ↗

Publications

• Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.
• Kuppermann BD, Patel SS, Boyer DS, Augustin AJ, Freeman WR, Kerr KJ, Guo Q, Schneider S, Lopez FJ; Brimo DDS Gen 1 Study Group. PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2021 Jan 1;41(1):144-155. doi: 10.1097/IAE.0000000000002789.

Drugs

Indications