This study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
310
400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.
Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.
Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24
GA lesion area was measured in mm\^2 by FAF in the study eye and was quantified by the central reading center. The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard Best Correct Visual Acuity (BCVA). If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). Mixed model for repeated measures (MMRM) was used for analysis.
Time frame: Baseline (Day 1) to Month 24
Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24
BCVA was measured using an eye chart (ETDRS) and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.
Time frame: Baseline (Day 1) to Month 24
Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24
Low Luminance BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.
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Retinal Consultants of Arizona, Ltd., Retinal Research Institute
Phoenix, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
University of California, San Diego, Jacobs Retina Center, Shiley Eye Center
La Jolla, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, United States
"National Ophthalmic Research Institute Retina Consultants of Southwest Florida"
Fort Myers, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Southern Vitreoretinal Associates, PL
Tallahassee, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
...and 31 more locations
Time frame: Baseline (Day 1) to Month 24