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Amber Lewis, Ilona Kravtsova, Kevin Kerr, Yan Li, Werner Schmidt, Francisco López; Does Brimonidine DDS Reduce the Geographic Atrophy Lesion Perimeter Hyperautofluorescence Over Time?. Invest. Ophthalmol. Vis. Sci. 2019;60(9):359.
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© ARVO (1962-2015); The Authors (2016-present)
Presence of hyperautofluorescence (HAF) on fundus autofluorescence (FAF) images is associated with faster progression of geographic atrophy (GA) secondary to age-related macular degeneration. However, HAF is not currently used as an anatomic endpoint in clinical studies. In this retrospective analysis of a phase 2a study evaluating Brimonidine DDS versus sham procedure, we assessed the percent of GA lesion perimeter bordering areas of HAF over time (percent HAF perimeter).
FAF images of a subset of participants (n=34) with GA from a global, multicenter, phase 2a study of Brimonidine DDS vs sham procedure (NCT00658619) were included in this retrospective analysis. GA lesion perimeters were measured from FAF images using ImageJ software (v1.52a). In addition, the total length of segments bordering areas of HAF were measured with the segmented line tool in ImageJ. Summary statistics for the percent HAF perimeter were generated using R Software (v3.5.1) under R Studio. Linear mixed effects model with treatment and time as fixed effects and baseline as well as baseline time interaction as covariates evaluated change from baseline in the percent HAF perimeter using SAS (v9.4).
Baseline percent HAF perimeter [mean (SEM)] was 11.8% (5.6) in the sham group (n=8), 23.7% (6.8) in the Brimonidine DDS 132 µg group (n=14) and 13.1% (4.9) in the Brimonidine DDS 264 µg group (n=12). At Month 12, the baseline-corrected change from baseline in percent HAF perimeter [least squared mean (SE)] was -1.7% (6.1), 2.8% (4.8), and -5.8% (5.3) for the sham procedure, Brimonidine DDS 132 µg, and 264 µg groups respectively. At Month 24, the change from baseline in percent HAF perimeter was even more pronounced at -5.1% (6.8), -4.8% (5.3), and -12.2% (6.1) for the sham procedure, Brimonidine DDS 132 µg, and 264 µg groups, respectively.
Although this study is limited by a very small sample size, these data suggest that Brimonidine DDS may reduce the percent HAF perimeter in patients with GA. If confirmed in larger datasets, change from baseline in percent HAF perimeter may be a useful measurement in clinical studies to assess the efficacy of therapeutic agents for GA.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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