Abstract
Purpose :
To report demographic data and assess the safety of daily oral administration of
ORACEA® compared with daily oral administration of placebo in subjects with
geographic atrophy due to non-exudative age-related macular degeneration (AMD).
Methods :
Multicenter, randomized, double-masked, placebo controlled study. After eligibility,
participants were randomized in a 1:1 ratio to either the ORACEA® treatment group or
placebo treatment group. During the 24-month Treatment Period (Day 0- Month 24)
subjects returned for follow-up study visits every 6 months at Month 6, 12, 18 and 24 (±
30 days). 30 days (± 7 days) after completion of the Month 24 visit, participants were
asked to return for an End-of-Study Follow-up visit.
Results :
A total of 276 participants (156 female, 115 male, and 5 not reported) were enrolled. 55
of the 276 participants completed the study though 30 months. The mean patient age at
the time of enrollment was 77.8 years (SD ±8.64, range 38-100). Nine patients were
current smokers, 121 were former smokers, 107 never smoked, 32 had unknown smoking
history, and 17 did not report smoking status. 276 patients were Caucasian, 1 was
Hispanic, 1 was African America, 7 were unknown ethnicity, and 7 did not report
ethnicity. Mean area of geographic atrophy at baseline was 7.73 micrometers (SD ±4.27,
range 1.38-18.65). Mean area of geographic atrophy at 6-months was 7.99 micrometers
(SD ±4.23, range 1.75-19.19). Mean area of geographic atrophy at 18-months was 9.58
micrometers (SD ±4.88, range 2.42-22.58). Mean area of geographic atrophy at 30-
months was 10.98 micrometers (SD ±5.41, range 2.63-25.74).
Conclusions :
Based on preliminary data, ORACEA® appears to be safe and well tolerated.
ORACEA® may be potentially helpful in hindering progression of geographic atrophy in
non-exudative AMD. Further evaluation of the efficacy of the medication is currently
being conducted.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.