The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT) injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size change from baseline at Month 12.
Participants meeting inclusion/exclusion criteria were randomized in a 2:1 ratio to receive AL-78898A or a sham injection. The study eye was assessed before and after each injection to ensure that the injection procedure and/or study medication had not endangered the health of the eye. The Investigator determined each month whether the patient was eligible to receive the next injection. The study was terminated due to a high likelihood that continued enrollment would reach the predefined study stopping criteria based upon the number of patients with drug deposit formation, which made an assessment of efficacy futile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection
Mock injection administered as an empty hub without needle
Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging
Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.
Time frame: Day 0 (injection visit), Month 12
Yearly GA Lesion Size Growth Rate
Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.
Time frame: Baseline (Day 0), up to Month 12
Mean Change From Baseline in BCVA at Month 12
Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.
Time frame: Baseline (Day 0), Month 12
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