Conditions: Geographic Atrophy
Keywords: Geographic Atrophy Age-Related Macular Degeneration Intravitreal injection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 1 intravitreal injection per month for up to 12 months arm 2: 1 mock injection per month for 12 months

Interventions: intervention 1: Al-78898A intervention 2: Sham injection
Intervention descriptions: intervention 1: 0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection intervention 2: Mock injection administered as an empty hub without needle

Protocol document: