NCT01603043

A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)

A Multicenter, Randomized, Single-Masked, Sham-Controlled, Proof-of-Concept Study of Intravitreal AL-78898A in Patients With Bilateral Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	Al-78898A	0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection
DRUG	Sham injection	Mock injection administered as an empty hub without needle

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-05-22
• Last updated: 2014-01-20
• Results posted: 2014-01-20