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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Multicenter, Randomized, Single-Masked, Sham-Controlled, Proof-of-Concept Study of Intravitreal AL-78898A in Patients With Bilateral Geographic Atrophy (GA) Associated W

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 Summary: 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.
Sponsor: Alcon Research

Current Primary Outcome: Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging [ Time Frame: Day 0 (injection visit), 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.


Original Primary Outcome: Mean GA lesion size change from baseline at Month 12 as measured by fundus autofluorescence (FAF) [ Time Frame: 12 months ]

Current Secondary Outcome:

  • Yearly GA Lesion Size Growth Rate [ Time Frame: Baseline (Day 0), up to 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.
  • Mean Change From Baseline in BCVA at Month 12 [ Time Frame: Baseline (Day 0), 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.


Original Secondary Outcome: effect of repeat IVT doses of AL-78898A on best-corrected visual acuity (BCVA) [ Time Frame: 12 months ]

Information By: Alcon Research

Dates:
Date Received: May 18, 2012
Date Started: June 2012
Date Completion:
Last Updated: December 3, 2013
Last Verified: December 2013