Clinical Trial: Geographic Atrophy Treatment Evaluation

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

Official Title: The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Brief Summary: The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Detailed Summary:
Sponsor: Alcon Research

Current Primary Outcome: Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging [ Time Frame: Baseline, up to Month 30 ]

The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.


Original Primary Outcome: Mean annualized atrophic lesion growth [ Time Frame: 24 months ]

Current Secondary Outcome:

Original Secondary Outcome: Visual acuity [ Time Frame: 24 months ]

Information By: Alcon Research

Dates:
Date Received: April 27, 2009
Date Started: April 2009
Date Completion:
Last Updated: June 4, 2014
Last Verified: June 2014