Clinical Trial: Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) With Placebo for the Treatment of
Brief Summary: The purpose of this study is to determine if emixustat hydrochloride (ACU-4429) reduces the rate of progression of geographic atrophy compared to placebo in subjects with dry age-related macular degeneration.
Detailed Summary:
Sponsor: Acucela Inc.
Current Primary Outcome: Change from baseline in the total area of the GA lesion(s) [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in BCVA score [ Time Frame: 24 months ]
- Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs [ Time Frame: 24 months ]
Original Secondary Outcome: Same as current
Information By: Acucela Inc.
Dates:
Date Received: February 28, 2013
Date Started: February 2013
Date Completion:
Last Updated: May 31, 2016
Last Verified: May 2016
