Clinical Trial: An Epidemiologic Study of Disease Progression in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (Proxima B)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A MULTICENTER, PROSPECTIVE EPIDEMIOLOGIC STUDY OF THE PROGRESSION OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION
Brief Summary: This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study also will generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling patients with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 60 months.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Change in the GA area, as assessed by retinal imaging [ Time Frame: From Baseline over time(every 6 months) to end of study, up to 60 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in additional measures of visual function [ Time Frame: From Baseline over time (every 6 months) to end of study, up to 60 months ]
- Best Corrected Visual Acuity (BCVA) score as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart under low luminance conditions [ Time Frame: From Baseline over time (every 6 months) to end of study, up to 60 months ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: March 23, 2015
Date Started: March 31, 2015
Date Completion: May 31, 2022
Last Updated: May 9, 2017
Last Verified: May 2017
