Clinical Trial: An Epidemiologic Study of Disease Progression in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (Proxima A).

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Epidemiologic Study of Disease Progression in Patients With 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 is also intended to 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 48 months. There is a planned interim analysis around the 2 year time window for the study.

Detailed Summary:
Sponsor: Hoffmann-La Roche

Current Primary Outcome:

  • Macular functional response as assessed by mesopic microperimetry (MP) [ Time Frame: From Baseline over time (every 12 months) to end of study, up to 48 months ]
  • Binocular reading speed as assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards [ Time Frame: From Baseline over time (every 6 months) to end of study, up to 48 months ]
  • Best Corrected Visual Acuity (BCVA) 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 48 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in the Geographic Atrophy (GA) area, as assessed by retinal imaging [ Time Frame: From Baseline over time (every 6 months) to end of study, up to 48 months ]
  • Change over time in selected patient-reported outcomes, as assessed by the National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) [ Time Frame: From Baseline over time (every 6 months) to end of study, up to 48 months ]


Original Secondary Outcome: Same as current

Information By: Hoffmann-La Roche

Dates:
Date Received: June 19, 2015
Date Started: June 30, 2015
Date Completion: May 7, 2021
Last Updated: May 17, 2017
Last Verified: May 2017