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 participants 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.
Study Type
OBSERVATIONAL
Enrollment
296
No intervention was administered in this study.
Northwest Arkansas Retina Associates
Springdale, Arkansas, United States
Retinal Diagnostic Center
Campbell, California, United States
Specialty Eye Care Medical Center
Glendale, California, United States
Jules Stein Eye Institute/ UCLA
Los Angeles, California, United States
East Bay Retina Consultants
Oakland, California, United States
Number of Scotomatous Points as Assessed by Mesopic Microperimetry (MP)
Time frame: Baseline up to end of study (up to approximately 48 months)
Macular Sensitivity as Assessed by Mesopic MP
Time frame: Baseline up to end of study (up to approximately 48 months)
Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Time frame: Baseline up to end of study (up to approximately 48 months)
BCVA Score as Assessed by ETDRS Chart Under Low Luminance Conditions
Time frame: Baseline up to end of study (up to approximately 48 months)
Monocular and Binocular Reading Speed as Assessed by the Minnesota Low-Vision Reading Test (MNRead) or by Radner Reading Cards
Time frame: Baseline up to end of study (up to approximately 48 months)
Monocular and Binocular Critical Print Size as Assessed by the MNRead or by Radner Reading Cards
Time frame: Baseline up to end of study (up to approximately 48 months)
Change from Baseline in the GA area, as Assessed by Fundus Autofluorescence (FAF)
Time frame: Baseline, end of study (up to approximately 48 months)
Change from Baseline in National Eye Institute Visual Functioning Questionnaire 25-item Version (NEI VFQ-25) Score
Time frame: Baseline, end of study (up to approximately 48 months)
Change from Baseline in Functional Reading Independence (FRI) Index Score
Time frame: Baseline, end of study (up to approximately 48 months)
Percentage of Participants With Medical Events of Interest (MEIs)
The clinical events (cardiovascular, respiratory, cognitive, ocular events etc.) occurring during the study are termed as MEIs. These events will be collected using MEI electronic Case Report Form (eCRF) checklist.
Time frame: Baseline up to end of study (up to approximately 48 months)
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Colorado Retina Associates, PC
Golden, Colorado, United States
Rand Eye
Deerfield Beach, Florida, United States
Bascom Palmer Eye Institute
Naples, Florida, United States
Center For Sight
Sarasota, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
...and 81 more locations