AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - 85
Updated:12/15/2018
Start Date:June 2008
End Date:August 2015

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Age-Related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study

The purpose of this study is to identify whether changes in age-related macular degeneration
(AMD) over time as seen with spectral domain optical coherence tomography (SDOCT) imaging,
can be used to predict vision loss and the advancement of AMD in people at moderate to high
risk for progression.

The primary objective of this study is to identify whether SDOCT patterns such as: drusen
size, OCT reflectivity within drusen, photoreceptor (PR)change over drusen, microfoci of
subretinal fluid (SRF), or retinal thickening are predictive of vision loss, progression of
drusen, progression of photoreceptor loss over drusen, development of choroidal
neovascularization (CNV), or development of geographic atrophy (GA).

The secondary objectives of this study are:

1. To define the relationship between SDOCT imaging, autofluorescence (AF)imaging, and
color photographic or other fundus imaging of AREDS 2 patients in both a cross-sectional
study of baseline data and a longitudinal study in data collected over the 5 year AREDS
2 study.

2. To compare the extent of geographic atrophy on SDOCT versus color photographs and
autofluorescence.

3. To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2
patients randomized to different oral supplements in the AREDS2.

Inclusion Criteria:

AMD subjects and controls

- Men and women between the ages of 50 and 85 years

AMD subjects

- Enrollment in the AREDS 2 trial;

- Macular status ranges from large drusen in both eyes or large drusen in one eye and
advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye

Exclusion Criteria:

- Ocular media not clear enough to allow good fundus photography.
We found this trial at
4
sites
Bethesda, Maryland 20892
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Bethesda, MD
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Atlanta, Georgia 30322
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Atlanta, GA
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Durham, North Carolina 27710
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Durham, NC
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Portland, Oregon 97210
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Portland, OR
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