AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. To compare the extent of geographic atrophy on SDOCT versus color photographs and autofluorescence. To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2 patients randomized to different oral supplements in the AREDS2.

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

Conditions
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Age Related Macular Degeneration

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1. AREDS2 subjects<br>Subjects enrolled in the AREDS2 clinical trial with a diagnosis of age-related macular degeneration. | |
| 2. Controls<br>Age-matched subjects without retinal pathology | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome measures are the percent of eyes developing CNV, mean change in visual acuity, and change in drusen volume, area of GA and photoreceptor layer thickness from SDOCT centered on the fovea. |  | 2 years and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drusen area measured from SDOCT versus from color fundus photographs. Mean change in drusen area reproducibility of measurements using these techniques. |  | 2 years and 5 years | 
| Grading of drusen type, presence or absence of fluid, photoreceptor loss or retinal thickening from SDOCT versus from color fundus photographs at each timepoint. |  | 2 years and 5 years | 
| Correlation between SDOCT imaging and autofluorescence imaging and onset of geographic atrophy. |  | 2 years and 5 years | 
| Measurement of area of GA from SDOCT images versus color fundus photos versus AF images. |  | 2 years and 5 years | 
| To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2 patients randomized to different oral supplements in the AREDS2. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spectral Domain Optical Coherence Tomography, Optical Coherence Tomography, AREDS2, AMD, Age-related macular degeneration, Drusen