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Completed

NCT Number: NCT00734487

AREDS 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.

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University Eye Center, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 2 years and 5 years

Secondary outcomes

  1. Drusen area measured from SDOCT versus from color fundus photographs. Mean change in drusen area reproducibility of measurements using these techniques.

    Time frame: 2 years and 5 years

  2. Grading of drusen type, presence or absence of fluid, photoreceptor loss or retinal thickening from SDOCT versus from color fundus photographs at each timepoint.

    Time frame: 2 years and 5 years

  3. Correlation between SDOCT imaging and autofluorescence imaging and onset of geographic atrophy.

    Time frame: 2 years and 5 years

  4. Measurement of area of GA from SDOCT images versus color fundus photos versus AF images.

    Time frame: 2 years and 5 years

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

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Acronym: A2ASDOCT

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Aug 14, 2008
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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