AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study (A2ASDOCT)

April 17, 2023 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

470

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Eye Center
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Eye Institute
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Eye Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Devers Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The A2A SDOCT study will recruit AMD subjects from the AREDS 2 study population at 4 AREDS 2 Study Centers. Controls will be recruited from Duke University Eye Center and Emory University.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1. AREDS2 subjects
Subjects enrolled in the AREDS2 clinical trial with a diagnosis of age-related macular degeneration.
2. Controls
Age-matched subjects without retinal pathology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 2 years and 5 years
2 years and 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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 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.
Time Frame: 2 years and 5 years
2 years and 5 years
Correlation between SDOCT imaging and autofluorescence imaging and onset of geographic atrophy.
Time Frame: 2 years and 5 years
2 years and 5 years
Measurement of area of GA from SDOCT images versus color fundus photos versus AF images.
Time Frame: 2 years and 5 years
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.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00001749
  • Genentech FVF4400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All findings resulting from the A2A SDOCT study will be prepared for publication in peer-reviewed journals and posted on PubMed Central once accepted.

We are supportive of efforts by publishers and professional societies to develop technologies for on-line publishing of entire experimental datasets. We will archive experimental results and findings from the proposed project for at least the duration of the project, and make the underlying datasets available to other researchers upon request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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