NCT00734487

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

7.2 years

First QC Date

August 13, 2008

Last Update Submit

October 13, 2025

Conditions

Age Related Macular Degeneration

Keywords

Spectral Domain Optical Coherence TomographyOptical Coherence TomographyAREDS2AMDAge-related macular degenerationDrusen

Outcome Measures

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.

    2 years and 5 years

Secondary Outcomes (5)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Ocular media not clear enough to allow good fundus photography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Emory University Eye Center

Atlanta, Georgia, 30322, United States

Location

National Eye Institute

Bethesda, Maryland, 20892, United States

Location

Duke University Eye Center

Durham, North Carolina, 27705, United States

Location

Devers Eye Center

Portland, Oregon, 97210, United States

Location

Related Publications (12)

  • Folgar FA, Yuan EL, Sevilla MB, Chiu SJ, Farsiu S, Chew EY, Toth CA; Age Related Eye Disease Study 2 Ancillary Spectral-Domain Optical Coherence Tomography Study Group. Drusen Volume and Retinal Pigment Epithelium Abnormal Thinning Volume Predict 2-Year Progression of Age-Related Macular Degeneration. Ophthalmology. 2016 Jan;123(1):39-50.e1. doi: 10.1016/j.ophtha.2015.09.016. Epub 2015 Nov 12.

    PMID: 26578448BACKGROUND

  • Farsiu S, Chiu SJ, O'Connell RV, Folgar FA, Yuan E, Izatt JA, Toth CA; Age-Related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study Group. Quantitative classification of eyes with and without intermediate age-related macular degeneration using optical coherence tomography. Ophthalmology. 2014 Jan;121(1):162-172. doi: 10.1016/j.ophtha.2013.07.013. Epub 2013 Aug 29.

    PMID: 23993787BACKGROUND

  • Folgar FA, Chow JH, Farsiu S, Wong WT, Schuman SG, O'Connell RV, Winter KP, Chew EY, Hwang TS, Srivastava SK, Harrington MW, Clemons TE, Toth CA. Spatial correlation between hyperpigmentary changes on color fundus photography and hyperreflective foci on SDOCT in intermediate AMD. Invest Ophthalmol Vis Sci. 2012 Jul 9;53(8):4626-33. doi: 10.1167/iovs.12-9813.

    PMID: 22589439BACKGROUND

  • Chiu SJ, Izatt JA, O'Connell RV, Winter KP, Toth CA, Farsiu S. Validated automatic segmentation of AMD pathology including drusen and geographic atrophy in SD-OCT images. Invest Ophthalmol Vis Sci. 2012 Jan 5;53(1):53-61. doi: 10.1167/iovs.11-7640.

    PMID: 22039246BACKGROUND

  • Yiu G, Pecen P, Sarin N, Chiu SJ, Farsiu S, Mruthyunjaya P, Toth CA. Characterization of the choroid-scleral junction and suprachoroidal layer in healthy individuals on enhanced-depth imaging optical coherence tomography. JAMA Ophthalmol. 2014 Feb;132(2):174-81. doi: 10.1001/jamaophthalmol.2013.7288.

    PMID: 24336985BACKGROUND

  • Yiu G, Chiu SJ, Petrou PA, Stinnett S, Sarin N, Farsiu S, Chew EY, Wong WT, Toth CA. Relationship of central choroidal thickness with age-related macular degeneration status. Am J Ophthalmol. 2015 Apr;159(4):617-26. doi: 10.1016/j.ajo.2014.12.010. Epub 2014 Dec 17.

    PMID: 25526948BACKGROUND

  • Christenbury JG, Folgar FA, O'Connell RV, Chiu SJ, Farsiu S, Toth CA; Age-related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study Group. Progression of intermediate age-related macular degeneration with proliferation and inner retinal migration of hyperreflective foci. Ophthalmology. 2013 May;120(5):1038-45. doi: 10.1016/j.ophtha.2012.10.018. Epub 2013 Jan 23.

    PMID: 23352193BACKGROUND

  • Leuschen JN, Schuman SG, Winter KP, McCall MN, Wong WT, Chew EY, Hwang T, Srivastava S, Sarin N, Clemons T, Harrington M, Toth CA. Spectral-domain optical coherence tomography characteristics of intermediate age-related macular degeneration. Ophthalmology. 2013 Jan;120(1):140-50. doi: 10.1016/j.ophtha.2012.07.004. Epub 2012 Sep 8.

    PMID: 22968145BACKGROUND

  • Chiu SJ, Li XT, Nicholas P, Toth CA, Izatt JA, Farsiu S. Automatic segmentation of seven retinal layers in SDOCT images congruent with expert manual segmentation. Opt Express. 2010 Aug 30;18(18):19413-28. doi: 10.1364/OE.18.019413.

    PMID: 20940837BACKGROUND

  • Jain N, Farsiu S, Khanifar AA, Bearelly S, Smith RT, Izatt JA, Toth CA. Quantitative comparison of drusen segmented on SD-OCT versus drusen delineated on color fundus photographs. Invest Ophthalmol Vis Sci. 2010 Oct;51(10):4875-83. doi: 10.1167/iovs.09-4962. Epub 2010 Apr 14.

    PMID: 20393117BACKGROUND

  • Veerappan M, El-Hage-Sleiman AM, Tai V, Chiu SJ, Winter KP, Stinnett SS, Hwang TS, Hubbard GB 3rd, Michelson M, Gunther R, Wong WT, Chew EY, Toth CA; Age-related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study Group. Optical Coherence Tomography Reflective Drusen Substructures Predict Progression to Geographic Atrophy in Age-related Macular Degeneration. Ophthalmology. 2016 Dec;123(12):2554-2570. doi: 10.1016/j.ophtha.2016.08.047. Epub 2016 Oct 25.

    PMID: 27793356BACKGROUND

  • Sleiman K, Veerappan M, Winter KP, McCall MN, Yiu G, Farsiu S, Chew EY, Clemons T, Toth CA; Age-Related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study Group. Optical Coherence Tomography Predictors of Risk for Progression to Non-Neovascular Atrophic Age-Related Macular Degeneration. Ophthalmology. 2017 Dec;124(12):1764-1777. doi: 10.1016/j.ophtha.2017.06.032. Epub 2017 Aug 26.

    PMID: 28847641BACKGROUND

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Cynthia A Toth, MD

    Duke Health

    STUDY CHAIR

  • Thomas Hwang, MD

    Devers Eye Institute

    PRINCIPAL INVESTIGATOR

  • Baker Hubbard, MD

    Emory University Eye Center

    PRINCIPAL INVESTIGATOR

  • Wai T Wong, MD, PhD

    National Eye Institute (NEI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Locations

US(4)