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Age Related Macular DegenerationA2ASDOCTNCT00734487

AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study

An observational study of Age Related Macular Degeneration, run by Duke University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Age Related Macular Degeneration
How many people
470 participants
Where
4 sitesUnited States
Study dates
Jun 2008to Aug 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Emory University Eye Center

    Atlanta, Georgia, 30322

  • National Eye Institute

    Bethesda, Maryland, 20892

  • Duke University Eye Center

    Durham, North Carolina, 27705

  • Devers Eye Center

    Portland, Oregon, 97210

Other trials in United States

About this study

Official title: 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.

Read the 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.
Keywords
Spectral Domain Optical Coherence Tomography, Optical Coherence Tomography, AREDS2, AMD, Age-related macular degeneration, Drusen
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00734487
Study groupRoleWhat they receive
1. AREDS2 subjectsSubjects enrolled in the AREDS2 clinical trial with a diagnosis of age-related macular degeneration.
2. ControlsAge-matched subjects without retinal pathology

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years and 5 years

Secondary outcomes (5)
  1. Drusen area measured from SDOCT versus from color fundus photographs. Mean change in drusen area reproducibility of measurements using these techniques.

    Measured: 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.

    Measured: 2 years and 5 years

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

    Measured: 2 years and 5 years

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

    Measured: 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00734487
Sponsor's protocol ID
Pro00001749
Other IDs
Genentech FVF4400
Acronym
A2ASDOCT
Status last verified
Oct 2025
First submitted
13 Aug 2008
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 26578448
  • 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.

    PubMed 23993787
  • 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.

    PubMed 22589439
  • 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.

    PubMed 22039246
  • 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.

    PubMed 24336985
  • 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.

    PubMed 25526948
  • 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.

    PubMed 23352193
  • 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.

    PubMed 22968145
  • 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.

    PubMed 20940837
  • 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.

    PubMed 20393117
  • 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.

    PubMed 27793356
  • 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.

    PubMed 28847641

Questions about this trial

What is this clinical trial studying?

An observational study of Age Related Macular Degeneration, run by Duke University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00734487, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.

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