AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study
NCT ID: NCT00734487
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
470 participants
OBSERVATIONAL
2008-06-30
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1. AREDS2 subjects
Subjects enrolled in the AREDS2 clinical trial with a diagnosis of age-related macular degeneration.
No interventions assigned to this group
2. Controls
Age-matched subjects without retinal pathology
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
85 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Duke University
OTHER
Responsible Party
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Principal Investigators
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Cynthia A Toth, MD
Role: STUDY_CHAIR
Duke Health
Thomas Hwang, MD
Role: PRINCIPAL_INVESTIGATOR
Devers Eye Institute
Baker Hubbard, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Eye Center
Wai T Wong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Eye Institute (NEI)
Locations
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Emory University Eye Center
Atlanta, Georgia, United States
National Eye Institute
Bethesda, Maryland, United States
Duke University Eye Center
Durham, North Carolina, United States
Devers Eye Center
Portland, Oregon, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Age-Related Eye Disease Study 2
Age-Related Eye Disease Study 2 (AREDS2) registry at ClinicalTrials.gov
Other Identifiers
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Genentech FVF4400
Identifier Type: -
Identifier Source: secondary_id
Pro00001749
Identifier Type: -
Identifier Source: org_study_id
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