AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study (A2ASDOCT)
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|ClinicalTrials.gov Identifier: NCT00734487|
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : October 1, 2019
|Condition or disease|
|Age Related Macular Degeneration|
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.
|Study Type :||Observational|
|Actual Enrollment :||470 participants|
|Official Title:||Age-Related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
1. AREDS2 subjects
Subjects enrolled in the AREDS2 clinical trial with a diagnosis of age-related macular degeneration.
Age-matched subjects without retinal pathology
- 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 ]
- 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 ]
- 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 ]
- Correlation between SDOCT imaging and autofluorescence imaging and onset of geographic atrophy. [ Time Frame: 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734487
|United States, Georgia|
|Emory University Eye Center|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|National Eye Institute|
|Bethesda, Maryland, United States, 20892|
|United States, North Carolina|
|Duke University Eye Center|
|Durham, North Carolina, United States, 27705|
|United States, Oregon|
|Devers Eye Center|
|Portland, Oregon, United States, 97210|
|Study Chair:||Cynthia A Toth, MD||Duke University Health System|
|Principal Investigator:||Thomas Hwang, MD||Legacy Devers Eye Institute|
|Principal Investigator:||Baker Hubbard, MD||Emory University Eye Center|
|Principal Investigator:||Wai T Wong, MD, PhD||National Eye Institute (NEI)|