AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study (A2ASDOCT)
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.
Age Related Macular Degeneration
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Age-Related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Correlation between SDOCT imaging and autofluorescence imaging and onset of geographic atrophy. [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
- Measurement of area of GA from SDOCT images versus color fundus photos versus AF images. [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
1. AREDS2 subjects
Subjects enrolled in the AREDS2 clinical trial with a diagnosis of age-related macular degeneration.
Age-matched subjects without retinal pathology
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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||Devers Eye Institute|
|Principal Investigator:||Baker Hubbard, MD||Emory University Eye Center|
|Principal Investigator:||Wai T Wong, MD, PhD||National Eye Institute (NEI)|