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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 : May 17, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Age Related Macular Degeneration

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.

Study Type : Observational
Actual Enrollment : 470 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  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. [ Time Frame: 2 years and 5 years ]

Secondary Outcome Measures :
  1. 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 ]
  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. [ Time Frame: 2 years and 5 years ]
  3. Correlation between SDOCT imaging and autofluorescence imaging and onset of geographic atrophy. [ Time Frame: 2 years and 5 years ]
  4. Measurement of area of GA from SDOCT images versus color fundus photos versus AF images. [ Time Frame: 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. [ Time Frame: 5 years ]


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Duke University
Genentech, Inc.
Investigators
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)

Additional Information:
Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734487     History of Changes
Other Study ID Numbers: Pro00001749
Genentech FVF4400
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.


Keywords provided by Duke University:
Spectral Domain Optical Coherence Tomography
Optical Coherence Tomography
AREDS2
AMD
Age-related macular degeneration
Drusen

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases