Trial record 2 of 8 for:    AREDS2

AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study (A2ASDOCT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734487
First received: August 13, 2008
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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
Age Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Age-Related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 470
Study Start Date: June 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
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)
  More Information

Additional Information:
No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734487     History of Changes
Other Study ID Numbers: Pro00001749, Genentech FVF4400
Study First Received: August 13, 2008
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014