Recruitment

Recruitment Status
Completed
Estimated Enrollment
62

Summary

Conditions
  • Age- Related Macular Degeneration
  • AMD
Type
Observational
Design
Time Perspective: Prospective

Participation Requirements

Age
Between 50 years and 85 years
Gender
Both males and females

Description

The Age Related Eye Disease Study 2 (AREDS2) was a multicenter Phase III randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 LCPUFAs as a treatment for age-related macular degeneration (AMD), ca...

The Age Related Eye Disease Study 2 (AREDS2) was a multicenter Phase III randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 LCPUFAs as a treatment for age-related macular degeneration (AMD), cataract and moderate vision loss. In addition to this objective, the study provided information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals included the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 also sought to validate the fundus photographic AMD scale developed from AREDS. Inclusion criteria in AREDS2 resulted in the enrollment of participants with intermediate AMD, defined by the presence of large drusen, with and without additional pigmentary changes. Owing to the longitudinal nature of AREDS2 study, anatomical features of AMD in study participants can be monitored and characterized as a function of time to further understand the steps in AMD progression. Spectral domain OCT (SDOCT) is a non-invasive imaging technology that has the speed and resolution to image fine structures such as drusen and the photoreceptor layers. With annotation and processing of three-dimensional SDOCT scans, focal AMD pathology such as drusen can be mapped and monitored over time. The AREDS2 Ancillary SDOCT Study (A2A SDOCT) added the use of novel higher resolution three-dimensional OCT retinal imaging at four AREDS2 study centers to examine 400 of the participants in the AREDS2 clinical trial. The purpose of this ancillary AREDS2 study (study acronym: A2A_SDOCT) is to identify whether measurable AMD pathology (drusen, photoreceptor layer thickness, early findings of geographic atrophy (GA) or neovascularization) imaged by spectral domain optical coherence tomography (SDOCT) can predict progression of AMD and vision loss. The A2A_SDOCT study began as an ancillary AREDS2 study; however AREDS2 had stopped gathering participant data on October 31, 2012 and will be terminated soon. This extension study is needed to complete the AREDS2 dataset by collecting images at one or two additional time points, as the study started over a year behind the AREDS2 study. The data collection period for the extension will end April 30, 2014. Data analysis will conclude by October 31, 2014. All AREDS2 study procedure guidelines for data collection will be followed, as described below, even though this visit falls outside the AREDS2 study timeline.

Locations

Bethesda, Maryland, 20892
Durham, North Carolina
Bethesda, Maryland, 20892
Durham, North Carolina

Tracking Information

NCT #
NCT01915238
Collaborators
Not Provided
Investigators
  • Principal Investigator: Wai T Wong, M.D. National Eye Institute (NEI)
  • Wai T Wong, M.D. National Eye Institute (NEI)