Clinical Trials Directory

Trials / Completed

CompletedNCT01553474

Blood and Saliva Sample Collection for AREDS 2

Blood and Saliva Sample Collection and Submission to the Age-Related Eye Disease Study 2 (AREDS2) Genetic Repository

Status
Completed
Phase
Study type
Observational
Enrollment
56 (actual)
Sponsor
National Eye Institute (NEI) · NIH
Sex
All
Age
55 Years – 85 Years
Healthy volunteers
Not accepted

Summary

Background: \- The Age-Related Eye Disease Study 2 (AREDS 2) is looking at different eye diseases. Study participants will provide blood and saliva samples. The samples will be stored for research on eye diseases. Objectives: \- To collect blood and saliva samples for AREDS 2 research. Eligibility: \- AREDS 2 research study participants. Design: * Participants will provide blood and saliva samples. * The samples will be submitted with personal and medical information. This information will be collected during the AREDS 2 procedures.

Detailed description

AREDS2 is a multi-center, 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 long-chain polyunsaturated fatty acids (LCPUFAs) as a treatment for age-related macular degeneration (AMD), cataract and moderate vision loss. In addition to this objective, the AREDS2 study will provide information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals include the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 will also seek to validate the fundus photographic AMD scale developed from AREDS. The objective of this protocol is to have AREDS2 participants submit blood and saliva samples to the AREDS2 Genetic Repository (Fisher BioServices, Rockville, MD) in order to provide further materials for the study of the genetic and biochemical bases for eye disease and possibly other diseases.

Conditions

Timeline

Start date
2012-02-24
Completion
2013-02-05
First posted
2012-03-14
Last updated
2019-07-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01553474. Inclusion in this directory is not an endorsement.