Blood and Saliva Sample Collection for AREDS 2

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01553474
First received: March 13, 2012
Last updated: January 14, 2014
Last verified: February 2013

March 13, 2012
January 14, 2014
February 2012
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Complete list of historical versions of study NCT01553474 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Time Perspective: Prospective
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  • Age-Related Macular Degeneration
  • Eye Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
February 2013
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  • INCLUSION CRITERIA:

Participants will be eligible if they were enrolled in the AREDS2 protocol and willing to have their blood drawn and saliva collected.

EXCLUSION CRITERIA:

Participants will not be eligible if they were not enrolled in AREDS2 and are not willing to have their blood drawn and saliva collected.

Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01553474
120085, 12-EI-0085
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National Eye Institute (NEI)
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Principal Investigator: Wai T Wong, M.D. National Eye Institute (NEI)
National Institutes of Health Clinical Center (CC)
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP