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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: October 9, 2014
Last verified: February 2013
  Purpose

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.

Condition
Age-Related Macular Degeneration
Eye Diseases

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Blood and Saliva Sample Collection and Submission to the Age-Related Eye Disease Study 2 (AREDS2) Genetic Repository

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 56
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
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.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  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: NCT01553474

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Wai T Wong, M.D. National Eye Institute (NEI)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01553474     History of Changes
Other Study ID Numbers: 120085, 12-EI-0085
Study First Received: March 13, 2012
Last Updated: October 9, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Age-Related Macular Degeneration (AMD)
Eye Diseases

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

ClinicalTrials.gov processed this record on November 27, 2014