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Blood and Saliva Sample Collection for AREDS 2

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Completed
CT.gov ID
NCT01553474
Collaborator
(none)
56
Enrollment
1
Location
11.4
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    56 participants
    Time Perspective:
    Prospective
    Official Title:
    Blood and Saliva Sample Collection and Submission to the Age-Related Eye Disease Study 2 (AREDS2) Genetic Repository
    Study Start Date :
    Feb 24, 2012
    Study Completion Date :
    Feb 5, 2013

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      55 Years to 85 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      • 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

      Locations

      Site City State Country Postal Code
      1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Eye Institute (NEI)

      Investigators

      • Principal Investigator: Wai T Wong, M.D., National Eye Institute (NEI)

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01553474
      Other Study ID Numbers:
      • 120085
      • 12-EI-0085
      First Posted:
      Mar 14, 2012
      Last Update Posted:
      Jul 29, 2019
      Last Verified:
      Feb 5, 2013
      Keywords provided by , ,
      Age-Related Macular Degeneration (AMD)
      Eye Diseases
      Additional relevant MeSH terms:
      Macular Degeneration
      Eye Diseases

      Study Results

      No Results Posted as of Jul 29, 2019