Age-Related Eye Disease Study (AREDS) Follow-Up

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Active, not recruiting
CT.gov ID
NCT00594672
Collaborator
(none)
110
Enrollment
1
Location

Study Details

Study Description

Brief Summary

This study is a 5-year extension of the AREDS protocol, in which investigators followed the natural course of age-related macular degeneration (AMD) and cataracts. Participants in the former AREDS protocol are eligible for this study.

Participants have a complete eye examination once a year and are contacted at least once a year between visits to check on their status. The eye examination includes measurement of visual acuity (vision chart test) and examination of the inside of the eye after the pupils have been dilated with eye drops. Photographs of the inside of the eye may be taken using a special camera that flashes a bright light in the eye. A blood sample may be obtained to test for cholesterol level and genes related to inflammation.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    The Age-Related Eye Disease Study (AREDS) Follow-Up protocol allows us to continue with the follow-up of participants who were enrolled in the clinical trial of antioxidant vitamins and zinc. The AREDS study was designed in the beginning to determine the clinical course and prognosis of age-related macular degeneration (AMD) and cataracts.1 In addition, AREDS evaluated the possible risk factors associated with the development of AMD and cataracts; the nutritional risk factors were evaluated and published in October 2001.

    Study results showed that antioxidant vitamins and zinc therapy reduced the risk of developing advanced AMD in participants with intermediate and greater risk of developing AMD (categories 3 and 4) by 25%. The risk of vision loss of three lines or more on the logarithmic visual acuity charts was also reduced by 19% for these participants. For those who developed AMD, their risk of vision loss was reduced by 25%. Antioxidants and zinc are now recommended for participants who have an intermediate risk of developing advanced AMD.

    Upon completion of the AREDS clinical trial in September 2001, participants were invited for follow-up for an additional five years to collect further data on the natural course of both AMD and cataracts. Although the multi-center trial was complete in December 2005, we wish to continue to follow-up on these participants at the NEI on an annual basis for a minimum of five years from the date of enrollment in this study to collect additional data.

    Although results from AREDS on the relationship of lutein/zeaxanthin and omega-3 long-chain polyunsaturated fatty acid (LCPUFA) intake with advanced AMD were informative, the non-experimental sampling (observational) design limited our strength of inference. AREDS2, a multi-center Phase III randomized clinical trial, was 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 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. Participants who completed AREDS2 are invited for follow-up on an annual basis for at least five years from the date of enrollment in this study to collect additional data.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Age-Related Eye Disease Study (AREDS) and AREDS2 Follow-Up
    Actual Study Start Date :
    Jun 2, 2008

    Arms and Interventions

    ArmIntervention/Treatment
    AREDS participants

    Participants who were enrolled in the AREDS or AREDS2 protocol and successfully completed the final AREDS or AREDS2 follow-up visit.

    Outcome Measures

    Primary Outcome Measures

    1. Outcomes assessed will be based on the ongoing ocular examination and historical data that will be obtained at each visit. The visual acuity data and the photographic documentation of the two diseases will be of particular importance. [5 years]

      Data on possible ocular events for both AMD and cataracts and for document of any adverse effects associated with the AREDS treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:
    Participants will be eligible if they:
    • Were enrolled in the AREDS or AREDS2 protocol and successfully completed the final AREDS or AREDS2 follow-up visit.

    • Can understand and provide informed consent.

    EXCLUSION CRITERIA:
    Participants will not be eligible if they:
    • Are under the age of 50.

    • Are not able to return to NIH for examination for the duration of the trial.

    • Have any systemic diseases that compromise the ability to provide adequate ophthalmologic examination.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: Emily Y Chew, M.D., National Eye Institute (NEI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Eye Institute (NEI)
    ClinicalTrials.gov Identifier:
    NCT00594672
    Other Study ID Numbers:
    • 080043
    • 08-EI-0043
    First Posted:
    Jan 16, 2008
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Sep 14, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Eye Institute (NEI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021