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Age-Related Eye Disease Study 2 (AREDS2) 10-year Follow-On

Sponsor
National Eye Institute (NEI) (NIH)
Overall Status
Completed
CT.gov ID
NCT03367767
Collaborator
(none)
709
Enrollment
1
Location
9.9
Actual Duration (Months)
71.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Age-related macular degeneration (AMD) and cataracts are two eye diseases. They were studied in the Age-Related Eye Disease Study (AREDS2) and the AREDS2 Follow-On study. These studies followed the natural course of the diseases. They also provided data on the long-term effects of certain oral supplements on AMD.

Objective:

To study the long-term effects of oral supplements on several things. These include incidences of lung cancer, development of late AMD, cataract surgery, cognitive function, and cardiovascular events.

Eligibility:

Former AREDS2 and AREDS2 Follow-On participants

Design:
Participants will have 1 visit. It will include:

An eye exam that tests how well participants can see, measures eye pressure, and checks eye movements. The pupil will be dilated with eye drops. Pictures will be taken of the retina and the inside of the eye.

Participants will grip a device in their hand to measure their grip strength.

A blood sample will be taken. This will be stored for future genetic research. Cells may be created from the sample.

A small sample of skin will be taken.

Sponsoring Institution: National Eye Institute

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Objective: The overall objective of this extended follow-up study is to provide data regarding the incidence of late age-related macular degeneration (AMD), cataract surgery and lung cancer in the approximately 1,200 AREDS2 study participants enrolled in the Follow-on study. The specific objectives for the study are to:

    • Study the rates of progression to late AMD, neovascular AMD, or geographic atrophy associated with AMD.

    • To seek incidences of lung cancer, by treatment assignment.

    • To assess cognitive understanding by phone prior to coming into the clinic.

    • To seek incidences of cardiovascular events.

    Study Population: Up to 3,200 participants who were previously enrolled in the AREDS2 and AREDS2 Follow-on protocols are currently followed by telephone contact every six months for the past four years. It is expected that 1,200 of these 3,200 participants will be eligible to participate in the study. Up to 83 participants will be enrolled at the NEI.

    Design: This is an extension of the multicenter, randomized trial of lutein, zeaxanthin and omega-3 polyunsaturated fatty acids in the AMD AREDS2 trial. Data for this extension will be collected by staff at selected AREDS2 clinical sites via an in-clinic visit.

    Outcome Measures: The primary outcomes of the study will be the rates of progression to late AMD, neovascular AMD or geographic atrophy associated with AMD. Also of interest are the long-term rates of progression to late AMD, incidents of lung cancer and cataract surgery. Participant reports of incident cardiovascular events will be collected as secondary outcomes.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    709 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Age-Related Eye Disease Study 2 (AREDS2) 10-Year Follow-On Study
    Actual Study Start Date :
    May 23, 2018
    Actual Primary Completion Date :
    Mar 21, 2019
    Actual Study Completion Date :
    Mar 21, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Former AREDS2 and AREDS2 Follow-On participants

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of advanced AMD, cataract surgery and lung cancer will be the primary outcomes of the study. [Study Completion]

    Secondary Outcome Measures

    1. Participant reports of incident cardiovascular events will be collected as secondary outcomes. [Study Completion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:

    To participate in this study, the potential participant must meet all of the following criteria:

    1. Previously enrolled in the AREDS2 and AREDS2 Follow-on protocols.

    2. Participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form s contents and provide written informed consent.

    EXCLUSION CRITERIA:

    There are no Exclusion Criteria.

    Contacts and Locations

    Locations

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

    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

    Publications

    None provided.
    Responsible Party:
    National Eye Institute (NEI)
    ClinicalTrials.gov Identifier:
    NCT03367767
    Other Study ID Numbers:
    • 180023
    • 18-EI-0023
    First Posted:
    Dec 11, 2017
    Last Update Posted:
    Mar 25, 2019
    Last Verified:
    Mar 1, 2019
    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)
    Blood Sample
    Medical History
    Optical Imaging
    Additional relevant MeSH terms:
    Cataract
    Eye Diseases

    Study Results

    No Results Posted as of Mar 25, 2019