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

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ClinicalTrials.gov Identifier: NCT03367767
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Study Description
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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
AMD Cancer Cataract

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
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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 : March 21, 2019
Actual Study Completion Date : March 21, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
Former AREDS2 and AREDS2 Follow-On participants


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of advanced AMD, cataract surgery and lung cancer will be the primary outcomes of the study. [ Time Frame: Study Completion ]

Secondary Outcome Measures :
  1. Participant reports of incident cardiovascular events will be collected as secondary outcomes. [ Time Frame: Study Completion ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Former AREDS2 and AREDS2 Follow-On participants
Criteria
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367767


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
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Principal Investigator: Emily Y Chew, M.D. National Eye Institute (NEI)
More Information
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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT03367767    
Other Study ID Numbers: 180023
18-EI-0023
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Blood Sample
Medical History
Optical Imaging
Additional relevant MeSH terms:
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Cataract
Eye Diseases
Lens Diseases