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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) )

Tracking Information
First Submitted Date December 8, 2017
First Posted Date December 11, 2017
Last Update Posted Date March 25, 2019
Actual Study Start Date May 23, 2018
Actual Primary Completion Date March 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2017)
The incidence of advanced AMD, cataract surgery and lung cancer will be the primary outcomes of the study. [ Time Frame: Study Completion ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03367767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 8, 2017)
Participant reports of incident cardiovascular events will be collected as secondary outcomes. [ Time Frame: Study Completion ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Age-Related Eye Disease Study 2 (AREDS2) 10-year Follow-On
Official Title Age-Related Eye Disease Study 2 (AREDS2) 10-Year Follow-On Study
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

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Former AREDS2 and AREDS2 Follow-On participants
Condition
  • AMD
  • Cancer
  • Cataract
Intervention Not Provided
Study Groups/Cohorts 1
Former AREDS2 and AREDS2 Follow-On participants
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 22, 2019)
709
Original Estimated Enrollment
 (submitted: December 8, 2017)
1000
Actual Study Completion Date March 21, 2019
Actual Primary Completion Date March 21, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03367767
Other Study ID Numbers 180023
18-EI-0023
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
Study Sponsor National Eye Institute (NEI)
Collaborators Not Provided
Investigators
Principal Investigator: Emily Y Chew, M.D. National Eye Institute (NEI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 2019