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

ID: NCT03367767
Status: Recruiting
Phase: N/A
Start Date: March 01, 2018
First Submitted: December 08, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: National Eye Institute (NEI)
Location: United States
Conditions: AMD, Cancer, Cataract
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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

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.
Condition or disease Intervention/treatment Phase

AMD

Cancer

Cataract

N/A

Tracking Information

First Submitted DateDecember 08, 2017
Last Update Posted DateFebruary 23, 2018
Anticipated Start DateMarch 01, 2018
Anticipated Completion DateDecember 31, 2019
Anticipated Primary Completion DateAugust 31, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • 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

Not Available

Current Secondary Outcome Measures

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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleAge-Related Eye Disease Study 2 (AREDS2) 10-year Follow-On
Official TitleAge-Related Eye Disease Study 2 (AREDS2) 10-Year Follow-On
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 TypeObservational
Study PhaseN/A
Estimated Enrollment
1000
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
AMD
Cancer
Cataract
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationFormer AREDS2 and AREDS2 Follow-On participants
Intervention
Not Available
Study Groups/Cohorts
1
Former AREDS2 and AREDS2 Follow-On participants

Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Recruiting
Enrollment1000
Completion DateDecember 31, 2019
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.
GenderAll
Age50 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03367767
Other Study ID Numbers
180023
18-EI-0023
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
National Eye Institute (NEI)
Collaborators
Not Available
Investigators
Principal Investigator
Emily Y Chew, M.D.
National Eye Institute (NEI)