Clinical trial NCT03367767: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AMD
Cancer
Cataract
Keywords: Blood Sample
Medical History
Optical Imaging
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-12-11
Enrollment: 709
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Former AREDS2 and AREDS2 Follow-On participants

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.

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.

Primary outcomes:
measure: The incidence of advanced AMD, cataract surgery and lung cancer will be the primary outcomes of the study.
timeFrame: Study Completion
Secondary outcomes:
measure: Participant reports of incident cardiovascular events will be collected as secondary outcomes.
timeFrame: Study Completion
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Eye Institute (NEI)
name: Emily Y Chew, M.D.
role: PRINCIPAL_INVESTIGATOR
References: