Cancer Clinical Trial
Official title:
Age-Related Eye Disease Study 2 (AREDS2) 10-Year Follow-On Study
Verified date | March 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 709 |
Est. completion date | March 21, 2019 |
Est. primary completion date | March 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of advanced AMD, cataract surgery and lung cancer will be the primary outcomes of the study. | Study Completion | ||
Secondary | Participant reports of incident cardiovascular events will be collected as secondary outcomes. | Study Completion |
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