Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
Study NCT ID:
NCT03367767
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2017-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Age-Related Eye Disease Study 2 (AREDS2) 10-year Follow-On
Sponsor:
National Eye Institute (NEI)
Organization:
Study Overview
Official Title:
Age-Related Eye Disease Study 2 (AREDS2) 10-Year Follow-On Study
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18-EI-0023 | None | None | View |