Age-Related Eye Disease Study (AREDS) Follow-Up

This study is a 5-year extension of the AREDS protocol, in which investigators followed the natural course of age-related macular degeneration (AMD) and cataracts. Participants in the former AREDS protocol are eligible for this study.

Participants have a complete eye examination once a year and are contacted at least once a year between visits to check on their status. The eye examination includes measurement of visual acuity (vision chart test) and examination of the inside of the eye after the pupils have been dilated with eye drops. Photographs of the inside of the eye may be taken using a special camera that flashes a bright light in the eye. A blood sample may be obtained to test for cholesterol level and genes related to inflammation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age-Related Macular Degeneration Cataract Eye Diseases Lens Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

The Age-Related Eye Disease Study (AREDS) Follow-Up protocol allows us to continue with the follow-up of participants who were enrolled in the clinical trial of antioxidant vitamins and zinc. The AREDS study was designed in the beginning to determine the clinical course and prognosis of age-related macular degeneration (AMD) and cataracts.1 In addition, AREDS evaluated the possible risk factors associated with the development of AMD and cataracts; the nutritional risk factors were evaluated and published in October 2001.

Study results showed that antioxidant vitamins and zinc therapy reduced the risk of developing advanced AMD in participants with intermediate and greater risk of developing AMD (categories 3 and 4) by 25%. The risk of vision loss of three lines or more on the logarithmic visual acuity charts was also reduced by 19% for these participants. For those who developed AMD, their risk of vision loss was reduced by 25%. Antioxidants and zinc are now recommended for participants who have an intermediate risk of developing advanced AMD.

Upon completion of the AREDS clinical trial in September 2001, participants were invited for follow-up for an additional five years to collect further data on the natural course of both AMD and cataracts. Although the multi-center trial was complete in December 2005, we wish to continue to follow-up on these participants at the NEI on an annual basis for a minimum of five years from the date of enrollment in this study to collect additional data.

Although results from AREDS on the relationship of lutein/zeaxanthin and omega-3 long-chain polyunsaturated fatty acid (LCPUFA) intake with advanced AMD were informative, the non-experimental sampling (observational) design limited our strength of inference. AREDS2, a multi-center Phase III randomized clinical trial, was designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 LCPUFAs as a treatment for AMD, cataract, and moderate vision loss. In addition to this objective, the study provided information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals included the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 also sought to validate the fundus photographic AMD scale developed from AREDS. Participants who completed AREDS2 are invited for follow-up on an annual basis for at least five years from the date of enrollment in this study to collect additional data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA:

Participants will be eligible if they:

Were enrolled in the AREDS or AREDS2 protocol and successfully completed the final AREDS or AREDS2 follow-up visit.
Can understand and provide informed consent.

Exclusion criteria

Participants will not be eligible if they:

Are under the age of 50.
Are not able to return to NIH for examination for the duration of the trial.
Have any systemic diseases that compromise the ability to provide adequate ophthalmologic examination.

Treatment and study plan

Primary outcomes

Outcomes assessed will be based on the ongoing ocular examination and historical data that will be obtained at each visit. The visual acuity data and the photographic documentation of the two diseases will be of particular importance.

Time frame: 5 years

Data on possible ocular events for both AMD and cataracts and for documentation of any adverse effects associated with the AREDS treatment.

Sponsors and collaborators

Lead sponsor

National Eye Institute (NEI)

Nih

Registry information

Official study title

Age-Related Eye Disease Study (AREDS) and AREDS2 Follow-Up

Important dates

Study start: 2008
First posted: Jan 16, 2008
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting