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

This study is currently recruiting participants.
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00594672
First received: January 4, 2008
Last updated: March 14, 2014
Last verified: December 2013

January 4, 2008
March 14, 2014
January 2008
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Outcome assessment will be based on the ongoing ocular examination and historical data that will be obtained at each visit. Of particular importance will be the visual acuity data and the photographic documentation.
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Complete list of historical versions of study NCT00594672 on ClinicalTrials.gov Archive Site
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Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Eye Disease Study (AREDS) and AREDS2 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.

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. AREDS study was designed in the beginning to determine the clinical course and prognosis of age-related macular degeneration (AMD) and cataracts. 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 these participants 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 will provide information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals include the evaluation of eliminating beta-carotene and/or reducing zinc in the original AREDS formulation on the progression and development of AMD. AREDS2 will also seek to validate the fundus photographic AMD scale developed from AREDS. Upon completion of AREDS2, participants will be 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.

Observational
Time Perspective: Prospective
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  • Age-Related Macular Degeneration
  • Cataract
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
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  • 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.
Both
50 Years and older
No
Contact: Katherine H Shimel, R.N. (301) 402-2863 shimelk@nei.nih.gov
Contact: Emily Y Chew, M.D. (301) 496-6583 chewe@mail.nih.gov
United States
 
NCT00594672
080043, 08-EI-0043
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National Eye Institute (NEI)
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Principal Investigator: Emily Y Chew, M.D. National Eye Institute (NEI)
National Institutes of Health Clinical Center (CC)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP