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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition
Age-Related Macular Degeneration
Cataract

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Age-Related Eye Disease Study (AREDS) and AREDS2 Follow-Up

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 160
Study Start Date: January 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594672

Contacts
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

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Emily Y Chew, M.D. National Eye Institute (NEI)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00594672     History of Changes
Other Study ID Numbers: 080043, 08-EI-0043
Study First Received: January 4, 2008
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Age-Related Macular Degeneration (AMD)
Cataracts
Age Related Macular Degeneration
AMD
Cataract

Additional relevant MeSH terms:
Macular Degeneration
Cataract
Eye Diseases
Retinal Degeneration
Retinal Diseases
Lens Diseases

ClinicalTrials.gov processed this record on September 18, 2014