Age-Related Eye Disease Study (AREDS) Follow-Up
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/5/2019 |
| Start Date: | January 3, 2008 |
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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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