NCT00594672

Brief Summary

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.

Trial Health

73
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

June 2, 2008

Completed
Last Updated

May 1, 2026

Status Verified

April 23, 2026

First QC Date

January 4, 2008

Last Update Submit

April 30, 2026

Conditions

CataractAge-Related Macular Degeneration

Keywords

CataractAge-Related Macular DegenerationAge-Related Macular Degeneration (AMD)CataractsNatural HistoryAge Related Macular DegenerationAMD

Outcome Measures

Primary Outcomes (1)

  • 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.

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

    5 years

Study Arms (1)

AREDS participants

Participants who were enrolled in the AREDS or AREDS2 protocol and successfully completed the final AREDS or AREDS2 follow-up visit.

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who were enrolled in the AREDS or AREDS2 protocol and successfully completed the final AREDS or AREDS2 follow-up visit.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (5)

  • Seddon JM, De D, Rosner B. The role of nutritional factors in transitioning between early, mid, and late stages of age-related macular degeneration: prospective longitudinal analysis. Am J Clin Nutr. 2024 Dec;120(6):1387-1398. doi: 10.1016/j.ajcnut.2024.08.019. Epub 2024 Aug 23.

    PMID: 39181206DERIVED

  • Seddon JM, Silver RE, Rosner B. Response to AREDS supplements according to genetic factors: survival analysis approach using the eye as the unit of analysis. Br J Ophthalmol. 2016 Dec;100(12):1731-1737. doi: 10.1136/bjophthalmol-2016-308624. Epub 2016 Jul 28.

    PMID: 27471039DERIVED

  • Merle BM, Silver RE, Rosner B, Seddon JM. Dietary folate, B vitamins, genetic susceptibility and progression to advanced nonexudative age-related macular degeneration with geographic atrophy: a prospective cohort study. Am J Clin Nutr. 2016 Apr;103(4):1135-44. doi: 10.3945/ajcn.115.117606.

    PMID: 26961928DERIVED

  • Merle BM, Silver RE, Rosner B, Seddon JM. Adherence to a Mediterranean diet, genetic susceptibility, and progression to advanced macular degeneration: a prospective cohort study. Am J Clin Nutr. 2015 Nov;102(5):1196-206. doi: 10.3945/ajcn.115.111047. Epub 2015 Oct 21.

    PMID: 26490493DERIVED

  • Sangiovanni JP, Agron E, Meleth AD, Reed GF, Sperduto RD, Clemons TE, Chew EY; Age-Related Eye Disease Study Research Group. omega-3 Long-chain polyunsaturated fatty acid intake and 12-y incidence of neovascular age-related macular degeneration and central geographic atrophy: AREDS report 30, a prospective cohort study from the Age-Related Eye Disease Study. Am J Clin Nutr. 2009 Dec;90(6):1601-7. doi: 10.3945/ajcn.2009.27594. Epub 2009 Oct 7.

    PMID: 19812176DERIVED

Related Links

MeSH Terms

Conditions

Macular DegenerationCataract

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesLens Diseases

Study Officials

  • Emily Y Chew, M.D.

    National Eye Institute (NEI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

June 2, 2008

Last Updated

May 1, 2026

Record last verified: 2026-04-23

Data Sharing

IPD Sharing
Will not share

Locations

US(1)