Suspended

Antioxidant Vitamins and Zinc Therapy for Intermediate Risk of Advanced Age-Related Macular Degeneration

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Study Aim

This observational study aims to assess the impact of antioxidant vitamins and zinc therapy on intermediate risk of advanced age-related macular degeneration, with a focus on visual acuity and photographic documentation, while also monitoring for any potential ocular events or adverse effects associated with the treatment.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cataract+3

+ Eye Diseases

+ Lens Diseases

From 50 to 100 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2008
See protocol details

Summary

Principal SponsorNational Eye Institute (NEI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 2, 2008

Actual date on which the first participant was enrolled.

The Age-Related Eye Disease Study (AREDS) and its follow-up are research efforts focused on understanding the progression of age-related macular degeneration (AMD) and cataracts. AMD is a condition that affects the central part of the retina, leading to vision loss, while cataracts cause clouding of the eye's lens. This study initially aimed to identify potential risk factors associated with AMD and cataracts, with a special focus on nutritional factors. The results indicated that a combination of antioxidant vitamins and zinc could reduce the risk of developing advanced AMD and associated vision loss, especially in those with an intermediate risk. Following the completion of the initial trial, participants were invited for an additional five-year follow-up to gather more data on the natural course of AMD and cataracts. In the AREDS2 phase, the study evolved into a multi-center trial evaluating the effects of oral supplementation with high doses of lutein, zeaxanthin, and omega-3 fatty acids as treatments for AMD, cataracts, and moderate vision loss. Participants undergo regular ocular examinations, and the study records historical data at each visit. The primary outcomes of interest are changes in visual acuity and photographic documentation of the two diseases. The study also aims to monitor any adverse effects associated with the AREDS treatment. Participants who complete AREDS2 are invited for annual follow-ups for at least five years to collect additional data.

Official TitleAge-Related Eye Disease Study (AREDS) and AREDS2 Follow-Up
NCT00594672
Principal SponsorNational Eye Institute (NEI)
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

110 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CataractEye DiseasesLens DiseasesMacular DegenerationRetinal DegenerationRetinal Diseases

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
SuspendedOne Study Center