Antioxidant Systems and Age-Related Macular Degeneration

January 8, 2014 updated by: Paul Sternberg, Vanderbilt University

Objective:

The objective of this study was to determine whether the antioxidant supplements used in AREDS shifted the plasma pool of the AREDS subjects to a more reduced state. The AREDS subjects were randomly assigned to one of four treatment groups:

  1. antioxidants (500mg Vitamin C, 4000IU Vitamin E, 15mg beta carotene)
  2. zinc (80mg zinc oxide, 2mg cupric oxide)
  3. antioxidants plus zinc;
  4. placebo.

None of the subjects received supplemental GSH or cyst (e) ine.

Age-related macular degeneration (AMD) is the leading cause of severe visual impairment in elderly Americans, with an estimated 15 million people having some form of this disease. AMD primarily affects the central vision and many patients develop severe visual handicaps.

Currently there are no clear established understandings of the etiology or pathogenesis of this disease.

Study Overview

Status

Completed

Conditions

Detailed Description

Inclusion Criteria

  • Age 55-80
  • 70 Participants with Intermediate or Advanced AMD
  • 70 participants with no ocular signs of AMD
  • Willing to give written informed consent, make the required study visits, and follow instructions
  • Any race and either sex

Exclusion Criteria

  • Current history of a medical condition that would preclude scheduled study visits or completion of the study (e.g., unstable cardiovascular disease, unstable pulmonary disease, chronic hepatitis, or AIDS).
  • Current or history of an ophthalmic disease in the study eye (other than AMD) that would likely compromise or during follow-up could likely compromise the visual acuity of the study eye (e.g., amblyopia, uncontrolled glaucoma with an IOP > 30mmHg, ischemic optic neuropathy, proliferative diabetic retinopathy, clinically relevant nonproliferative diabetic retinopathy, clinically relevant diabetic macular edema, significant active uveitis).
  • Clinical signs of myopic retinopathy, or a refraction of > -8 diopter power in current prescription
  • Aphakic or psuedophakic patients may be enrolled if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the patient's cataract surgery of either myopic retinopathy or a refraction of > -8 diopters.
  • Intraocular surgery in study eye (eye to be treated) within 60 days prior to enrollment
  • Presence of a scleral buckle in the study eye
  • Currently participating or has participated in a clinical trial that utilized an investigational drug or treatment within 30 days prior to administration of study medication. Daily vitamins and/or mineral therapy are allowed.
  • Known medical history of allergy or sensitivity to any component of the drug formulation and/or fluorescein dye that is clinically significant in the investigator's opinion.
  • Patient is on oral anticoagulant therapy of Coumadin

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-8808
        • Vanderbilt Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects at risk of macular degeneration

Description

Inclusion Criteria:

  • Age 55-80
  • 70 Participants with Intermediate or Advanced AMD
  • 70 participants with no ocular signs of AMD
  • Willing to give written informed consent, make the required study visits, and follow instructions
  • Any race and either sex

Exclusion Criteria:

  • Current history of a medical condition that would preclude scheduled study visits or completion of the study (e.g., unstable cardiovascular disease, unstable pulmonary disease, chronic hepatitis, or AIDS).
  • Current or history of an ophthalmic disease in the study eye (other than AMD) that would likely compromise or during follow-up could likely compromise the visual acuity of the study eye (e.g., amblyopia, uncontrolled glaucoma with an IOP > 30mmHg, ischemic optic neuropathy, proliferative diabetic retinopathy, clinically relevant nonproliferative diabetic retinopathy, clinically relevant diabetic macular edema, significant active uveitis).
  • Clinical signs of myopic retinopathy, or a refraction of > -8 diopter power in current prescription
  • Aphakic or psuedophakic patients may be enrolled if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the patient's cataract surgery of either myopic retinopathy or a refraction of > -8 diopters.
  • Intraocular surgery in study eye (eye to be treated) within 60 days prior to enrollment
  • Presence of a scleral buckle in the study eye
  • Currently participating or has participated in a clinical trial that utilized an investigational drug or treatment within 30 days prior to administration of study medication. Daily vitamins and/or mineral therapy are allowed.
  • Known medical history of allergy or sensitivity to any component of the drug formulation and/or fluorescein dye that is clinically significant in the investigator's opinion.
  • Patient is on oral anticoagulant therapy of Coumadin

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The purpose of this study is to find out if there are changes in the blood that would make you at risk for having age related macular degeneration.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Paul Sternberg, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

April 24, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060471

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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