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Antioxidant Systems and Age-Related Macular Degeneration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00668213
First received: April 24, 2008
Last updated: April 22, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition
Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Antioxidant Systems and Age-Related Macular Degeneration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood serum


Estimated Enrollment: 140
Study Start Date: June 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects at risk of macular degeneration

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668213

Contacts
Contact: Paul Sternberg, MD 615-936-2020 paul.sternberg@vanderbilt.edu
Contact: Sandy A Owings, COA, CCRP 615-936-1474 sandy.owings@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt Eye Institute Recruiting
Nashville, Tennessee, United States, 37232-8808
Contact: Sandy A Owings, COA, CCRP     615-936-1474     sandy.owings@vanderbilt.edu    
Principal Investigator: Paul Sternberg, MD            
Sponsors and Collaborators
Vanderbilt University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Paul Sternberg, MD Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Paul Sternberg, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00668213     History of Changes
Other Study ID Numbers: 060471
Study First Received: April 24, 2008
Last Updated: April 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013