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Antioxidant Systems and Age-Related Macular Degeneration

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Paul Sternberg, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00668213
First received: April 24, 2008
Last updated: January 8, 2014
Last verified: January 2014

April 24, 2008
January 8, 2014
June 2006
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00668213 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Antioxidant Systems and Age-Related Macular Degeneration
Antioxidant Systems and Age-Related Macular Degeneration

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.

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
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood serum

Probability Sample

Subjects at risk of macular degeneration

Macular Degeneration
Not Provided
Not Provided
Brantley MA Jr, Osborn MP, Sanders BJ, Rezaei KA, Lu P, Li C, Milne GL, Cai J, Sternberg P Jr. The short-term effects of antioxidant and zinc supplements on oxidative stress biomarker levels in plasma: a pilot investigation. Am J Ophthalmol. 2012 Jun;153(6):1104-9.e2. doi: 10.1016/j.ajo.2011.12.010. Epub 2012 Mar 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
55 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00668213
060471
No
Paul Sternberg, Vanderbilt University
Vanderbilt University
National Institutes of Health (NIH)
Principal Investigator: Paul Sternberg, MD Vanderbilt University
Vanderbilt University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP