Antioxidant Systems and Age-Related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      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.
    

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
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects at risk of macular degeneration
      
Biospecimen description: 
      Blood serum
    
Keywords: Macular Degeneration