Status:
COMPLETED
Antioxidant Systems and Age-Related Macular Degeneration
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Macular Degeneration
Eligibility:
All Genders
55-85 years
Brief 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 wer...
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 vi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00668213
Start Date
June 1 2006
End Date
June 1 2010
Last Update
January 10 2014
Active Locations (1)
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1
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232-8808