Antioxidant Systems and Age-Related Macular Degeneration

NCT ID: NCT00668213

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2010-06-30

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 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

Conditions

Macular Degeneration

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Paul Sternberg

Professor & Chairman of Ophthalmology-Associate Dean for Adult Clinical Affairs Chief Medical Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Sternberg, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt Eye Institute

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22381365 (View on PubMed)

Other Identifiers

060471

Identifier Type: -

Identifier Source: org_study_id