Antioxidant Systems and Age-Related Macular Degeneration

Macular Degeneration Clinical Trial

Official title:

Antioxidant Systems and Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668213
• Other study ID #: 060471
• Status: Completed
• Phase: N/A
• First received: April 24, 2008
• Last updated: January 8, 2014
• Start date: June 2006
• Est. completion date: June 2010

Study information

• Verified date: January 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Degeneration

Locations

Country	Name	City	State
United States	Vanderbilt Eye Institute	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 years	No