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临床试验/NCT00668213
NCT00668213已完成不适用

Antioxidant Systems and Age-Related Macular Degeneration

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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.

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Sternberg

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

Vanderbilt University

研究点 (1)

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