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临床试验/NCT00987129
NCT00987129终止不适用

Effect of Omega-6:Omega-3 Fatty Acid Ratio on Delaying Progression of Age-related Macular Degeneration (AMD) in Moderate to High Risk Individuals.

Yves Sauve3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
200
试验地点
3
主要终点
Progression of dry AMD status according to international classification/grading system.

研究概览

简要总结

Docosahexaenoic acid (DHA) supplementation has been shown to prevent specific age-related changes in the retina through biochemical and functional evaluations, but it is unclear whether increased DHA intake-reflected through elevated DHA+EPA blood levels-can affect the natural history and progression of age-related macular degeneration (AMD). AMD is a disease affecting the macula, the part of the eye containing cone photoreceptors at the center of the visual field. The macula is responsible for vision in most daily functions, including reading, seeing fine details, and colour recognition. Severe AMD can lead to a central scotoma, severely impairing daily functioning. AMD can be divided into two forms: the more severe wet AMD, consisting of proliferation of new blood vessels in the retina, and dry AMD characterized by the development of drusen, a buildup of extracellular material . The investigators are focused on the group with the highest risk of developing the two advanced forms of AMD [wet AMD or central geographic atrophy]: patients with unilateral wet AMD and dry AMD in their other eye. The study will consist of following up a cohort of such subjects and monitoring their visual function in a comprehensive manner. Working in concert with clinical ophthalmologists and basic scientists, the investigators will monitor "DHA+EPA" and "Omega6:Omega3 fatty acid ratio" levels in the blood, inherited predispositions through genetic analysis, lipofuscin (an accumulated waste product) levels & AMD progression via fundus photography, visual acuity, and retinal function via full-field and multifocal electroretinograms. These different factors will be cross-correlated and evaluated to determine how omega-3 fatty acids affect the progression of AMD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 50+ years of age
  • NVAMD (Wet) in one eye, early or intermediate dry-AMD in the fellow eye
  • taking AREDS vitamins (or equivalent)

排除标准

  • Central geographic atrophy
  • Diabetic retinopathy
  • Ocular surgery in the eye with dry-AMD (not including cataract IOL surgery)
  • Underlying ocular pathology in the eye with dry-AMD (especially glaucoma, dense cataracts, and retinitis pigmentosa)

结局指标

主要结局

Progression of dry AMD status according to international classification/grading system.

时间窗: 2 year

次要结局

  • Delayed progression to neovascular AMD (NVAMD) or Central Geographic Atrophy (cGA) in the fellow eye.(5 years)

研究者

发起方
Yves Sauve
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yves Sauve

PhD, AHFMR Senior Scholar, Ophthalmology Assistant Professor, University of Alberta

University of Alberta

研究点 (3)

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