Omega 6:Omega 3 Ratio and Progression of Age-related Macular Degeneration (AMD).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00987129
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : September 30, 2009
Last Update Posted : January 6, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Yves Sauve, University of Alberta

September 29, 2009
September 30, 2009
January 6, 2015
March 2012
March 2014   (Final data collection date for primary outcome measure)
Progression of dry AMD status according to international classification/grading system. [ Time Frame: 2 year ]
Reduction or no change in the number of drusen in the retina. [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00987129 on Archive Site
Delayed progression to neovascular AMD (NVAMD) or Central Geographic Atrophy (cGA) in the fellow eye. [ Time Frame: 5 years ]
Delayed progression of wet-age-related macular degeneration. [ Time Frame: 5 years ]
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Omega 6:Omega 3 Ratio and Progression of Age-related Macular Degeneration (AMD).
Effect of Omega-6:Omega-3 Fatty Acid Ratio on Delaying Progression of Age-related Macular Degeneration (AMD) in Moderate to High Risk Individuals.
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Whole blood for genotyping and measuring omega-3 FA status. Serum for Cytokine level analysis.
Non-Probability Sample
Men and women with Neovascular (wet) AMD in one eye and early or intermediate dry AMD in the fellow eye, taking AREDS vitamins (or equivalent).
Age-related Macular Degeneration
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
MOP 79278
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Yves Sauve, University of Alberta
Yves Sauve
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Yves Sauvé, PhD Department of Ophthalmology
University of Alberta
August 2012