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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

Brief Summary:
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.

Condition or disease
Age-related Macular Degeneration

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Omega-6:Omega-3 Fatty Acid Ratio on Delaying Progression of Age-related Macular Degeneration (AMD) in Moderate to High Risk Individuals.
Study Start Date : March 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Progression of dry AMD status according to international classification/grading system. [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Delayed progression to neovascular AMD (NVAMD) or Central Geographic Atrophy (cGA) in the fellow eye. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Whole blood for genotyping and measuring omega-3 FA status. Serum for Cytokine level analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00987129

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Canada, Alberta
Alberta Retina Consultants
Edmonton, Alberta, Canada, T5H 0X5
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
University of Alberta
Edmonton, Alberta, Canada, T6G 2H7
Sponsors and Collaborators
Yves Sauve
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Yves Sauvé, PhD Department of Ophthalmology


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Responsible Party: Yves Sauve, PhD, AHFMR Senior Scholar, Ophthalmology Assistant Professor, University of Alberta, University of Alberta Identifier: NCT00987129    
Other Study ID Numbers: MOP 79278
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: August 2012
Keywords provided by Yves Sauve, University of Alberta:
omega-3 fatty acids
omega6:omega3 ratio
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases