Omega 6:Omega 3 Ratio and Progression of Age-related Macular Degeneration (AMD).
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.
|Study Design:||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.|
- Progression of dry AMD status according to international classification/grading system. [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- Delayed progression to neovascular AMD (NVAMD) or Central Geographic Atrophy (cGA) in the fellow eye. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood for genotyping and measuring omega-3 FA status. Serum for Cytokine level analysis.
|Study Start Date:||March 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987129
|Alberta Retina Consultants|
|Edmonton, Alberta, Canada, T5H 0X5|
|Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T5H 3V9|
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2H7|
|Principal Investigator:||Yves Sauvé, PhD||Department of Ophthalmology|