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

Terminated

• Conditions: Age-related Macular Degeneration

• Registration Number: NCT00987129
• Lead Sponsor: Yves Sauve

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2012-03
• Status Verified: 2012-08
• Primary Completion: 2014-03
• Study Completion: 2014-12
• Last Update Submitted: 2015-01-04
• Last Update Posted: 2015-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of dry AMD status according to international classification/grading system.	2 year

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Alberta Retina Consultants; 🇨🇦 Edmonton, Alberta, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada