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

January 4, 2015 updated by: Yves Sauve

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada, T5H 0X5
        • Alberta Retina Consultants
      • Edmonton, Alberta, Canada, T6G 2H7
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression of dry AMD status according to international classification/grading system.
Time Frame: 2 year
2 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yves Sauve

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Yves Sauvé, PhD, Department of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (ESTIMATE)

September 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 4, 2015

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOP 79278
  • 200809MOP-192321
  • CIA-CBAA-27683

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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