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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Alberta
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Yves Sauve, University of Alberta
ClinicalTrials.gov Identifier:
NCT00987129
First received: September 29, 2009
Last updated: August 26, 2012
Last verified: August 2012

September 29, 2009
August 26, 2012
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 ] [ Designated as safety issue: No ]
Reduction or no change in the number of drusen in the retina. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00987129 on ClinicalTrials.gov Archive Site
Delayed progression to neovascular AMD (NVAMD) or Central Geographic Atrophy (cGA) in the fellow eye. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Delayed progression of wet-age-related macular degeneration. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2017
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)
Both
50 Years and older
No
Contact: Ioannis Dimopoulos, MD 780-4929596 dimopoul@ualberta.ca
Canada
 
NCT00987129
MOP 79278, 200809MOP-192321, CIA-CBAA-27683
Yes
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP