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

NCT ID: NCT00987129

Last Updated: 2015-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Age-related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Yves Sauve

OTHER

Sponsor Role lead

Responsible Party

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Yves Sauve

PhD, AHFMR Senior Scholar, Ophthalmology Assistant Professor, University of Alberta

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yves Sauvé, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology

Locations

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Alberta Retina Consultants

Edmonton, Alberta, Canada

Site Status

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Cakiner-Egilmez T. Omega 3 fatty acids and the eye. Insight. 2008 Oct-Dec;33(4):20-5; quiz 26-7.

Reference Type BACKGROUND
PMID: 19227095 (View on PubMed)

Chiu CJ, Klein R, Milton RC, Gensler G, Taylor A. Does eating particular diets alter the risk of age-related macular degeneration in users of the Age-Related Eye Disease Study supplements? Br J Ophthalmol. 2009 Sep;93(9):1241-6. doi: 10.1136/bjo.2008.143412. Epub 2009 Jun 9.

Reference Type BACKGROUND
PMID: 19508997 (View on PubMed)

Querques G, Benlian P, Chanu B, Portal C, Coscas G, Soubrane G, Souied EH. Nutritional AMD treatment phase I (NAT-1): feasibility of oral DHA supplementation in age-related macular degeneration. Eur J Ophthalmol. 2009 Jan-Feb;19(1):100-6. doi: 10.1177/112067210901900115.

Reference Type BACKGROUND
PMID: 19123156 (View on PubMed)

SanGiovanni JP, Chew EY, Agron E, Clemons TE, Ferris FL 3rd, Gensler G, Lindblad AS, Milton RC, Seddon JM, Klein R, Sperduto RD; Age-Related Eye Disease Study Research Group. The relationship of dietary omega-3 long-chain polyunsaturated fatty acid intake with incident age-related macular degeneration: AREDS report no. 23. Arch Ophthalmol. 2008 Sep;126(9):1274-9. doi: 10.1001/archopht.126.9.1274.

Reference Type BACKGROUND
PMID: 18779490 (View on PubMed)

Augood C, Chakravarthy U, Young I, Vioque J, de Jong PT, Bentham G, Rahu M, Seland J, Soubrane G, Tomazzoli L, Topouzis F, Vingerling JR, Fletcher AE. Oily fish consumption, dietary docosahexaenoic acid and eicosapentaenoic acid intakes, and associations with neovascular age-related macular degeneration. Am J Clin Nutr. 2008 Aug;88(2):398-406. doi: 10.1093/ajcn/88.2.398.

Reference Type BACKGROUND
PMID: 18689376 (View on PubMed)

Johnson EJ, Chung HY, Caldarella SM, Snodderly DM. The influence of supplemental lutein and docosahexaenoic acid on serum, lipoproteins, and macular pigmentation. Am J Clin Nutr. 2008 May;87(5):1521-9. doi: 10.1093/ajcn/87.5.1521.

Reference Type BACKGROUND
PMID: 18469279 (View on PubMed)

Huang LL, Coleman HR, Kim J, de Monasterio F, Wong WT, Schleicher RL, Ferris FL 3rd, Chew EY. Oral supplementation of lutein/zeaxanthin and omega-3 long chain polyunsaturated fatty acids in persons aged 60 years or older, with or without AMD. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3864-9. doi: 10.1167/iovs.07-1420. Epub 2008 Apr 30.

Reference Type BACKGROUND
PMID: 18450596 (View on PubMed)

Other Identifiers

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200809MOP-192321

Identifier Type: -

Identifier Source: secondary_id

CIA-CBAA-27683

Identifier Type: -

Identifier Source: secondary_id

MOP 79278

Identifier Type: -

Identifier Source: org_study_id

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