NCT00987129

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 6, 2015

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

September 29, 2009

Last Update Submit

January 4, 2015

Conditions

Age-related Macular Degeneration

Keywords

DHAEPAAMDdrusenomega-3 fatty acidsomega6:omega3 ratio

Outcome Measures

Primary Outcomes (1)

  • Progression of dry AMD status according to international classification/grading system.

    2 year

Secondary Outcomes (1)

  • Delayed progression to neovascular AMD (NVAMD) or Central Geographic Atrophy (cGA) in the fellow eye.

    5 years

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • + years of age
  • NVAMD (Wet) in one eye, early or intermediate dry-AMD in the fellow eye
  • taking AREDS vitamins (or equivalent)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alberta Retina Consultants

Edmonton, Alberta, T5H 0X5, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2H7, Canada

Location

Related Publications (7)

  • 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.

    PMID: 19508997BACKGROUND

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

    PMID: 19227095BACKGROUND

  • 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.

    PMID: 19123156BACKGROUND

  • 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.

    PMID: 18779490BACKGROUND

  • 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.

    PMID: 18689376BACKGROUND

  • 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.

    PMID: 18469279BACKGROUND

  • 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.

    PMID: 18450596BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for genotyping and measuring omega-3 FA status. Serum for Cytokine level analysis.

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Yves SauvĂ©, PhD

    Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, AHFMR Senior Scholar, Ophthalmology Assistant Professor, University of Alberta

Study Record Dates

First Submitted

September 29, 2009

First Posted

September 30, 2009

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Study Completion

December 1, 2014

Last Updated

January 6, 2015

Record last verified: 2012-08

Locations

CA(3)