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Completed

NCT Number: NCT01819415

Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD

The purpose of this trial is to detect the influence of omega-3 supplements on vitreous levels of vascular endothelial growth factor (VEGF) in exudative age-related macular degeneration (AMD) in patients receiving intravitreal anti-VEGF treatment. Patients are randomized to receive either Age-Related Eye Disease Study 1(AREDS-1) supplements formula with the addition of Lutein or AREDS-2 supplementation that adds Omega-3 metabolites (DHA and EPA) to the formula. Our goal is to take a limited volume of vitreous sample from these patients previous to their regular anti-VEGF injection and perform a comprehensive cytokines and lipidomic profiling. We hypothesize, based on our previous basic science discovery of a potent anti-VEGF action of an Omega-3 metabolite (4-HDHA), that lipid metabolite composition and metobolite levels will significantly vary according to VEGF levels. Based on the results of this pioneering clinical study, our research team will proceed to evaluate the individual anti-angiogenic (vessel growth stopping) properties of the predominant Omega-3 metabolites found.

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Key information

Conditions

Exudative Age Related Macular Degeneration

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maisonneuve Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

About this study

The purpose of this trial is to detect the influence of omega-3 supplements on vitreous levels of vascular endothelial growth factor (VEGF) in exudative age-related macular degeneration (AMD) in patients receiving intravitreal anti-VEGF treatment. Patients are randomized to receive either Age-Related Eye Disease Study 1(AREDS-1) supplements formula with the addition of Lutein or AREDS-2 supplementation that adds Omega-3 metabolites (DHA and EPA) to the formula. Our goal is to take a limited volume of vitreous sample from these patients previous to their regular anti-VEGF injection and perform a comprehensive cytokines and lipidomic profiling. We hypothesize, based on our previous basic science discovery of a potent anti-VEGF action of an Omega-3 metabolite (4-HDHA), that lipid metabolite composition and metobolite levels will significantly vary according to VEGF levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • wet AMD eligible for intravitreal anti-VEGF treatment.
  • Confirmed exudation on SD-OCT.

Exclusion criteria

  • dry AMD.
  • Disciform scar.
  • Smokers.
  • Morbid obesity.
  • Patients undergoing other forms of treatment for wet AMD.

Treatment and study plan

Anti-VEGF plus AREDS-2

Dietary Supplement

Omega-3 metabolites supplementation

Anti-VEGF plus AREDS-1

Dietary Supplement

Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.

Primary outcomes

  1. Vitreal VEGF Levels.

    Time frame: 1 day (At the time of vitreous biopsy)

  2. Lipidomics Profile

    Time frame: 1 day (At the time of vitreous biopsy)

Secondary outcomes

  1. Central Foveal Thickness

    Time frame: During at least 12 months of follow-up after vitreous biopsy.

    Measured with spectral-domain optical coherence tomography.

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Collaborators

  • Fonds de recherche en ophtalmologie de l'Université de Montréal
  • Foundation Fighting Blindness
  • Insight Instruments
  • Novartis
  • Retina Foundation of Canada
  • Synergetics Inc

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2013
First posted
Mar 27, 2013
Registry last updated
Apr 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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