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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2011

Detailed Description

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.

Interventions

  • Dietary Supplement: Anti-VEGF plus AREDS-2
    • Omega-3 metabolites supplementation
  • Dietary Supplement: Anti-VEGF plus AREDS-1
    • Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.

Arms, Groups and Cohorts

  • No Intervention: Naive
    • Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
  • Active Comparator: Anti-VEGF plus AREDS-1 supplementation.
    • Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
  • Experimental: Anti-VEGF plus AREDS-2
    • Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
  • No Intervention: Control
    • Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.

Clinical Trial Outcome Measures

Primary Measures

  • Vitreal VEGF Levels.
    • Time Frame: 1 day (At the time of vitreous biopsy)
  • Lipidomics Profile
    • Time Frame: 1 day (At the time of vitreous biopsy)

Secondary Measures

  • Central Foveal Thickness
    • Time Frame: During at least 12 months of follow-up after vitreous biopsy.
    • Measured with spectral-domain optical coherence tomography.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maisonneuve-Rosemont Hospital
  • Collaborator
    • Fonds de recherche en ophtalmologie de l’Université de Montréal
  • Provider of Information About this Clinical Study
    • Principal Investigator: Flavio Rezende, Chief of Retina Service, Department of Ophthalmology, University of Montreal – Maisonneuve-Rosemont Hospital
  • Overall Official(s)
    • Flavio A Rezende, MD, PhD, Principal Investigator, Maisonneuve-Rosemont Hospital

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