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

NCT01819415 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-04-24

Study results available
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Summary

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.

Conditions

  • Exudative Age Related Macular Degeneration

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.

Sponsors & Collaborators

  • Fonds de recherche en ophtalmologie de l'Université de Montréal

    collaborator OTHER

  • Foundation Fighting Blindness

    collaborator OTHER

  • Retina Foundation of Canada

    collaborator UNKNOWN

  • Insight Instruments

    collaborator UNKNOWN

  • Synergetics Inc

    collaborator UNKNOWN

  • Novartis

    collaborator INDUSTRY

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Flavio A Rezende, MD, PhD · Maisonneuve-Rosemont Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-08-31
Completion
2013-02-28

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01819415 on ClinicalTrials.gov