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

March 23, 2017 updated by: Flavio Rezende, Maisonneuve-Rosemont Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T2M4
        • Maisonneuve Rosemont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Dietary supplement: Anti-VEGF plus AREDS-1
Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.
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).
Dietary supplement: Anti-VEGF plus AREDS-2
Omega-3 metabolites supplementation
No Intervention: Control
Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Collaborators

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

Investigators

  • Principal Investigator: Flavio A Rezende, MD, PhD, Maisonneuve-Rosemont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 24, 2013

First Submitted That Met QC Criteria

March 26, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR-10059

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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