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

NCT ID: NCT01819415

Last Updated: 2017-04-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Exudative Age Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Naive

Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.

Group Type NO_INTERVENTION

No interventions assigned to this group

Anti-VEGF plus AREDS-1 supplementation.

Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.

Group Type ACTIVE_COMPARATOR

Anti-VEGF plus AREDS-1

Intervention Type DIETARY_SUPPLEMENT

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

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).

Group Type EXPERIMENTAL

Anti-VEGF plus AREDS-2

Intervention Type DIETARY_SUPPLEMENT

Omega-3 metabolites supplementation

Control

Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Anti-VEGF plus AREDS-2

Omega-3 metabolites supplementation

Intervention Type DIETARY_SUPPLEMENT

Anti-VEGF plus AREDS-1

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fonds de recherche en ophtalmologie de l'Université de Montréal

OTHER

Sponsor Role collaborator

Foundation Fighting Blindness

OTHER

Sponsor Role collaborator

Retina Foundation of Canada

UNKNOWN

Sponsor Role collaborator

Insight Instruments

UNKNOWN

Sponsor Role collaborator

Synergetics Inc

UNKNOWN

Sponsor Role collaborator

Novartis

INDUSTRY

Sponsor Role collaborator

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Flavio Rezende

Chief of Retina Service, Department of Ophthalmology, University of Montreal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Flavio A Rezende, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

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Maisonneuve Rosemont Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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HMR-10059

Identifier Type: -

Identifier Source: org_study_id

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