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

Not Applicable

Completed

• Conditions: Exudative Age Related Macular Degeneration
• Interventions: Dietary Supplement: Anti-VEGF plus AREDS-1; Dietary Supplement: Anti-VEGF plus AREDS-2

• Registration Number: NCT01819415
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief 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.

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 Timeline

• Study Start: 2011-02
• Primary Completion: 2011-08
• Study Completion: 2013-02
• Study First Submitted: 2013-03-24
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-27
• Results First Submitted: 2013-04-28
• Results First Submitted QC: 2013-04-28
• Results First Posted: 2013-06-17
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-VEGF plus AREDS-1 supplementation.	Anti-VEGF plus AREDS-1	Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
Anti-VEGF plus AREDS-2	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).

Primary Outcome Measures

Name	Time	Method
Lipidomics Profile	1 day (At the time of vitreous biopsy)
Vitreal VEGF Levels.	1 day (At the time of vitreous biopsy)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maisonneuve Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada