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

Maisonneuve-Rosemont Hospital

Status: Completed

Conditions: Exudative Age Related Macular Degeneration

Treatments: Dietary Supplement: Anti-VEGF plus AREDS-1; Dietary Supplement: Anti-VEGF plus AREDS-2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01819415

HMR-10059

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Naive

No Intervention group

Description:

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

Anti-VEGF plus AREDS-1 supplementation.

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Anti-VEGF plus AREDS-1

Anti-VEGF plus AREDS-2

Experimental group

Description:

Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).

Treatment:

Dietary Supplement: Anti-VEGF plus AREDS-2

Control

No Intervention group

Description:

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