Clinical trial NCT01819415: Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
Official title: Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exudative Age Related Macular Degeneration
Keywords: wet AMD
Omega-3
VEGF
Lipidomics
DHA
EPA
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
Collaborators: name: Fonds de recherche en ophtalmologie de l'Université de Montréal
name: Foundation Fighting Blindness
name: Retina Foundation of Canada
name: Insight Instruments
name: Synergetics Inc
name: Novartis
First posted: 2013-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vitreal VEGF Levels.
timeFrame: 1 day (At the time of vitreous biopsy)
measure: Lipidomics Profile
timeFrame: 1 day (At the time of vitreous biopsy)
Secondary outcomes:
measure: Central Foveal Thickness
timeFrame: During at least 12 months of follow-up after vitreous biopsy.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Flavio A Rezende, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: