NCT01819415|CompletedResults
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Sponsor study identifier
interventional
40
1 country
1
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2011
Actual (reported)Study Completion
February 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
August 2011
Actual (reported)February 2013
Actual (reported)March 24, 2013
Actual (reported)March 27, 2013
Actual (reported)June 17, 2013
Actual (reported)Vitreal VEGF Levels.
1 day (At the time of vitreous biopsy)
Lipidomics Profile
1 day (At the time of vitreous biopsy)
Central Foveal Thickness
During at least 12 months of follow-up after vitreous biopsy.
Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
Omega-3 metabolites supplementation
Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.
Maisonneuve Rosemont Hospital
Montreal, Quebec, H1T2M4, Canada
Flavio A Rezende, MD, PhD
Maisonneuve-Rosemont Hospital
40 participants (actual enrollment reported by the registry).
First Submitted
March 24, 2013
First Posted
March 27, 2013
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
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Primary Completion
August 2011
Actual (reported)Study Completion
February 2013
Actual (reported)Last Updated
April 24, 2017
Results First Posted
June 17, 2013
Record last verified: 2017-03
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Source: ClinicalTrials.gov.
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