CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Anti-VEGF plus AREDS-2 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01819415
NCT01819415N/ACompleted

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

Maisonneuve-Rosemont Hospital·interventional·Posted Mar 27, 2013·Updated Apr 24, 2017

In Brief

A clinical study evaluating Anti-VEGF plus AREDS-2 and Anti-VEGF plus AREDS-1 for Exudative Age Related Macular Degeneration. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2013
Enrollment StartFeb 1, 2011
Primary CompletionAug 1, 2011
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.3 years ago

Interventions

Anti-VEGF plus AREDS-2dietary

Omega-3 metabolites supplementation

Anti-VEGF plus AREDS-1dietary

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