Trials / Completed
CompletedNCT01819415
Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Maisonneuve-Rosemont Hospital · Academic / Other
- Sex
- All
- Age
- 50 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Anti-VEGF plus AREDS-2 | Omega-3 metabolites supplementation |
| DIETARY_SUPPLEMENT | Anti-VEGF plus AREDS-1 | Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3. |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2011-08-01
- Completion
- 2013-02-01
- First posted
- 2013-03-27
- Last updated
- 2017-04-24
- Results posted
- 2013-06-17
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT01819415. Inclusion in this directory is not an endorsement.