N/A
Completed N=40
Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
Exudative Age Related Macular Degeneration
Source: ClinicalTrials.gov NCT01819415 ↗
Enrolled (actual)
40
Serious AEs
—
Results posted
Jun 2013
Primary outcomePrimary: Vitreal VEGF Levels. — 735.48; 626.09; 141.11; 235.81 pg/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vitreal VEGF Levels. |
735.48; 626.09; 141.11; 235.81 | — |
| PRIMARY Lipidomics Profile |
— | — |
| SECONDARY Central Foveal Thickness |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT01819415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.