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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Exudative Age Related Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: Anti-VEGF plus AREDS-2
* Dietary Supplement: Anti-VEGF plus AREDS-1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Naive<br>Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls. | |
| Active Comparator: Anti-VEGF plus AREDS-1 supplementation.<br>Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula. | Dietary Supplement: Anti-VEGF plus AREDS-1<br>* Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.<br>|
| Experimental: Anti-VEGF plus AREDS-2<br>Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA). | Dietary Supplement: Anti-VEGF plus AREDS-2<br>* Omega-3 metabolites supplementation<br>|
| No Intervention: Control<br>Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitreal VEGF Levels. |  | 1 day (At the time of vitreous biopsy) | 
| Lipidomics Profile |  | 1 day (At the time of vitreous biopsy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Foveal Thickness | Measured with spectral-domain optical coherence tomography. | During at least 12 months of follow-up after vitreous biopsy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wet AMD, Omega-3, VEGF, Lipidomics, DHA, EPA