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

Primary Purpose

Exudative Age Related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Anti-VEGF plus AREDS-2
Anti-VEGF plus AREDS-1
Sponsored by
Maisonneuve-Rosemont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age Related Macular Degeneration focused on measuring wet AMD, Omega-3, VEGF, Lipidomics, DHA, EPA

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Maisonneuve Rosemont Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Experimental

No Intervention

Arm Label

Naive

Anti-VEGF plus AREDS-1 supplementation.

Anti-VEGF plus AREDS-2

Control

Arm Description

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).

Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.

Outcomes

Primary Outcome Measures

Vitreal VEGF Levels.
Lipidomics Profile

Secondary Outcome Measures

Central Foveal Thickness
Measured with spectral-domain optical coherence tomography.

Full Information

First Posted
March 24, 2013
Last Updated
March 23, 2017
Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Fonds de recherche en ophtalmologie de l'Université de Montréal, Foundation Fighting Blindness, Retina Foundation of Canada, Insight Instruments, Synergetics Inc, Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01819415
Brief Title
Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
Official Title
Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maisonneuve-Rosemont Hospital
Collaborators
Fonds de recherche en ophtalmologie de l'Université de Montréal, Foundation Fighting Blindness, Retina Foundation of Canada, Insight Instruments, Synergetics Inc, Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age Related Macular Degeneration
Keywords
wet AMD, Omega-3, VEGF, Lipidomics, DHA, EPA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naive
Arm Type
No Intervention
Arm Description
Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
Arm Title
Anti-VEGF plus AREDS-1 supplementation.
Arm Type
Active Comparator
Arm Description
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
Arm Title
Anti-VEGF plus AREDS-2
Arm Type
Experimental
Arm Description
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
Intervention Type
Dietary Supplement
Intervention Name(s)
Anti-VEGF plus AREDS-2
Intervention Description
Omega-3 metabolites supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
Anti-VEGF plus AREDS-1
Intervention Description
Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.
Primary Outcome Measure Information:
Title
Vitreal VEGF Levels.
Time Frame
1 day (At the time of vitreous biopsy)
Title
Lipidomics Profile
Time Frame
1 day (At the time of vitreous biopsy)
Secondary Outcome Measure Information:
Title
Central Foveal Thickness
Description
Measured with spectral-domain optical coherence tomography.
Time Frame
During at least 12 months of follow-up after vitreous biopsy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio A Rezende, MD, PhD
Organizational Affiliation
Maisonneuve-Rosemont Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maisonneuve Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T2M4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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