NCT01819415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 17, 2013

Completed
Last Updated

April 24, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

March 24, 2013

Results QC Date

April 28, 2013

Last Update Submit

March 23, 2017

Conditions

Exudative Age Related Macular Degeneration

Keywords

wet AMDOmega-3VEGFLipidomicsDHAEPA

Outcome Measures

Primary Outcomes (2)

  • Vitreal VEGF Levels.

    1 day (At the time of vitreous biopsy)

  • Lipidomics Profile

    1 day (At the time of vitreous biopsy)

Secondary Outcomes (1)

  • Central Foveal Thickness

    During at least 12 months of follow-up after vitreous biopsy.

Study Arms (4)

Naive

NO INTERVENTION

Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.

Anti-VEGF plus AREDS-1 supplementation.

ACTIVE COMPARATOR

Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.

Dietary Supplement: Anti-VEGF plus AREDS-1

Anti-VEGF plus AREDS-2

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Anti-VEGF plus AREDS-2DIETARY_SUPPLEMENT

Omega-3 metabolites supplementation

Anti-VEGF plus AREDS-2
Anti-VEGF plus AREDS-1DIETARY_SUPPLEMENT

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

Anti-VEGF plus AREDS-1 supplementation.

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • wet AMD eligible for intravitreal anti-VEGF treatment.
  • Confirmed exudation on SD-OCT.

You may not qualify if:

  • dry AMD.
  • Disciform scar.
  • Smokers.
  • Morbid obesity.
  • Patients undergoing other forms of treatment for wet AMD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisonneuve Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

Location

Results Point of Contact

Title
Dr. Flavio Rezende
Organization
Maisonneuve-Rosemont Hospital
frezendef@hotmail.com
514-867-2990

Study Officials

  • Flavio A Rezende, MD, PhD

    Maisonneuve-Rosemont Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Retina Service, Department of Ophthalmology, University of Montreal

Study Record Dates

First Submitted

March 24, 2013

First Posted

March 27, 2013

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

February 1, 2013

Last Updated

April 24, 2017

Results First Posted

June 17, 2013

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)