Exudative Age Related Macular Degeneration
Conditions
Keywords
wet AMD, Omega-3, VEGF, Lipidomics, DHA, EPA
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.
Interventions
DIETARY_SUPPLEMENTAnti-VEGF plus AREDS-2
Omega-3 metabolites supplementation
DIETARY_SUPPLEMENTAnti-VEGF plus AREDS-1
Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.
Sponsors
Fonds de recherche en ophtalmologie de l'Université de Montréal
Foundation Fighting Blindness
Retina Foundation of Canada
Insight Instruments
Synergetics Inc
Novartis
Maisonneuve-Rosemont Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vitreal VEGF Levels. | 1 day (At the time of vitreous biopsy) |
| Lipidomics Profile | 1 day (At the time of vitreous biopsy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Foveal Thickness | During at least 12 months of follow-up after vitreous biopsy. | Measured with spectral-domain optical coherence tomography. |
Countries
Canada
Participant flow
Recruitment details
Recruitment dates: February-August 2011 Location: Maisonneuve-Rosemont Hospital, University of Montreal, Quebec, Canada
Pre-assignment details
At least 3 months of no other treatments for wet-AMD in groups 1 and 2 and no treatment at all for group 3.
Participants by arm
| Arm | Count |
|---|---|
| Group 3 - Naive Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls. | 10 |
| Group 2 - Anti-VEGF Plus AREDS-1 Supplementation. Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula. | 10 |
| Group 1 - Anti-VEGF Plus AREDS-2 Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA). | 10 |
| Group 4 - Control Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls. | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Group 2 - Anti-VEGF Plus AREDS-1 Supplementation. | Group 1 - Anti-VEGF Plus AREDS-2 | Group 3 - Naive | Group 4 - Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Age | 79.00 years STANDARD_DEVIATION 1.98 | 79.6 years STANDARD_DEVIATION 1.81 | 83.38 years STANDARD_DEVIATION 2.32 | 68.25 years STANDARD_DEVIATION 3.56 | 77.56 years STANDARD_DEVIATION 2.42 |
| Region of Enrollment Canada | 10 participants | 10 participants | 10 participants | 10 participants | 40 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 3 Participants | 8 Participants | 20 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 7 Participants | 2 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Lipidomics Profile
Time frame: 1 day (At the time of vitreous biopsy)
Primary
Vitreal VEGF Levels.
Time frame: 1 day (At the time of vitreous biopsy)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 3 - Naive | Vitreal VEGF Levels. | 735.48 pg/ml |
| Group 2 - Anti-VEGF Plus AREDS-1 Supplementation. | Vitreal VEGF Levels. | 626.09 pg/ml |
| Group 1 - Anti-VEGF Plus AREDS-2 | Vitreal VEGF Levels. | 141.11 pg/ml |
| Group 4 - Control | Vitreal VEGF Levels. | 235.81 pg/ml |
Secondary
Central Foveal Thickness
Measured with spectral-domain optical coherence tomography.
Time frame: During at least 12 months of follow-up after vitreous biopsy.