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| Name | Class |
|---|---|
| Fonds de recherche en ophtalmologie de l'Université de Montréal | OTHER |
| Foundation Fighting Blindness | OTHER |
| Retina Foundation of Canada | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Control | No Intervention | Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-VEGF plus AREDS-2 | Dietary Supplement | Omega-3 metabolites supplementation |
| |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavio A Rezende, MD, PhD | Maisonneuve-Rosemont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maisonneuve Rosemont Hospital | Montreal | Quebec | H1T2M4 | Canada |
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At least 3 months of no other treatments for wet-AMD in groups 1 and 2 and no treatment at all for group 3.
Recruitment dates: February-August 2011 Location: Maisonneuve-Rosemont Hospital, University of Montreal, Quebec, Canada
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 3 - Naive | Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls. |
| FG001 | Group 2 - Anti-VEGF Plus AREDS-1 Supplementation. | Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula. |
| FG002 | 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). |
| FG003 | Group 4 - Control | Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 3 - Naive | Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls. |
| BG001 | Group 2 - Anti-VEGF Plus AREDS-1 Supplementation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vitreal VEGF Levels. | Posted | Number | pg/ml | 1 day (At the time of vitreous biopsy) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 3 - Naive | Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Flavio Rezende | Maisonneuve-Rosemont Hospital | 514-867-2990 | frezendef@hotmail.com |
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| Insight Instruments |
| UNKNOWN |
| Synergetics Inc | UNKNOWN |
| Novartis | INDUSTRY |
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| Anti-VEGF plus AREDS-1 |
| Dietary Supplement |
Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3. |
|
Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
| BG002 | 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). |
| BG003 | Group 4 - Control | Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Group 4 - Control | Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls. |
|
|
| Primary | Lipidomics Profile | Not Posted | 1 day (At the time of vitreous biopsy) | Participants |
| Secondary | Central Foveal Thickness | Measured with spectral-domain optical coherence tomography. | Not Posted | During at least 12 months of follow-up after vitreous biopsy. | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group 2 - Anti-VEGF Plus AREDS-1 Supplementation. | Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula. | 0 | 0 | 0 | 0 |
| EG002 | 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). | 0 | 0 | 0 | 0 |
| EG003 | Group 4 - Control | Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls. | 0 | 0 | 0 | 0 |
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