Exudative Age-related Macular Degeneration. Clinical Trial
| Verified date | April 2013 |
| Source | Maisonneuve-Rosemont Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | February 2013 |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Maisonneuve Rosemont Hospital | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Maisonneuve-Rosemont Hospital | Centre de Recherche en Ophtalmologie, Université de Montréal, Foundation Fighting Blindness, Insight Instruments, Novartis, Retina Foundation of Canada, Synergetics Inc |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vitreal VEGF Levels. | 1 day (At the time of vitreous biopsy) | No | |
| Primary | Lipidomics Profile | 1 day (At the time of vitreous biopsy) | No | |
| Secondary | Central Foveal Thickness | Measured with spectral-domain optical coherence tomography. | During at least 12 months of follow-up after vitreous biopsy. | No |