Exudative Age Related Macular DegenerationNCT01819415
Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
A study testing Anti-VEGF plus AREDS-2 and Anti-VEGF plus AREDS-1 in people with Exudative Age Related Macular Degeneration, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Exudative Age Related Macular Degeneration
- What is being tested?
- Anti-VEGF plus AREDS-2 and Anti-VEGF plus AREDS-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- wet AMD eligible for intravitreal anti-VEGF treatment.
- Confirmed exudation on SD-OCT.
Who cannot join
- dry AMD.
- Disciform scar.
- Smokers.
- Morbid obesity.
- Patients undergoing other forms of treatment for wet AMD.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Anti-VEGF plus AREDS-2, Anti-VEGF plus AREDS-1
- Keywords
- wet AMD, Omega-3, VEGF, Lipidomics, DHA, EPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-VEGF plus AREDS-2Dietary supplement
Omega-3 metabolites supplementation
Anti-VEGF plus AREDS-1Dietary supplement
Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitreal VEGF Levels.
Measured: 1 day (At the time of vitreous biopsy)
Lipidomics Profile
Measured: 1 day (At the time of vitreous biopsy)
Secondary outcomes (1)
Central Foveal Thickness
Measured with spectral-domain optical coherence tomography.
Measured: During at least 12 months of follow-up after vitreous biopsy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exudative Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de recherche en ophtalmologie de l'Université de Montréal, Foundation Fighting Blindness, Retina Foundation of Canada, Insight Instruments, Synergetics Inc, Novartis
- Responsible party
- Principal investigator, Flavio Rezende, Maisonneuve-Rosemont Hospital
- Investigators
- Flavio A Rezende, MD, PhD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819415
- Sponsor's protocol ID
- HMR-10059
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2013
- Last updated
- 24 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Supplementation and Vitreal VEGF Levels in Wet-AMD
- ClinicalTrials.gov ID
- NCT01819415
- Acronym / sponsor ID
- HMR-10059
- Keywords
- wet AMD, Omega-3, VEGF, Lipidomics, DHA, EPA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Fonds de recherche en ophtalmologie de l'Université de Montréal, Foundation Fighting Blindness, Retina Foundation of Canada, Insight Instruments, Synergetics Inc, Novartis
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Posted 17 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Anti-VEGF plus AREDS-1Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula. |
| Anti-VEGF plus AREDS-2 | Experimental | Dietary Supplement: Anti-VEGF plus AREDS-2Patients 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. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- wet AMD eligible for intravitreal anti-VEGF treatment.
- Confirmed exudation on SD-OCT.
Key exclusion criteria (5 listed)
- dry AMD.
- Disciform scar.
- Smokers.
- Morbid obesity.
- Patients undergoing other forms of treatment for wet AMD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-VEGF plus AREDS-2Omega-3 metabolites supplementation | Dietary supplement | Anti-VEGF plus AREDS-2 |
| Anti-VEGF plus AREDS-1Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3. | Dietary supplement | Anti-VEGF plus AREDS-1 supplementation. |
Primary outcome
Vitreal VEGF Levels.
Time frame: 1 day (At the time of vitreous biopsy)
Lipidomics Profile
Time frame: 1 day (At the time of vitreous biopsy)
1 secondary outcome
Central Foveal Thickness
Time frame: During at least 12 months of follow-up after vitreous biopsy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavio A Rezende, MD, PhD principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-VEGF plus AREDS-2 and Anti-VEGF plus AREDS-1 in people with Exudative Age Related Macular Degeneration, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitreal VEGF Levels. (time frame: 1 day (At the time of vitreous biopsy)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.