Clinical Trials at VRM Toronto
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Our Clinical Trials Department is a crucial part of our medical retina clinic, providing patients with access to the latest and most innovative treatments for retinal conditions. Our team of experienced professionals works closely with leading researchers and industry partners to design and execute clinical trials that are aimed at advancing the field of retina medicine.
Our trials encompass a wide range of conditions, including age-related macular degeneration, diabetic retinopathy, and other retinal diseases. Our goal is to evaluate the safety and efficacy of new treatments, and to provide our patients with access to cutting-edge treatments that are not yet widely available. We work closely with industry partners to develop and explore the role of machine learning and artificial intelligence in our clinical research program to help improve patient outcomes.
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We are dedicated to providing our patients with the highest level of care and prioritize their safety at all times. Our clinical trials are conducted in accordance with the highest ethical and regulatory standards, and our patients are carefully screened and monitored throughout the trial process. Our patients also have the opportunity to contribute to scientific discovery by participating in our trials, and they benefit from being among the first to receive access to innovative treatments.
Research Studies Currently Enrolling:
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INSITE:
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Who is eligible? Patients over age 18 with diabetic macular edema (DME) requiring injections
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Study Medication: Faricimab (Vabysmo)
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Study Overview: The purpose of this study is to determine if DME can be effectively managed with a flexible schedule of injections compared to the standard fixed dosing schedule (every four to eight weeks). If enrolled in the study, you will be randomized to one of these groups. For the purposes of this study, only one of your eyes will be selected for study treatment. However, the doctor will discuss your options with you if you require study treatment in both eyes.
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Procedures performed during study:
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Vision testing
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Retinal imaging
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Physical examination by doctor
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Length of study: 100 weeks (approx 23 months)
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Additional information:
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Study title: ”Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial (INSITE-DME)”
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Web site: https://ichgcp.net/clinical-trials-registry/NCT05610319
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SENSE NG101:
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Who is eligible? Adult patients, 50-80yrs old, with wet age related macular degeneration (wet AMD) requiring injections
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Current treatment for wet AMD: The current standard of care for wet AMD is frequent (sometimes every month or every other month) injections into the eye to stop or slow down wet AMD.
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Study Medication: NG101 is a gene therapy medication that is given only once. It is an adeno-associated virus 8 (AAV8) gene therapy vector (carrier) containing a DNA gene for aflibercept protein. The aflibercept protein produced by NG101 is similar to the wet AMD treatment Eylea.
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Purpose of Study: The main purpose of this research study is to determine if a single injection of the gene therapy NG101 is safe and well-tolerated in patients with wet AMD.
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Procedures performed during study:
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Subretinal injection of NG101 study drug
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Vision testing
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Retinal imaging
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Urine and blood testing
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Physical examination by doctor
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Length of study: Approx. 23 visits over a span of 5 years
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Additional information:
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Study title: “A Phase 1/2a Open-label Study to Evaluate Safety, Tolerability and Preliminary Efficacy of NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration”
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Web site: https://ichgcp.net/clinical-trials-registry/NCT05984927
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ASCENT RGX-314:
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Who is eligible? Adult patients, 50-80yrs old, with wet age related macular degeneration (wet AMD) requiring injections
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Current treatment for wet AMD: The current standard of care for wet AMD is frequent (sometimes every month or every other month) injections into the eye to stop or slow down wet AMD.
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Study Medication: RGX-314 is a gene therapy medication that is given only once. It is an adeno-associated virus 8 (AAV8) gene therapy vector (carrier) containing gene that tells cells in the eye to make a protein that is designed to work in a similar way as current injection therapies for wet AMD (like Eylea) aflibercept protein. The aflibercept protein produced by NG101RGX314 is similar to the wet AMD treatment Eylea.
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Purpose of Study: The purpose of this study is to evaluate whether two different doses of RGX-314 help improve or preserve vision compared to Eylea. In this study, you will either receive RGX-314 or Eylea. If you are assigned to receive RGX-314, you will either receive the low dose or the high dose of RGX-314 that are being evaluated in this study.
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Procedures performed during study:
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Subretinal injection of RGX-314 study drug
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Vision testing
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Retinal imaging
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Urine and blood testing
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Physical examination by doctor
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Length of study: Approx. 2 years
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Additional information:
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Study title: “A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD”
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Web site: https://ichgcp.net/clinical-trials-registry/NCT05407636
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If you are interested in learning more about any of our clinical studies, please contact our Research department at: research@vrmto.com, 647-361-7575.