The purpose of the research study is to explore new retinal imaging biomarkers of immune cell activity in MS during use of ublituximab (Briumvi) treatment. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. This study will evaluate the efficacy of ublituximab to modulate MS pathology in a new manner. In order to assess this new biomarker, a specialized optical coherence tomography (OCT) scan will be performed at enrollment into the study and at 2 other timepoints throughout the study. Subjects asked to take part in this study should have been diagnosed with relapsing multiple sclerosis (MS) and have recently been advised to start the medication ublituximab (Briumvi) or are currently on another medication for the treatment of their MS. We plan to enroll 30 patients into this study. Fifteen (15) patients with Relapsing Remitting Multiple Sclerosis (RRMS) who are being initiated on B-cell depletion therapy by their treating physician at the University of Maryland Center for MS Treatment and Research will be offered enrollment into this study. Additionally, 15 age/sex matched patients with stable RRMS who are not undergoing any change in treatment and are not currently on B-cell depleting therapies will be enrolled as control subjects.
Age range
18 Years – 65 Years
Sex
ALL
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Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Evaluation of the effect of ublituximab on macular hyperreflective foci (HRF) in MS.
Timeframe: From enrollment until the last OCT at Months 6 and 12
Evaluation of the effect of ublituximab on inner limiting membrane (ILM) macrophage-like cells (MLC).
Timeframe: From enrollment until the last OCT at Months 6 and 12