Eye scans could reveal hidden clues about MS drug effectiveness
NCT ID NCT06864936
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study will test whether a special eye scan (OCT) can detect changes in the retina that show how well the MS drug ublituximab is working. Researchers will compare 15 people starting ublituximab with 15 people on other MS treatments. The goal is to find a new, non-invasive way to monitor treatment response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ublituximab
- What this could lead to
- If successful, this could lead to a new way to monitor MS treatment response using simple eye scans, potentially improving care.
- What could go wrong
- This is a small, early-stage study focused on biomarkers, not on proving the drug works. The new imaging method may not prove useful in practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: For Ublituximab Group: 1. Ages 18-65 2. A diagnosis of relapsing MS (to include relapsing-remitting MS and active secondary progressive MS) according to 2017 Revised McDonald Criteria. 3. A recent referral for initiation of ublituximab for treatment of MS by the patient's treating physician. For Comparison Group: 1. Ages 18 - 65 2. A diagnosis of relapsing-remitting MS according to 2017 Revised McDonald Criteria. 3. Currently on a stable dose of disease modifying treatment for MS with no plans for alternative therapy for the following year. Exclusion Criteria: For Ublituximab Group: 1. Known eye disease that may, in the opinion of the screening ophthalmologist, preclude proper analysis of data in this study. This includes, but is not limited to diabetic retinopathy, macular degeneration, and glaucoma. 2. Treatment with any B-cell depleting disease modifying therapy for MS (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months. 3. History of life-threatening infusion reaction on ublituximab or prior anti-CD20 therapy 4. Any chronic or active infection that would preclude anti-CD20 therapy. This may include but is not limited to active hepatitis B virus (HBV) confirmed by positive results for Hepatitis B surface antigen (HBsAg) and anti-HBV tests, tuberculosis, and human immunodeficiency virus (HIV). 5. Receipt of any live of live-attenuated vaccines within 4 weeks prior to first ublituximab administration For Comparison Group: 1. Known eye disease that may, in the opinion of the screening ophthalmologist, preclude proper analysis of data in this study. This includes, but is not limited to diabetic retinopathy, macular degeneration, and glaucoma. 2. Treatment with any B-cell depleting disease modifying therapy (i.e. rituximab, ocrelizumab, ofatumumab, ublituximab, etc.) within the past 12 months, or plans to initiate such a therapy in the following year.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Maryland, Baltimore
RECRUITINGBaltimore, Maryland, 21201, United States
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