Multiple Sclerosis Clinical Trial

Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab

Summary

This study aims to assess whether, and the degree to which, ofatumumab modulates or reduces rates of retinal atrophy in people with relapsing-remitting MS (RMS), according to baseline serum neurofilament light chain (sNfL) levels.

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Full Description

Seventy-five people with RMS who due to commence or already receiving ofatumumab therapy within 60 days of baseline will be recruited. All recruited participants will be tracked prospectively over a two-year period. Participants will complete an optical coherence tomography (OCT) scan, visual acuity (VA) assessments, EDSS, and sNfL blood level at baseline and every 6 months. Participants will be tracked prospectively for 2 years. OCT scans, sNfL levels, disability score determinations, 100% high-contrast, 2.5% and 1.25% low-contrast letter acuities will be performed every 6 months. Results from an existing cohort of approximately 75 healthy controls (HC) from a separate study undergoing annual OCT and visual function assessments will be used for comparison purposes.

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Eligibility Criteria

Inclusion Criteria:

Between 18 - 70 years of age

Have RMS as confirmed by the treating neurologist based on the 2017 revised McDonald criteria

AND Either

be due to commence ofatumumab within 60 days of baseline OCT/VA/phlebotomy or
be existing patients attending the center and already receiving ofatumumab, be eligible for inclusion, and already undergoing all of the proposed study procedures.
Willing to sign informed consent
Willing to undergo phlebotomy

Exclusion Criteria:

Uncontrolled Diabetes
Uncontrolled Hypertension
Glaucoma
Refractive errors of +/- 6 diopters
Other neurologic or ophthalmologic disorders

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

75

Study ID:

NCT06167642

Recruitment Status:

Enrolling by invitation

Sponsor:

Johns Hopkins University

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There is 1 Location for this study

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Johns Hopkins
Baltimore Maryland, 21287, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

75

Study ID:

NCT06167642

Recruitment Status:

Enrolling by invitation

Sponsor:


Johns Hopkins University

How clear is this clinincal trial information?

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