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

Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis
Enrolling by invitationRelapsing MSNCT06167642

What it found

Still running

No result yet.

What was tested

Treatment tested

What it measured

Main measures

  • Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levels

    at least 12 months for up to 2 years

    Brain volume lossRetina scans (OCT)

Other measures (4)

  • Inner nuclear layer (INL) atrophy in RMS relative to HCs

    at least 12 months for up to 2 years

    Brain volume lossRetina scans (OCT)

  • Outer nuclear layer (ONL) atrophy in RMS relative to HCs

    at least 12 months for up to 2 years

    Brain volume lossRetina scans (OCT)

  • Differences in the visual function scores

    at least 12 months for up to 2 years

    Vision

  • Differences in expanded disability status scale (EDSS) scores

    at least 12 months for up to 2 years

    Disability progression

Who could take part

Relapsing MS · 18 to 70

Inclusion Criteria: 1. Between 18 - 70 years of age 2. 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. 3. Willing to sign informed consent 4. Willing to undergo phlebotomy Exclusion Criteria: * Uncontrolled Diabetes * Uncontrolled Hypertension * Glaucoma * Refractive errors of +/- 6 diopters * Other neurologic or ophthalmologic disorders

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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Related trials

History

    1. Started

      May 2023

    2. Main results due

      Mar 2027

    3. Finished

      Mar 2027

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