NCT06167642

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

Enrolling by Invitation
Not specifiedAges 18–70Observational
Johns Hopkins University
~75 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Ofatumumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levels
Measured over at least 12 months for up to 2 years
Multiple Sclerosis
Tomography, Optical Coherence
Retinal Degeneration
Visual Acuity
1 sites across 1 states
Maryland1
  • Shiv Saidha, MBBCh · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Uncontrolled Diabetes
Uncontrolled Hypertension
Glaucoma
Refractive errors of +/- 6 diopters
Other neurologic or ophthalmologic disorders
  • Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levelsat least 12 months for up to 2 years

    Rates of of GCIP layer thinning (µm/year) will be assessed according to baseline sNfL levels using mixed-effects linear regression models with random subject and eye-specific random intercepts and random slopes in time, using time from baseline OCT visit (in years) as a continuous variable in both unadjusted models (including time, sNfL group and their interaction) and models adjusted for the cross-sectional and longitudinal effects of covariates (age, sex, race, and history of optic neuritis) by including these variables and their respective interactions with time.