Clinical trial NCT06167642: Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab
Official title: Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Multiple Sclerosis
Tomography, Optical Coherence
Retinal Degeneration
Visual Acuity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2023-12-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 75 people with RMS due to commence or already receiving ofatumumab therapy within 60 days of baseline OCT, VA, and blood draw.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levels
timeFrame: at least 12 months for up to 2 years
Secondary outcomes:
measure: Inner nuclear layer (INL) atrophy in RMS relative to HCs
timeFrame: at least 12 months for up to 2 years
measure: Outer nuclear layer (ONL) atrophy in RMS relative to HCs
timeFrame: at least 12 months for up to 2 years
measure: Differences in the visual function scores
timeFrame: at least 12 months for up to 2 years
measure: Differences in expanded disability status scale (EDSS) scores
timeFrame: at least 12 months for up to 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Shiv Saidha, MBBCh
role: PRINCIPAL_INVESTIGATOR
References: