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

NCT06167642 | Enrolling By Invitation

• 1 other identifier: IRB00347678
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Tomography, Optical Coherence; Retinal Degeneration; Visual Acuity

Outcome Measures

Primary Outcomes (1)

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

  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.

  at least 12 months for up to 2 years

Secondary Outcomes (4)

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

  at least 12 months for up to 2 years

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

  at least 12 months for up to 2 years

• Differences in the visual function scores

  at least 12 months for up to 2 years

• Differences in expanded disability status scale (EDSS) scores

  at least 12 months for up to 2 years

Study Arms (1)

People with RMS due to commence or already receiving ofatumumab therapy

75 people with RMS due to commence or already receiving ofatumumab therapy within 60 days of baseline.

Drug: Ofatumumab

Interventions

Ofatumumab DRUG

Ofatumumab therapy is part of the patient's clinical care and is not given as part of the study

Also known as: Kesimpta

People with RMS due to commence or already receiving ofatumumab therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Willing to sign informed consent
• Willing to undergo phlebotomy

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Novartis: collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Retinal Degeneration

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Study Officials

• Shiv Saidha, MBBCh

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 12, 2023
• Study Start: May 22, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

US (1)