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

NCT ID: NCT06167642

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2027-03-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ofatumumab

Intervention Type: DRUG

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

Interventions

Ofatumumab

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

Intervention Type: DRUG

Other Intervention Names

Kesimpta

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shiv Saidha, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00347678

Identifier Type: -

Identifier Source: org_study_id