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

Johns Hopkins University

Status: Invitation-only

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

Treatments: Drug: Ofatumumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06167642

IRB00347678

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 1 patient group

People with RMS due to commence or already receiving ofatumumab therapy

Description:

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

Treatment:

Drug: Ofatumumab