Status:
ENROLLING_BY_INVITATION
Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Novartis
Conditions:
Multiple Sclerosis
Tomography, Optical Coherence
Eligibility:
All Genders
18-70 years
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 neurofilam...
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 t...
Eligibility Criteria
Inclusion
- 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
- be existing patients attending the center and already receiving ofatumumab, be eligible for inclusion, and already undergoing all of the proposed study procedures.
- Willing to sign informed consent
- Willing to undergo phlebotomy
Exclusion
- Uncontrolled Diabetes
- Uncontrolled Hypertension
- Glaucoma
- Refractive errors of +/- 6 diopters
- Other neurologic or ophthalmologic disorders
Key Trial Info
Start Date :
May 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06167642
Start Date
May 22 2023
End Date
March 1 2027
Last Update
June 6 2025
Active Locations (1)
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1
Johns Hopkins
Baltimore, Maryland, United States, 21287