Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ofatumumab.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Tomography, Optical Coherence, Retinal Degeneration, Visual Acuity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis
Overview
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.
Interventions
- Drug Ofatumumab
Ofatumumab therapy is part of the patient's clinical care and is not given as part of the study
Primary outcome measures
- Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levels [Time frame: at least 12 months for up to 2 years]
Secondary outcome measures (4)
- Inner nuclear layer (INL) atrophy in RMS relative to HCs [Time frame: at least 12 months for up to 2 years]
- Outer nuclear layer (ONL) atrophy in RMS relative to HCs [Time frame: at least 12 months for up to 2 years]
- Differences in the visual function scores [Time frame: at least 12 months for up to 2 years]
- Differences in expanded disability status scale (EDSS) scores [Time frame: at least 12 months for up to 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Uncontrolled Diabetes
- Uncontrolled Hypertension
- Glaucoma
- Refractive errors of +/- 6 diopters
- Other neurologic or ophthalmologic disorders
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Johns Hopkins — Baltimore
Identifiers
NCT: NCT06167642 · IRB00347678