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OpenTrials
Enrolling by Invitation

NCT Number: NCT06167642

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

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.

Enrolling by Invitation

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Eye Diseases, Hereditary Immune System Diseases Nervous System Diseases Retinal Degeneration Retinal Diseases Tomography, Optical Coherence Visual Acuity

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ofatumumab

Drug

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

Other names: Kesimpta

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

    Time frame: at least 12 months for up to 2 years

    Rates of INL 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.

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

    Time frame: at least 12 months for up to 2 years

    Rates of INL and ONL 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.

  3. Differences in the visual function scores

    Time frame: at least 12 months for up to 2 years

    Exploratory analyses within the ofatumumab group will assess changes in visual function scores by baseline sNfL levels utilizing logistic regression.

  4. Differences in expanded disability status scale (EDSS) scores

    Time frame: at least 12 months for up to 2 years

    Exploratory analyses within the ofatumumab group will assess changes in EDSS scores by baseline sNfL levels utilizing logistic regression.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Novartis

Registry information

Official study title

Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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