Multiple SclerosisNCT06167642
Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab
An observational study of Multiple Sclerosis and Tomography, Optical Coherence, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Tomography, Optical Coherence, Retinal Degeneration
- What is being tested?
- Ofatumumab
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 75 people with RMS due to commence or already receiving ofatumumab therapy within 60 days of baseline OCT, VA, and blood draw.
Who may be able to join
- 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
Who cannot join
- Uncontrolled Diabetes
- Uncontrolled Hypertension
- Glaucoma
- Refractive errors of +/- 6 diopters
- Other neurologic or ophthalmologic disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis
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.
Read the 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.
- Being tested
- Ofatumumab
- Medical subject headings
- Multiple Sclerosis, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabDrug
Also called Kesimpta
Ofatumumab therapy is part of the patient's clinical care and is not given as part of the study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ganglion cell inner plexiform (GCIP) atrophy in RMS relative to HCs, according to baseline sNfL levels
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.
Measured: at least 12 months for up to 2 years
Secondary outcomes (4)
Inner nuclear layer (INL) atrophy in RMS relative to HCs
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.
Measured: at least 12 months for up to 2 years
Outer nuclear layer (ONL) atrophy in RMS relative to HCs
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.
Measured: at least 12 months for up to 2 years
Differences in the visual function scores
Exploratory analyses within the ofatumumab group will assess changes in visual function scores by baseline sNfL levels utilizing logistic regression.
Measured: at least 12 months for up to 2 years
Differences in expanded disability status scale (EDSS) scores
Exploratory analyses within the ofatumumab group will assess changes in EDSS scores by baseline sNfL levels utilizing logistic regression.
Measured: at least 12 months for up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start22 May 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Shiv Saidha, MBBCh, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167642
- Sponsor's protocol ID
- IRB00347678
- Status last verified
- Jun 2026
- First submitted
- 15 Nov 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Modulation of Retinal Atrophy and Neurofilament Light Chain by Ofatumumab in Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06167642
- Acronym / sponsor ID
- IRB00347678
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 22 May 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with RMS due to commence or already receiving ofatumumab therapy | – | Drug: Ofatumumab75 people with RMS due to commence or already receiving ofatumumab therapy within 60 days of baseline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 75 people with RMS due to commence or already receiving ofatumumab therapy within 60 days of baseline OCT, VA, and blood draw.
Key inclusion criteria (7 listed)
- Between 18 - 70 years of age
- Have RMS as confirmed by the treating neurologist based on the 2017 revised McDonald criteria
- AND Either
- Willing to sign informed consent
- Willing to undergo phlebotomy
Key exclusion criteria (5 listed)
- Uncontrolled Diabetes
- Uncontrolled Hypertension
- Glaucoma
- Refractive errors of +/- 6 diopters
- Other neurologic or ophthalmologic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OfatumumabAlso: KesimptaOfatumumab therapy is part of the patient's clinical care and is not given as part of the study | Drug | People with RMS due to commence or already receiving ofatumumab therapy |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shiv Saidha, MBBCh principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Tomography, Optical Coherence, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.