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Optic NeuritisMS PredictorNCT07704294

Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool

An observational study of Optic Neuritis and Multiple Sclerosis, run by King's College London at 3 sites in United Kingdom.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to determine whether genetic information, together with clinical information, can be used to improve prediction of future multiple sclerosis (MS) diagnosis after a first-time episode of optic neuritis. Read more about this study

Who is it for?
Ages 16 years and older
How many people
180 participants
Where
3 sitesUnited Kingdom
Study dates
1 Sep 2026to 1 Dec 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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants aged 16 and above with a history of a first episode of optic neuritis recruited from one of the three participating NHS sites in London (Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Foundation Trust and Moorfields Eye Hospital NHS Foundation Trust)

Who may be able to join

  • Aged 16 years and above at time of consent
  • Previous episode of optic neuritis diagnosed at one of the participating sites

Who cannot join

  • Patients for whom data relating to the first episode of ON are not available in the medical record at a participating site
  • Children <16 years at the time of recruitment

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tasanee Braithwaite, Doctor of Medicine (Oxon) contact

+44 20 7188 7188

tasanee.braithwaite@kcl.ac.uk

United Kingdom3 sites

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD

    Neringa Jurkute, MD, PhD, FEBOphth, +44 20 7253 3411, n.jurkute@nhs.net

    Neringa Jurkute, MD, PhD, FEBOphth

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH

    Tasanee Braithwaite, FRCOphth, +44 20 7188 7188, tasanee.braithwaite@kcl.ac.uk

    Tasanee Braithwaite, FRCOphth

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

    James McHugh, FRCOphth, +44 20 3299 9000, james.mchugh@kcl.ac.uk

    James McHugh, FRCOphth

Other trials in United Kingdom

About this study

Official title: Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool (MS Predictor)

The goal of this observational study is to determine whether genetic information, together with clinical information, can be used to improve prediction of future multiple sclerosis (MS) diagnosis after a first-time episode of optic neuritis. The study will also investigate visual outcomes, quality of life, healthcare use, and the acceptability of using genetic information to predict future health outcomes in people with optic neuritis.

The main outcomes that we aim to assess are:

Read more
  1. Incident diagnosis of MS following a first episode of optic neuritis, including time to MS diagnosis.
  2. Visual outcomes following optic neuritis, including visual acuity, visual field, and colour vision.
  3. Clinical care received following optic neuritis, including specialist review, investigations/tests
  4. Health-related and vision-related quality of life.
  5. Health economic impacts and healthcare utilisation after experiencing optic neuritis
  6. Knowledge, attitudes, and practices/behaviours about using genetic information to predict future MS disease risk.

If consented, participants will:

  1. Allow researchers to review information from their medical records relating to their optic neuritis diagnosis, investigations, treatments, and outcomes.
  2. Be invited to provide a saliva sample for genetic analysis.
  3. Complete questionnaires about their lifestyle/risk factors, quality of life, and views on genetic risk prediction.
  4. Allow researchers to track long-term health outcomes using information from their NHS records
Being tested
No Intervention: Observational Cohort
Keywords
Optic neuritis, Multiple sclerosis, MS, Genetic Risk Score, Risk Prediction, Myelin Oligodendrocyte Glycoprotein, MOG Antibody Disease, Neuromyelitis Optica Spectrum Disorder
Medical subject headings
Optic Neuritis, Multiple Sclerosis, Neuromyelitis Optica, Sarcoidosis, Genetic Risk Score

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Intervention: Observational CohortOther

    Not applicable - No intervention as this is an observation study

Study groups in NCT07704294
Study groupRoleWhat they receive
Participants Who Have Experienced Optic NeuritisParticipants with a history of a first episode of optic neuritis recruited from the 3 participating NHS hospitals. Participants will undergo retrospective review of clinical records, complete questionnaires, and may provide a saliva sample for genetic analysis. Participants will be invited to consent to longer term prospective outcome assessment.
Receives: Other: No Intervention: Observational Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis

    Occurrence of a diagnosis of multiple sclerosis following a first episode of optic neuritis.

    Measured: Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period.

Secondary outcomes (19)

  1. Visual Acuity (LogMAR)

    Visual acuity (LogMAR) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments.

    Measured: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).

  2. Visual Field Mean Deviation (dB)

    Visual field mean deviation (Decibels) measured at first diagnosis of optic neuritis and at subsequent follow-up assessments

    Measured: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).

  3. Colour Vision (Number of Ishihara Plates Correctly Identified)

    Colour vision assessed using Ishihara pseudoisochromatic plates and reported as the number of plates correctly identified.

    Measured: From the date of first optic neuritis diagnosis until the last available follow-up assessment (up to 15 years).

  4. Number of Healthcare Consultations Following Optic Neuritis Diagnosis

    Number of healthcare consultations attended following optic neuritis diagnosis, reported by consultation type, including primary care appointments, emergency department attendances, neuro-ophthalmology, neurology, and other relevant specialist clinics.

    Measured: 12 months

  5. Number of Investigations Performed Following Optic Neuritis Diagnosis

    Number of investigations performed following optic neuritis diagnosis, reported by investigation type, including OCT, visual field testing, MRI, VEP, blood tests, and CSF analysis.

    Measured: 12 months

  6. Time to Diagnostic Investigations Following Optic Neuritis Diagnosis (Days)

    Time interval (days) from optic neuritis diagnosis to each investigation, reported by investigation type.

    Measured: 12 months

  7. Time to Treatment Following Optic Neuritis Diagnosis (Days)

    Time interval (Days) from optic neuritis diagnosis to initiation of first treatment course, reported by treatment type.

    Measured: 12 months

  8. Number of Treatment Episodes Following Optic Neuritis Diagnosis

    Number of treatment episodes received following optic neuritis diagnosis, reported by treatment type (e.g. intravenous corticosteroids, oral corticosteroids, plasma exchange, intravenous immunoglobulin, disease-modifying therapies).

    Measured: 12 months

  9. Health-Related Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire [EQ-5D-5L])

    Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five domains, each scored on five levels. Higher levels indicate worse health status and poorer health-related quality of life.

    Measured: Measured at baseline recruitment and repeated 3-12 months later

  10. Vision-Related Quality of Life (National Eye Institute Visual Function Questionnaire-25 [NEI-VFQ-25])

    Vision-related quality of life assessed using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) composite score. Scores range from 0 to 100, with higher scores indicating better vision-related quality of life.

    Measured: Baseline and repeated 3-12 months later

  11. Optic Neuritis-Related Quality of Life (Semi-Structured Questionnaire)

    Participant-reported optic neuritis-related quality of life and lived experiences, including symptoms, treatment impacts, emotional well-being, activities of daily living, social participation and personal relationships, explored using a bespoke semi-structured questionnaire

    Measured: Measured at baseline recruitment and repeated 3-12 months later

  12. Fatigue (Patient-Reported Outcomes Measurement Information System [PROMIS] Fatigue 6a)

    Fatigue assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 6a instrument. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10 in the reference population. Higher scores indicate greater fatigue (worse outcome).

    Measured: Baseline recruitment and repeated once 3-12 months later

  13. Depression (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression 4a)

    Depression assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 4a instrument. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10 in the reference population. Higher scores indicate more severe depressive symptoms (worse outcome).

    Measured: Baseline recruitment and repeated once 3-12 months later

  14. Work Productivity Loss (Adapted iMTA Productivity Cost Questionnaire [iPCQ])

    Participant-reported work productivity loss associated with optic neuritis or related diseases, including absenteeism, presenteeism and changes to employment. Measured using the Adapted iMTA Productivity Cost Questionnaire (iPCQ)

    Measured: Baseline recruitment and repeated once 3-12 months later

  15. Healthcare Resource Utilisation: Appointments, Emergency Department Attendances and Hospital Admissions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])

    Participant-reported utilisation of healthcare services related to optic neuritis or associated diseases, including appointments with healthcare professionals, emergency department attendances, and hospital admissions

    Measured: Baseline recruitment and repeated once 3-12 months later

  16. Healthcare Resource Utilisation: Investigations and Treatment Interventions (Adapted iMTA Medical Consumption Questionnaire [iMCQ])

    Participant-reported utilisation of diagnostic investigations and therapeutic interventions related to optic neuritis or associated diseases, including imaging, laboratory investigations, electrophysiological testing, and treatments received.

    Measured: Baseline recruitment and repeated once 3-12 months later

  17. Informal Care Received (Hours)

    Participant-reported hours of informal care received from family members, friends or acquaintances because of optic neuritis or associated diseases.

    Measured: Baseline recruitment and repeated once 3-12 months later

  18. Out-of-Pocket Costs (Pounds Sterling)

    Participant-reported personal expenditure related to optic neuritis and associated diseases in the first year after optic neuritis began (e.g. health insurance, prescription costs, optician/sight tests, low vision aids)

    Measured: Baseline recruitment and repeated once 3-12 months later

  19. Knowledge, Attitudes and Practices/Behaviours Regarding Genetic Risk Prediction (KAP Questionnaire)

    This will be explored using a knowledge, attitudes and practices/behaviour questionnaire to explore how participants feel about the use of genetic information to predict future health outcome risk including multiple sclerosis.

    Measured: Baseline recruitment and repeated at 3-12 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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
Retrospective
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07704294
Sponsor's protocol ID
352834
Other IDs
222
Acronym
MS Predictor
Status last verified
Jun 2026
First submitted
18 Jun 2026
Last updated
15 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Panthagani J, O'Donovan C, Aiyegbusi OL, Liu X, Bayliss S, Calvert M, Pesudovs K, Denniston AK, Moore DJ, Braithwaite T. Evaluating patient-reported outcome measures (PROMs) for future clinical trials in adult patients with optic neuritis. Eye (Lond). 2023 Oct;37(15):3097-3107. doi: 10.1038/s41433-023-02478-z. Epub 2023 Mar 17.

    PubMed 36932161

  • Braithwaite T, Wiegerinck N, Petzold A, Denniston A. Vision Loss from Atypical Optic Neuritis: Patient and Physician Perspectives. Ophthalmol Ther. 2020 Jun;9(2):215-220. doi: 10.1007/s40123-020-00247-9. Epub 2020 Mar 21.

    PubMed 32200476

  • Laviers H, Petzold A, Braithwaite T. How far should I manage acute optic neuritis as an ophthalmologist? A United Kingdom perspective. Eye (Lond). 2024 Aug;38(12):2238-2245. doi: 10.1038/s41433-024-03164-4. Epub 2024 Jun 12.

    PubMed 38867071

  • Petzold A, Braithwaite T, van Oosten BW, Balk L, Martinez-Lapiscina EH, Wheeler R, Wiegerinck N, Waters C, Plant GT. Case for a new corticosteroid treatment trial in optic neuritis: review of updated evidence. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):9-14. doi: 10.1136/jnnp-2019-321653. Epub 2019 Nov 18. No abstract available.

    PubMed 31740484

  • Braithwaite T, Subramanian A, Petzold A, Galloway J, Adderley NJ, Mollan SP, Plant GT, Nirantharakumar K, Denniston AK. Trends in Optic Neuritis Incidence and Prevalence in the UK and Association With Systemic and Neurologic Disease. JAMA Neurol. 2020 Dec 1;77(12):1514-1523. doi: 10.1001/jamaneurol.2020.3502.

    PubMed 33017023

  • Loginovic P, Wang F, Li J, Ferrat L, Mirshahi UL, Rao HS, Petzold A, Tyrrell J, Green HD, Weedon MN, Ganna A, Tuomi T, Carey DJ; UKBB Eye & Vision Consortium; FinnGen; Geisinger-Regeneron DiscovEHR Collaboration; Oram RA, Braithwaite T. Applying a genetic risk score model to enhance prediction of future multiple sclerosis diagnosis at first presentation with optic neuritis. Nat Commun. 2024 Feb 28;15(1):1415. doi: 10.1038/s41467-024-44917-9.

    PubMed 38418465

Questions about this trial

What is this clinical trial studying?

An observational study of Optic Neuritis and Multiple Sclerosis, run by King's College London at 3 sites in United Kingdom.

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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. 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?

Contact Tasanee Braithwaite, Doctor of Medicine (Oxon) (+44 20 7188 7188, tasanee.braithwaite@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incident Multiple Sclerosis Diagnosis Following a First Episode of Optic Neuritis (time frame: Extracted from retrospective record at baseline, and reviewed before study end to capture any new events occurring during the 12 month study period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07704294, which also lists 6 linked publications.

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 15 Jul 2026.

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