ClinicalTrials.gg
Not yet recruitingNCT07704294MS PredictorUpdated Jul 15, 2026

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

An observational study in Optic Neuritis, Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder, sponsored by King's College London. Not yet recruiting at 3 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Primary conditionNeuromyelitis OpticaRegistry: Optic NeuritisReclassifiedWhy we changed it
Registry
Optic Neuritis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Neuromyelitis Optica
Why
  1. The study's listed conditions name Neuromyelitis Optica, a narrower term within Optic Neuritis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by King's College London · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
180
Ages
16 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Neuromyelitis Optica with a site in United Kingdom — 4 open to participants now, 4 under way, 1 of them phase 3. Neuromyelitis Optica · United Kingdom.

Started
2026
with 1 other
Observational
3 of 12
2 open now
Registered
12th of 12
by date
Lead sponsor
1 of 12
King's College London

Among the 12 studies in Neuromyelitis Optica with a site in United Kingdom, this one is one of 2 that started in 2026, is one of 3 observational ones, and was the 12th registered.

Neuromyelitis Optica

178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.

Browse Neuromyelitis Optica studies →

Open to participants now

4 of the 12 studies in Neuromyelitis Optica with a site in United Kingdom are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 50 Neuromyelitis Optica studies recruiting now, 29 (58%) set no upper age limit and 16 (32%) stop at 75 or younger; 11 take children under 18; 9 take healthy volunteers.

This study: 16 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Neuromyelitis Optica with a site in United Kingdom, or all of them as a file.
02

Study 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. 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:

  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
03

Conditions studied

  • Optic Neuritis
  • Multiple Sclerosis
  • Neuromyelitis Optica Spectrum Disorder
  • Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders
  • Sarcoid

Keywords

  • Optic neuritis
  • Multiple sclerosis
  • MS
  • Genetic Risk Score
  • Risk Prediction
  • Myelin Oligodendrocyte Glycoprotein
  • MOG Antibody Disease
  • Neuromyelitis Optica Spectrum Disorder
04

In context

Neuromyelitis Optica Reclassified

178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.

This study's planned enrollment of 180 is close to the median of 200 across 62 observational studies indexed under Neuromyelitis Optica.

Browse Neuromyelitis Optica studies →

Lead sponsor

King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.

Compared within Neuromyelitis Optica, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Optic Neuritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
06

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
180 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Participants Who Have Experienced Optic Neuritis

    Participants 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.

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    Not applicable - No intervention as this is an observation study

07

What researchers measure

Primary outcomes

  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.

    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.

Secondary outcomes

  1. Visual Acuity (LogMAR)

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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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).

    Time frame: 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).

    Time frame: 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)

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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)

    Time frame: 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.

    Time frame: Baseline recruitment and repeated at 3-12 months later

08

Study locations

3 sites
09

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2026
First posted
Jul 15, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Jul 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07704294
Collaborators
Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Trust, Moorfields Eye Hospital NHS Foundation Trust
Responsible party
Sponsor
First posted
Jul 15, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Jul 15, 2026

Study contacts

Tasanee Braithwaite, Doctor of Medicine (Oxon)
Contact
tasanee.braithwaite@kcl.ac.uk
+44 20 7188 7188
Tasanee Braithwaite
principal investigator · King's College London

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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