NCT03651362

Brief Summary

This study evaluates the length of optic nerve lesion on 3D-DIR sequence as an imaging biomarker predictive of retinal axonal loss and visual disability, 12 months after the occurence of a first clinical episode of optic neuritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

August 27, 2018

Last Update Submit

December 4, 2025

Conditions

Optic Neuritis

Keywords

optic neuritisDIRvisual disabilityCISmultiple sclerosisNMOSD

Outcome Measures

Primary Outcomes (1)

  • Severity of retinal axonal loss around papilla after a clinical episode of optic neuritis

    peripapillary RNFL thickness decrease

    12 months

Secondary Outcomes (4)

  • Severity of retinal axonal loss within macula after a clinical episode of optic neuritis

    12 months

  • Severity of visual disability after a clinical episode of optic neuritis

    12 months

  • Severity of microstructural architecture of optic nerve after a clinical episode of optic neuritis

    12 months

  • Progression of optic nerve lesion length

    12 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from a recent clinical episode of ON suggestive of demyelinating disease as clinically isolated syndrome, multiple sclerosis or neuromyelitis optica spectrum disorders.

You may qualify if:

  • patient suffering from an acute clinical episode of optic neuritis (ON) confirmed by neurophthalmological examination

You may not qualify if:

  • past history of homolateral episode of ON
  • retinal diseases
  • diabeta mellitus
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

Related Publications (6)

  • Hodel J, Outteryck O, Bocher AL, Zephir H, Lambert O, Benadjaoud MA, Chechin D, Pruvo JP, Vermersch P, Leclerc X. Comparison of 3D double inversion recovery and 2D STIR FLAIR MR sequences for the imaging of optic neuritis: pilot study. Eur Radiol. 2014 Dec;24(12):3069-75. doi: 10.1007/s00330-014-3342-3. Epub 2014 Aug 23.

    PMID: 25149294BACKGROUND

  • Miller DH, Newton MR, van der Poel JC, du Boulay EP, Halliday AM, Kendall BE, Johnson G, MacManus DG, Moseley IF, McDonald WI. Magnetic resonance imaging of the optic nerve in optic neuritis. Neurology. 1988 Feb;38(2):175-9. doi: 10.1212/wnl.38.2.175.

    PMID: 3340276BACKGROUND

  • Dunker S, Wiegand W. Prognostic value of magnetic resonance imaging in monosymptomatic optic neuritis. Ophthalmology. 1996 Nov;103(11):1768-73. doi: 10.1016/s0161-6420(96)30429-6.

    PMID: 8942868BACKGROUND

  • Kallenbach K, Simonsen H, Sander B, Wanscher B, Larsson H, Larsen M, Frederiksen JL. Retinal nerve fiber layer thickness is associated with lesion length in acute optic neuritis. Neurology. 2010 Jan 19;74(3):252-8. doi: 10.1212/WNL.0b013e3181ca0135.

    PMID: 20083802BACKGROUND

  • Trip SA, Schlottmann PG, Jones SJ, Altmann DR, Garway-Heath DF, Thompson AJ, Plant GT, Miller DH. Retinal nerve fiber layer axonal loss and visual dysfunction in optic neuritis. Ann Neurol. 2005 Sep;58(3):383-91. doi: 10.1002/ana.20575.

    PMID: 16075460BACKGROUND

  • Hadhoum N, Hodel J, Defoort-Dhellemmes S, Duhamel A, Drumez E, Zephir H, Pruvo JP, Leclerc X, Vermersch P, Outteryck O. Length of optic nerve double inversion recovery hypersignal is associated with retinal axonal loss. Mult Scler. 2016 Apr;22(5):649-58. doi: 10.1177/1352458515598021. Epub 2015 Jul 30.

    PMID: 26227005RESULT

MeSH Terms

Conditions

Optic NeuritisMultiple Sclerosis

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Olivier Outteryck, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2018

First Posted

August 29, 2018

Study Start

February 1, 2016

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)