NCT03656055

Brief Summary

This study will interest in the pathophysiology of silent retinal axonal loss in multiple sclerosis. Recent studies have suggested that silent retinal axonal loss (no past history of optic neuritis \[ON\]) may be due to inflammatory lesions within the optic radiations and a transsynaptic degenerative process. The objective is to measure the exact role of silent optic nerve lesion in the occurrence of silent retinal axonal loss by performing OCT, brain and optic nerve MRI in a cohort of patients without recent disease activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

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

April 21, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2019

Completed
Last Updated

September 21, 2022

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

August 27, 2018

Last Update Submit

September 20, 2022

Conditions

Multiple Sclerosis

Keywords

MRIaxonal lossMSOCT

Outcome Measures

Primary Outcomes (1)

  • Study of asymptomatic retinal atrophy in multiple sclerosis and asymptomatic optic nerve demyelinating lesion

    The temporal peripapillary Retinal Nerve Fiber Layer thickness (pRNFL; quantitative data) measured on optical coherence tomography will evaluate asymptomatic retinal atrophy Presence of subclinical optic nerve lesion will be assessed on optic nerve MRI (3D-double inversion recovery sequence; Y/N; qualitative data) and according to clinical information (past history of optic neuritis \[ON\] or not). It will enable investigators to define 3 eyes' groups: eyes' group with symptomatic optic nerve lesion (ON eyes), eyes' group with asymptomatic optic nerve lesion (NON eyes with asymptomatic lesion) and eyes' group without symptomatic or asymptomatic lesion (NON eyes without lesion). Investigators will proceed to comparison of temporal pRNFL between NON eyes with asymptomatic lesion and NON eyes without lesion

    Day 1 (cross-sectional study)

Secondary Outcomes (4)

  • Evaluation of the link between asymptomatic retinal atrophy in multiple sclerosis and intensity of demyelinating process all along the optic ways (from the retina to the visual cortex)

    Day 1 (cross-sectional study)

  • Evaluation of the link between symptomatic retinal atrophy in multiple sclerosis and intensity of demyelinating process all along the optic ways (from the retina to the visual cortex)

    Day 1 (cross-sectional study)

  • Evaluation of the link between retinal atrophy and visual connectivity

    Day 1 (cross-sectional study)

  • Evaluation of the link between visual disability and MRI parameters measuring intensity of demyelinating process all along the optic ways (from the retina to the visual cortex)

    Day 1 (cross-sectional study)

Eligibility Criteria

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

RRMS treated by natalizumab for more than 6 months in order to measure patients with a lower risk of relapse

You may qualify if:

  • Relapsing Remitting Multiple Sclerosis (RRMS) patients treated by natalizumab for more than 6 months
  • JohnCunninghamVirus (JCV) index \< 0.9
  • patients followed in our MS center from the beginning of the disease

You may not qualify if:

  • ophthalmologic diseases
  • diabetes mellitus
  • contra-indication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHRU

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

  • 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: 26227005BACKGROUND

  • Gabilondo I, Martinez-Lapiscina EH, Martinez-Heras E, Fraga-Pumar E, Llufriu S, Ortiz S, Bullich S, Sepulveda M, Falcon C, Berenguer J, Saiz A, Sanchez-Dalmau B, Villoslada P. Trans-synaptic axonal degeneration in the visual pathway in multiple sclerosis. Ann Neurol. 2014 Jan;75(1):98-107. doi: 10.1002/ana.24030. Epub 2014 Jan 2.

    PMID: 24114885BACKGROUND

  • Jindahra P, Petrie A, Plant GT. The time course of retrograde trans-synaptic degeneration following occipital lobe damage in humans. Brain. 2012 Feb;135(Pt 2):534-41. doi: 10.1093/brain/awr324. Epub 2012 Feb 1.

    PMID: 22300877BACKGROUND

  • Petzold A, Balcer LJ, Calabresi PA, Costello F, Frohman TC, Frohman EM, Martinez-Lapiscina EH, Green AJ, Kardon R, Outteryck O, Paul F, Schippling S, Vermersch P, Villoslada P, Balk LJ; ERN-EYE IMSVISUAL. Retinal layer segmentation in multiple sclerosis: a systematic review and meta-analysis. Lancet Neurol. 2017 Oct;16(10):797-812. doi: 10.1016/S1474-4422(17)30278-8. Epub 2017 Sep 12.

    PMID: 28920886BACKGROUND

  • Martinez-Lapiscina EH, Arnow S, Wilson JA, Saidha S, Preiningerova JL, Oberwahrenbrock T, Brandt AU, Pablo LE, Guerrieri S, Gonzalez I, Outteryck O, Mueller AK, Albrecht P, Chan W, Lukas S, Balk LJ, Fraser C, Frederiksen JL, Resto J, Frohman T, Cordano C, Zubizarreta I, Andorra M, Sanchez-Dalmau B, Saiz A, Bermel R, Klistorner A, Petzold A, Schippling S, Costello F, Aktas O, Vermersch P, Oreja-Guevara C, Comi G, Leocani L, Garcia-Martin E, Paul F, Havrdova E, Frohman E, Balcer LJ, Green AJ, Calabresi PA, Villoslada P; IMSVISUAL consortium. Retinal thickness measured with optical coherence tomography and risk of disability worsening in multiple sclerosis: a cohort study. Lancet Neurol. 2016 May;15(6):574-84. doi: 10.1016/S1474-4422(16)00068-5. Epub 2016 Mar 18.

    PMID: 27011339BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating 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

September 4, 2018

Study Start

April 21, 2017

Primary Completion

January 3, 2018

Study Completion

January 3, 2019

Last Updated

September 21, 2022

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)