AzTrials
AzTrials

Multiple SclerosisVWIMSNCT03656055

Analysis of Neurodegenerative Process Within Visual Ways In Multiple Sclerosis

An observational study of Multiple Sclerosis, run by University Hospital, Lille at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
How many people
108 participants
Where
1 siteFrance
Study dates
21 Apr 2017to 3 Jan 2019
Phase
Observational
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Roger Salengro, CHRU

    Lille

Other trials in France

About this study

Official title: Study of the Link Between Retinal Atrophy and Demyelinating Inflammatory Processes on Visual Pathways in Relapsing Multiple Sclerosis in Magnetic Resonance Imaging and Optical Coherence Tomography

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.

Read the detailed description

This study will interest in the neurodegenerative process reported in multiple sclerosis within the visual ways.

Symptomatic and asymptomatic retinal axonal loss in multiple sclerosis (MS) have largely been described. Many recent optical coherence tomography (OCT) studies have suggested that subclinical retinal axonal loss (no past history of optic neuritis [ON]) observed in MS mainly due to inflammatory and demyelinating lesions within the optic radiations and a retrograde transsynaptic degenerative process. None of these studies clearly tried to investigate the role of asymptomatic optic nerve lesion(s) in subclinical retinal axonal loss occurence.

The main objective of the study 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. The study will focus on a cohort of patients without recent disease activity in order to exclude or minimize the risk of recent and old lesion occurence on the visual ways, which could be a bias in our analysis.

Keywords
MRI, axonal loss, MS, OCT
Medical subject headings
Multiple Sclerosis

What is being measured

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

  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

    Measured: Day 1 (cross-sectional study)

Secondary outcomes (4)

  1. 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)

    Within NON eyes, investigators will evaluate the imaging parameters on the optic ways which is/are significantly and independently associated to temporal pRNFL (multivariate analysis)

    MRI parameters parameters included will be: length of asymptomatic optic nerve lesion; presence of lesion on chiasma, presence of lesion on optic tracts, T2 lesion burden on optic radiations, fractional anisotropy in optic radiations, volume of primary visual cortex

    Measured: Day 1 (cross-sectional study)

  2. 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)

    Within ON eyes, investigators will evaluate the imaging parameters on the optic ways which is/are significantly and independently associated to temporal pRNFL (multivariate analysis)

    MRI parameters parameters included will be: length of subclinical optic nerve lesion; presence of lesion on chiasma, presence of lesion on optic tracts, T2 lesion burden on optic radiations, fractional anisotropy in optic radiations, volume of primary visual cortex

    Measured: Day 1 (cross-sectional study)

  3. Evaluation of the link between retinal atrophy and visual connectivity

    Within all eyes (ON eyes + NON eyes with asymptomatic optic nerve lesion + NON eyes without asymptomatic lesion), investigators will evaluate the link between the mean temporal pRNFL of both eyes (pRNFL; quantitative data) and the strength of visual connectivity (seed based approach on resting state sequence)

    Measured: Day 1 (cross-sectional study)

  4. 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)

    Within all eyes (ON eyes + NON eyes with asymptomatic optic nerve lesion + NON eyes without asymptomatic lesion), investigators will evaluate the MRI parameters significantly and independently associated to visual disability.

    Visual disability will be measured by low contrast vision acuity (2.5%; unit LogMar)

    MRI parameters will be length of subclinical optic nerve lesion; presence of lesion on chiasma, presence of lesion on optic tracts, T2 lesion burden on optic radiations, fractional anisotropy in optic radiations, volume of primary visual cortex

    Measured: Day 1 (cross-sectional study)

Timeline

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

  1. First posted4 Sep 2018
  2. Study start21 Apr 2017
  3. Primary completion3 Jan 2018
  4. Study completion3 Jan 2019

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
Prospective
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03656055
Sponsor's protocol ID
2016_32
Other IDs
2017-A00194-49
Acronym
VWIMS
Status last verified
Aug 2018
First submitted
27 Aug 2018
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25149294

  • 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.

    PubMed 26227005

  • 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.

    PubMed 24114885

  • 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.

    PubMed 22300877

  • 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.

    PubMed 28920886

  • 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.

    PubMed 27011339

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by University Hospital, Lille at 1 site in France.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Sep 2022. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Study of asymptomatic retinal atrophy in multiple sclerosis and asymptomatic optic nerve demyelinating lesion (time frame: Day 1 (cross-sectional study)). 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 NCT03656055, 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 21 Sep 2022.

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