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Linking Optic Nerve MRI and the Retinal Axonal Loss After Optic Neuritis (IRMANO)

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ClinicalTrials.gov Identifier: NCT03651362
Recruitment Status : Unknown
Verified August 2018 by University Hospital, Lille.
Recruitment status was:  Recruiting
First Posted : August 29, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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.

Condition or disease
Optic Neuritis

Detailed Description:

Neurologists and Neuro-Ophthalmologists are in need for reliable and robust imaging biomarkers enabling to predict retinal axonal loss and visual disability after clinical episode of optic neuritis (ON). Length of optic nerve lesion measured on MRI may be one of them.

The aim of our study is to measure the association between the extent of inflammatory demyelinating process on optic nerve at the acute of ON and the retinal degenerative process following optic nerve injury.

The investigators planned to include 50 patients suffering from a recent clinical episode of ON.

Extent of demyelinating inflammatory process will be assessed by the length of optic nerve double inversion recovery (DIR) hypersignal at the acute phase of ON.

The axonal degenerative process following optic nerve demyelinating injury will be assessed by retinal atrophy measured on optical coherence tomography at 12 months after ON, by visual disability measured on low vision contrast acuity scale and by microstructural quality analysis of optic nerve measured on diffusion tensor imaging sequence of the optic nerve.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Linking Optic Nerve Lesion Length at MRI and the Retinal Axonal Loss at 12 Months From a Clinical Episode of Optic Neuritis
Actual Study Start Date : February 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Severity of retinal axonal loss around papilla after a clinical episode of optic neuritis [ Time Frame: 12 months ]
    peripapillary RNFL thickness decrease


Secondary Outcome Measures :
  1. Severity of retinal axonal loss within macula after a clinical episode of optic neuritis [ Time Frame: 12 months ]
    macular volume decrease

  2. Severity of visual disability after a clinical episode of optic neuritis [ Time Frame: 12 months ]
    monocular low contrast (2.5%) vision

  3. Severity of microstructural architecture of optic nerve after a clinical episode of optic neuritis [ Time Frame: 12 months ]
    fractional anisotropy

  4. Progression of optic nerve lesion length [ Time Frame: 12 months ]
    lesion length in mm measured on 3D-double inversion recovery sequence


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • patient suffering from an acute clinical episode of optic neuritis (ON) confirmed by neurophthalmological examination
  • < 2 months between start of acute episode of ON and inclusion

Exclusion Criteria:

  • past history of homolateral episode of ON
  • retinal diseases
  • diabeta mellitus
  • pregnancy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651362


Contacts
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Contact: Olivier Outteryck, MD, PhD olivier.outteryck@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHRU de Lille Recruiting
Lille, France
Principal Investigator: Olivier Outteryck, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Olivier Outteryck, MD, PhD University Hospital, Lille
More Information
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Publications:

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03651362    
Other Study ID Numbers: 2015_26
2015-A01159-40 ( Other Identifier: ID-RCB number, ANSM )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
optic neuritis
DIR
visual disability
 CIS
multiple sclerosis
NMOSD
Additional relevant MeSH terms:
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Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases