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CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS

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ClinicalTrials.gov Identifier: NCT02543788
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Fondation pour la Recherche Médicale
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Patients with multiple sclerosis (MS) may show chronic signs of optic neuropathy (CON) that may follow acute optic neuritis (secondary form of CON, S-CON) or occur independently of any acute demyelinating lesion of the optic nerve (primary form of CON, P-CON). In both S-CON and P-CON, a long term progressive ganglion cell axonal loss occurs. This axonal damage could be secondary to retrograde atrophy of axons within plaques of demyelination or a primary progressive degeneration of ganglion cells, but the underlying physiopathology has not been fully questioned in the different profile types of CON.

In this project, investigators aim at understanding the pathophysiology of S-CON and P-CON, i.e. secondary to demyelination or primary degeneration, in patients complaining of persistent visual complaints. In a first cross sectional study, 30 MS patients with mild to moderate P-CPON or S-CON and 30 age-matched control subjects will perform an extensive neuro-ophthalmological assessment including clinical examination, visual evoked potentials (pattern and low contrast), electroretinogram (pattern and multifocal ERG), OCT (peripapillary and macular volume scan segmentation protocols) and MRI of the optic nerve. In these patients with mild to moderate CON, investigators aim at differentiating patients showing predominant demyelination from those showing pure or predominant axonal degeneration. Visual function assessment and degree of axonal degeneration will be compared and correlated in the two types of underlying pathophysiology and in the group of control subject. In a following longitudinal study, the patients will be re-assessed a year later in order to evaluate the progression of CON in both profile types. Our hypothesis would be that visual function and progression is worse in the degeneration group as compared to the demyelination group. This study should help to find reliable measures of the pathophysiology of CON and correlate it with the long-term visual prognostic of the disease.


Condition or disease Intervention/treatment Phase
Chronic Optic Neuropathy in Multiple Sclerosis Procedure: • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS: DEMYELINATING AND/OR PRIMARY DEGENERATIVE PATHOPHYSIOLOGY?
Actual Study Start Date : September 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
patients
patients with chronic optic neuropathy in multiple sclerosis
 Procedure: • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG
Controls
healthy volunteers
 Procedure: • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG


Outcome Measures
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Primary Outcome Measures :
  1. Change from Day0 15' P100 VEP latency at one year [ Time Frame: D0 and one year ]
    15' VEP latency may be the best outcome that allow differentiating patients from controls, and each of the sub-group of patients


Secondary Outcome Measures :
  1. Change from Day0 100%, 2.5% and 1.25% ETDRS Visual Acuity at one year (composite measure) [ Time Frame: D0 and one year ]
  2. Change from Day0 Visual field macular threshold and corrected mean visual field deficit at one year (composite measure) [ Time Frame: D0 and one year ]
  3. change frome Day0 NEI-VFQ 25 composite score and 10-item score at one year (composite measure) [ Time Frame: D0 and one year ]
  4. Change from Day0 N75, P100, N135 VEP latency and amplitude; P50, N95 ERG latency and amplitude; p1 mERG latency and amplitude at one year (composite measure) [ Time Frame: D0 and one year ]
  5. Change from Day0 OCT peripapillary RNLF thickness and Ganglion cell layer average thickness on macular dense volume at one year (composite measure) [ Time Frame: D0 and one year ]
  6. MRI presence or absence of optic nerve inflammatory signs on diameter of the optic nerve [ Time Frame: D0 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria for patients

    • All patients may have a clinically definite, laboratory-supported diagnosis of multiple sclerosis according to the Mac Donald criteria (2010).
    • All patients may present a chronic visual complaint.
    • All patients may present mild to moderate chronic optic neuropathy (cf infra)
    • All patients may not have recent acute optic neuritis (<2 years)
    • All patients will be informed about the design and purpose of the study, and all will give their informed, written consent to the protocol, which may have been approved by the local ethics committee.
    • Age: > 18
    • Able to understand the instructions
    • Having a health coverage
    • Able to sit down for 1 hour Diagnosis of mild to moderate chronic optic neuropathy

For the diagnosis of optic neuropathy, patients will have to meet 3 of the 6 next criteria:

  1. Far Visual Acuity (ETDRS charts, 100% contrast) < 85 letters
  2. Far Visual Acuity (ETDRS charts, 2.5% contrast) < 60 letters
  3. Mean visual field defect on static perimetry> 2dB
  4. Mean pRNFL in OCT < 80 µ.
  5. Color vision score > 35

  6. Disc pallor Diagnosis of mild to moderate optic neuropathy

    • Far Visual Acuity (ETDRS charts, 100% contrast) >70 letters Diagnosis of chronic optic neuropathy

    • Stable or worsening of visual acuity, visual field and/or RNFL in OCT, at 6 month of interval

      - Inclusion criteria for controls

    • Age > 18 years
    • Visual acuity score (ETDRS) > 85
    • Able to understand the instructions
    • Having a health coverage
    • Informed and consenting to give his written consent

Exclusion Criteria:

  • Non inclusion criteria for patients.

    • Ophthalmological

      • Other ophthalmological disorder that could impair corrected visual acuity (Maculopathy, Retinopathy…)
      • Ocular instability in primary position of gaze

    • Neurological

      • Ongoing seizure
      • Severe handicap that does not allow sitting down position for 1 hour

    • General

      • Unstable medical state
      • Severe renal insufficiency
      • Allergy to gadolinium
      • Claustrophobia
      • Implanted electrical stimulator (pace maker)
      • Metallic prosthesis or orthesis, cochlear implants
      • Intraocular foreign material
    • Pregnancy (on questioning)
    • Tutelage or any legal protection measure

  • Non inclusion criteria for controls

    • Any ophthalmological disorder that could impair corrected visual acuity
    • Any neurological disorder
    • MRI contraindication
    • Allergy to gadolinium
    • Severe renal insufficiency
    • Claustrophobia
    • Implanted electrical stimulator (pace maker)
    • Metallic prosthesis or orthesis, cochlear implants
    • Intraocular foreign material
    • Pregnancy (on questioning)
    • Tutelage or any legal protection measure
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02543788


Locations
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France
Unité de Neuro-Ophtalmologie - Hôpital Neurologique - HOSPICES CIVILS DE LYON
France, Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Fondation pour la Recherche Médicale
Investigators
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Principal Investigator: Caroline TILIKETE, MD Unité de Neuro-Ophtalmologie - Hôpital Neurologique - HOSPICES CIVILS DE LYON - France
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02543788    
Other Study ID Numbers: 2014.850
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by Hospices Civils de Lyon:
optic neuritis
vision
quality of life
pathophysiology
Additional relevant MeSH terms:
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Multiple Sclerosis
Optic Nerve Diseases
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cranial Nerve Diseases
Eye Diseases