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AzTrials

Chronic Optic Neuropathy in Multiple SclerosisNCT02543788

CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS

A study testing • 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 in people with Chronic Optic Neuropathy in Multiple Sclerosis, run by Hospices Civils de Lyon 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

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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
• 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
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteFrance
Study dates
Sep 2014to Aug 2016
Phase
Interventional
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Unité de Neuro-Ophtalmologie - Hôpital Neurologique - HOSPICES CIVILS DE LYON

    France, BRON, 69677

Other trials in France

About this study

Official title: CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS: DEMYELINATING AND/OR PRIMARY DEGENERATIVE PATHOPHYSIOLOGY?

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.

Being tested
• 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
Keywords
optic neuritis, vision, quality of life, pathophysiology
Medical subject headings
Optic Neuritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • • Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERGProcedure or surgery

Study groups in NCT02543788
Study groupRoleWhat they receive
patientsOtherpatients with chronic optic neuropathy in multiple sclerosis
Receives: 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
ControlsOtherhealthy volunteers
Receives: 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

What is being measured

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

  1. Change from Day0 15' P100 VEP latency at one year

    15' VEP latency may be the best outcome that allow differentiating patients from controls, and each of the sub-group of patients

    Measured: D0 and one year

Secondary outcomes (6)

  1. Change from Day0 100%, 2.5% and 1.25% ETDRS Visual Acuity at one year (composite measure)

    Measured: D0 and one year

  2. Change from Day0 Visual field macular threshold and corrected mean visual field deficit at one year (composite measure)

    Measured: D0 and one year

  3. change frome Day0 NEI-VFQ 25 composite score and 10-item score at one year (composite measure)

    Measured: 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)

    Measured: 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)

    Measured: D0 and one year

  6. MRI presence or absence of optic nerve inflammatory signs on diameter of the optic nerve

    Measured: D0

Timeline

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

  1. First posted7 Sep 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02543788
Sponsor's protocol ID
2014.850
Status last verified
Aug 2025
First submitted
25 Jun 2014
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
No

Publications

  • Physiopathologie de la Neuropathie Optique Chronique de la SEP " Lucie ABOUAF, François DURAND-DUBIEF, Sandra VUKUSIC, Alain VIGHETTO, Caroline TILIKETE. Communication orale aux 3e journée des Neurosciences de l'Hôpital Neurologique le jeudi 24 septembre 2015, Institut des Sciences Cognitives, Lyon.

Questions about this trial

What is this clinical trial studying?

A study testing • 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 in people with Chronic Optic Neuropathy in Multiple Sclerosis, run by Hospices Civils de Lyon 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 24 inclusion and 29 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 3 Sep 2025. 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?

Change from Day0 15' P100 VEP latency at one year (time frame: D0 and one year). 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 NCT02543788, which also lists 1 linked publication.

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 3 Sep 2025.

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