Optic NeuritisVIP-MODELNCT05487989
VIsual Pathways Model in Neuro-inflammatory Disorders
An observational study of Optic Neuritis, run by University Hospital, Lille at 1 site in France.
Trial summary
In neuroinflammatory diseases of the central nervous system (CNS) such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and anti-MOG antibody-associated disorders (MOGAD), neuronal degeneration is the consequence of inflammatory and demyelinating lesions in the brain, optic nerve and spinal… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Clinical examen
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2022to 7 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients presenting an episode of acute optic neuritis with the objective of better understanding the pathophysiology of CNS inflammatory diseases and identifying prognostic biomarkers in imaging
Who may be able to join
- - Male or female
- Aged between 18 and 65 years
- Presenting a clinical picture of optic neuritis for less than 4 weeks, confirmed by neuro-ophthalmological assessment
- Patient having given written consent to participate in the study
- Patient with social insurance
- Patient willing to comply with all study procedures and duration
Who cannot join
- - history of optic neuritis on the same side as the recent episode for which the patient is being treated
- history of retinal pathology (retinal detachment, glaucoma, retinopathies, retinal surgery)
- diabetes
- chronic alcohol intoxication
- contraindications to MRI
- pregnant women
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- persons under protective supervision (ex : guardianship)
- minors
- persons deprived of their liberty
- administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent
- A history of pre-existing CNS inflammatory demyelinating disease is not a criterion for non-inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of the VIsual Pathways MODEL for a Better Understanding of Neurodegeneration in Inflammatory and Demyelinating Disorders of Central Nervous System
In neuroinflammatory diseases of the central nervous system (CNS) such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and anti-MOG antibody-associated disorders (MOGAD), neuronal degeneration is the consequence of inflammatory and demyelinating lesions in the brain, optic nerve and spinal cord. Both white and grey matter are systematically affected. Lesions of the perivascular spaces containing cerebrospinal fluid (CSF) and meningeal inflammation seem to play an important role in the pathophysiology of these neuroinflammatory diseases. Currently, the interrelation of all these aspects is not clearly established in the pathophysiology of these diseases. In order to better understand the mechanisms that lead to and underlie the clinical disability of patients with these diseases, we need in vivo study models that allow the in-depth study of the neurodegenerative process and the identification of its causes. In this perspective, we make the hypothesis that the visual pathways model is very relevant to measure neuro-axonal loss and to explore the different mechanisms involved in neurodegeneration during MS and other CNS demyelinating diseases. Researchers have at their disposal many tools that allow them to analyse and quantify the neurodegenerative process in a reproducible and very precise manner from a structural and functional point of view, while taking into account possible vascular involvement (MRI, optical coherence tomography - angiography, etc…).
- Conditions
- Optic Neuritis
- Being tested
- Clinical examen
- Keywords
- Optic neuritis, Optical coherence tomography, MRI, demyelination, neuro-axonal loss., MRI, demyelination, neuro-axonal loss
- Medical subject headings
- Optic Neuritis, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examenOther
MRI sequences for research, pupillometry, OCT-angiography, evaluation of visual cognition
| Study group | Role | What they receive |
|---|---|---|
| optic neuritis patients | Patients suffering from an acute episode of optic neuritis will be included. There will be only one group of patients prospectively followed-up. Receives: Other: Clinical examen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of enhancement of the optic nerve sheath on the axial T1 dixon MRI sequence post gadolinium at the acute phase of optic neuritis.
Measured: at inclusion
Low contrast monocular visual acuity (2.5%, LogMAR unit) at distance from acute optic neuritis
Measured: at 12 months
Secondary outcomes (10)
Presence of enhancement of the optic nerve sheath on the axial T1 dixon MRI sequence post gadolinium. Macular GCIPL atrophy will be assessed by the variation of mGCIPL volume between inclusion and the maximal follow-up.
Measured: at inclusion and at 12 months follow-up
Optic nerve lesion length on 3D-DIR sequence. Alteration of retinal microvascularisation between inclusion and the maximal follow-up.
Measured: at inclusion and at 12 months follow-up
Acute alteration of retinal microvascularisation is assessed by the difference of retinal vascular density between inclusion (V0) and one month later (V1).
Measured: at inclusion and at 1 months follow-up
Low contrast monocular visual acuity (2.5%, LogMAR unit) measured at 12 months (V5)
Measured: at inclusion and at 12 months follow-up
Amplitude of the melanopsin-mediated sustained constriction phase in the blue light-induced pupillary response is assessed at 12 months (V5).
Measured: at inclusion and at 12 months follow-up
Optic nerve lesion length assessed at inclusion (V0)
Measured: at inclusion
mGCIPL atrophy/retinal vascular alteration are assessed by mGCIPL volume/retinal vessel density difference between inclusion (V0) and at 12 months (V5).
Measured: at inclusion and at 12 months follow-up
Presence of leptomeningeal cerebral enhancement
Measured: at inclusion, at 6 months and at 12 months follow-up
T2 lesions brain and spinal cord volumes
Measured: at inclusion, at 6 months and at 12 months follow-up
Brain grey matter volumes and brain perfusion (3D-ASL)
Measured: at inclusion, at 6 months and at 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start7 Oct 2022
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier OUTTERYCK, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487989
- Sponsor's protocol ID
- 2022_0289
- Other IDs
- 2022-A01483-40
- Acronym
- VIP-MODEL
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2022
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the VIsual Pathways MODEL for a Better Understanding of Neurodegeneration in Inflammatory and Demyelinating Disorders of Central Nervous System
- ClinicalTrials.gov ID
- NCT05487989
- Acronym / sponsor ID
- VIP-MODEL / 2022_0289
- Conditions
- Optic Neuritis
- Keywords
- Optic neuritis, Optical coherence tomography, MRI, demyelination, neuro-axonal loss., MRI, demyelination, neuro-axonal loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Apr 2028 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In neuroinflammatory diseases of the central nervous system (CNS) such as multiple sclerosis (MS), neuromyelitis optica spectrum disorders (NMOSD) and anti-MOG antibody-associated disorders (MOGAD), neuronal degeneration is the consequence of inflammatory and demyelinating lesions in the brain, optic nerve and spinal cord. Both white and grey matter are systematically affected. Lesions of the perivascular spaces containing cerebrospinal fluid (CSF) and meningeal inflammation seem to play an important role in the pathophysiology of these neuroinflammatory diseases. Currently, the interrelation of all these aspects is not clearly established in the pathophysiology of these diseases. In order to better understand the mechanisms that lead to and underlie the clinical disability of patients with these diseases, we need in vivo study models that allow the in-depth study of the neurodegenerative process and the identification of its causes. In this perspective, we make the hypothesis that the visual pathways model is very relevant to measure neuro-axonal loss and to explore the different mechanisms involved in neurodegeneration during MS and other CNS demyelinating diseases. Researchers have at their disposal many tools that allow them to analyse and quantify the neurodegenerative process in a reproducible and very precise manner from a structural and functional point of view, while taking into account possible vascular involvement (MRI, optical coherence tomography - angiography, etc…).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| optic neuritis patients | – | Other: Clinical examenPatients suffering from an acute episode of optic neuritis will be included. There will be only one group of patients prospectively followed-up. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting an episode of acute optic neuritis with the objective of better understanding the pathophysiology of CNS inflammatory diseases and identifying prognostic biomarkers in imaging
Key inclusion criteria (6 listed)
- - Male or female
- Aged between 18 and 65 years
- Presenting a clinical picture of optic neuritis for less than 4 weeks, confirmed by neuro-ophthalmological assessment
- Patient having given written consent to participate in the study
- Patient with social insurance
Key exclusion criteria (11 listed)
- - history of optic neuritis on the same side as the recent episode for which the patient is being treated
- history of retinal pathology (retinal detachment, glaucoma, retinopathies, retinal surgery)
- diabetes
- chronic alcohol intoxication
- contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examenMRI sequences for research, pupillometry, OCT-angiography, evaluation of visual cognition | Other | optic neuritis patients |
Primary outcome
Presence of enhancement of the optic nerve sheath on the axial T1 dixon MRI sequence post gadolinium at the acute phase of optic neuritis.
Time frame: at inclusion
Low contrast monocular visual acuity (2.5%, LogMAR unit) at distance from acute optic neuritis
Time frame: at 12 months
10 secondary outcomes
Presence of enhancement of the optic nerve sheath on the axial T1 dixon MRI sequence post gadolinium. Macular GCIPL atrophy will be assessed by the variation of mGCIPL volume between inclusion and the maximal follow-up.
Time frame: at inclusion and at 12 months follow-up
Optic nerve lesion length on 3D-DIR sequence. Alteration of retinal microvascularisation between inclusion and the maximal follow-up.
Time frame: at inclusion and at 12 months follow-up
Acute alteration of retinal microvascularisation is assessed by the difference of retinal vascular density between inclusion (V0) and one month later (V1).
Time frame: at inclusion and at 1 months follow-up
Low contrast monocular visual acuity (2.5%, LogMAR unit) measured at 12 months (V5)
Time frame: at inclusion and at 12 months follow-up
Amplitude of the melanopsin-mediated sustained constriction phase in the blue light-induced pupillary response is assessed at 12 months (V5).
Time frame: at inclusion and at 12 months follow-up
Optic nerve lesion length assessed at inclusion (V0)
Time frame: at inclusion
mGCIPL atrophy/retinal vascular alteration are assessed by mGCIPL volume/retinal vessel density difference between inclusion (V0) and at 12 months (V5).
Time frame: at inclusion and at 12 months follow-up
Presence of leptomeningeal cerebral enhancement
Time frame: at inclusion, at 6 months and at 12 months follow-up
T2 lesions brain and spinal cord volumes
Time frame: at inclusion, at 6 months and at 12 months follow-up
Brain grey matter volumes and brain perfusion (3D-ASL)
Time frame: at inclusion, at 6 months and at 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier OUTTERYCK, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Neuritis, 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 20 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier OUTTERYCK, MD (0320445962 ext. +33, olivier.outteryck@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of enhancement of the optic nerve sheath on the axial T1 dixon MRI sequence post gadolinium at the acute phase of optic neuritis. (time frame: at inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.