An observational study in Optic Neuritis, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by University Hospital, Lille · Observational
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…).
88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 25 observational studies indexed under Optic Neuritis.
Browse Optic Neuritis studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A history of pre-existing CNS inflammatory demyelinating disease is not a criterion for non-inclusion.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients suffering from an acute episode of optic neuritis will be included. There will be only one group of patients prospectively followed-up.
Other: Clinical examen
MRI sequences for research, pupillometry, OCT-angiography, evaluation of visual cognition
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
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
Started Oct 2022 (actual). Primary completion is estimated for Apr 2027, 54 months after the start.
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