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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
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Using a technique called adaptive optics imaging applied on retina, investigators aim to gain access to vascular changes that could occur early in the course of Multiple Sclerosis (MS) and which could reflect vascular changes occurring along the optic nerve of the brain parenchyma. Indeed, our team has been able to develop a quantitative method to measure the perivascular infiltrate in the retina of patients with various inflammatory retinal disease. It has been observed in MS patients that this perivascular infiltrate can also be detected in the retina. However, its distribution across MS phenotypes (relapsing or progressive MS, with and without optic neuritis) is still unknown.
This is a monocentric pathophysiological, interventional, prospective, open label, non-randomized pilot study which aims to identify in patients with MS at different stages if the presence of retinal perivascular inflammation can be detected and quantified using adaptive optics, which is a non-invasive examination.
Investigators will recruit MS patients in 3 subgroups, depending on their phenotype (Relapsing Remitting Multiple Sclerosis (RRMS) without optic neuritis, RRMS with optic neuritis, progressive MS), with 15 patients in each group.
15 healthy volunteers (HV) will also be enrolled.
The comparison of these groups is necessary to determine if there are significant differences, allowing us to highlight biomarkers in MS patients in order to enable highly efficient and robust trials designs in the future.
To test the hypothesis, the study has 3 visits over 6 months (M0, M3 and M6). Neurological evaluation, blood sample, imaging, ophthalmologic evaluation and Adaptive optics ophthalmoscopy assessments will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS patients | Other | RRMS Patients with optic neuritis, RRMS patients without optic neuritis or Progressive MS patients |
|
| Control group | Other | Healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Optics Ophthalmoscopy (AOO) | Other | AOO will permit to detect and quantify retinal perivascular inflammation in patients with MS in comparison to Healthy volunteers (control group) |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of retinal perivascular cuff width across MS phenotypes | The primary endpoint is to quantify retinal perivascular cuff width across MS phenotypes, compared among a group of control at baseline. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of size of perivascular sheathing | Variation of size of perivascular sheathing along retinal vessels in the posterior pole during follow up (at month 3 and month 6) in patients with MS and a group of control | month 3 and month 6 |
| Clinical disability measure with EDSS |
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Inclusion Criteria:
Group 1:
Group 2:
Group 3:
Group 4 (Healthy Subjects):
Exclusion Criteria:
For all patients (Group 1; 2; 3):
For healthy subjects (Group 4):
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| Name | Affiliation | Role |
|---|---|---|
| Celine Louapre, MD, PHD | Paris Brain Institute (ICM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41788164 | Result | Gofas-Salas E, Mossad M, Beigneux Y, Norberg N, Castro Farias D, Vignal C, Paques M, Louapre C, Grieve K. In vivo characterization of a retinal cellular biomarker of inflammation in multiple sclerosis. Brain Commun. 2025 Nov 28;8(1):fcaf471. doi: 10.1093/braincomms/fcaf471. eCollection 2026. |
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Evolution of Clinical disability: Expanded Disability Status Scale (EDSS: 0: normal neurological exam; 10 : death of the patient) at month 3 for MS patients with optic neuritis and at month 6 for all MS patients |
| month 3 and month 6 |
| Clinical disability measured with MSFC | Evolution of Clinical disability: Multiple Sclerosis Functional Composite (MSFC) at month 3 for MS patients with optic neuritis and at month 6 for all MS patients | month 3 and month 6 |
| Number of relapses | Evolution of Clinical disability: number of relapses at month 3 for MS patients with optic neuritis and at month 6 for all MS patients | month 3 and month 6 |
| Presence of disc oedema measured at Optical Coherence Tomography (OCT) measurements | Evolution of OCT measurements (presence of disc oedema) at month 3 for MS patients with optic neuritis and at month 6 for all MS patients | month 3 and month 6 |
| RNLF thickness measured at Optical Coherence Tomography (OCT) measurements | Evolution of OCT measurements : retinal nerve fiber layer thickness (RNFL, µm) at month 3 for MS patients with optic neuritis and at month 6 for all MS patients | month 3 and month 6 |
| parenchymal T2 lesion volume at MRI | Evolution of MRI metrics: parenchymal T2 lesion volume | Baseline |
| gadolinium enhanced T1 lesion at MRI | Evolution of MRI metrics: gadolinium enhanced T1 lesion | Baseline |
| optic nerve cross-sectional area at MRI | Evolution of MRI metrics: optic nerve cross-sectional area | Baseline |
| Hyperintensity on the optic nerve at MRI | Evolution of MRI metrics: Hyperintensity on the optic nerve | Baseline |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D009902 | Optic Neuritis |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009103 | Multiple Sclerosis |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003389 | Cranial Nerve Diseases |
| D009468 | Neuromuscular Diseases |
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