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NCT04289909

Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS)

Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

View on ClinicalTrials.gov

Summary

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.

Official title: Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-12-01

Completion Date

2024-07-17

Last Updated

2026-04-27

Healthy Volunteers

Yes

Conditions

Relapsing Remitting Multiple Sclerosis Progressive Multiple Sclerosis Optic Neuritis Eye Diseases Optic Nerve Diseases Nervous System Diseases Multiple Sclerosis

Interventions

OTHER

Adaptive Optics Ophthalmoscopy (AOO)

AOO will permit to detect and quantify retinal perivascular inflammation in patients with MS in comparison to Healthy volunteers (control group)

Inclusion Criteria: Group 1: * Age between 18 and 60 years old. * Relapsing remitting MS (criteria of McDonald 2017) * Less than 10 years of disease duration * Subject who has never presented a clinical episode of optic neuritis * Affiliation to a social security scheme or beneficiary of such a scheme Group 2: * Age between 18 and 60 years old * Relapsing remitting MS (criteria of McDonald 2017) * Less than 10 years of disease duration * Subject presenting an acute episode of retrobulbar optic neuritis within 3 months from onset * After optimal treatment for the retrobulbar optic neuritis * Affiliation to a social security scheme or beneficiary of such a scheme Group 3: * Age between 18 and 60 years old * Primary or Secondary progressive multiple sclerosis within 10 years of progressive phase; * Affiliation to a social security scheme or beneficiary of such a scheme Group 4 (Healthy Subjects): * Age between 18 and 60 years old * Affiliation to a social security scheme or beneficiary of such a scheme Exclusion Criteria: For all patients (Group 1; 2; 3): * Corticosteroid treatment within one month from inclusion * Other neurological, ophthalmologic or systemic disease; * Severe symptoms of uncontrolled chronic disease (renal, hepatic, hematologic, gastro-intestinal, pulmonary or cardiac or any intercurrent uncontrolled disease at inclusion) * Severe renal dysfunction (glomerular filtration rate \< 30mL/min). This non-inclusion criteria will be verified by serum creatinine test within six months from inclusion; * Contraindication for MRI; * Pregnancy or breast-feeding; * Unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly) * Incapacity to understand or sign the consent form; * Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty. For healthy subjects (Group 4): * Neurological, ophthalmologic or systemic disease; * Severe symptoms of uncontrolled chronic disease (renal, hepatic, hematologic, gastro-intestinal, pulmonary or cardiac or any intercurrent uncontrolled disease at inclusion); * Contraindication for MRI; * Pregnancy or breast-feeding; * Unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly) * Incapacity to understand or sign the consent form; * Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.

Locations (1)

Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere

Paris, France