Status:
COMPLETED
Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS)
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
Biogen
Conditions:
Relapsing Remitting Multiple Sclerosis
Progressive Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04289909
Start Date
December 1 2020
End Date
July 17 2024
Last Update
April 4 2025
Active Locations (1)
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1
Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere
Paris, France