Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS) (RETIMUS)
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ClinicalTrials.gov Identifier: NCT04289909 |
Recruitment Status : Unknown
Verified February 2020 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Not yet recruiting
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
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Condition or disease | Intervention/treatment | Phase |
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Relapsing Remitting Multiple Sclerosis Progressive Multiple Sclerosis Optic Neuritis Eye Diseases Optic Nerve Diseases Nervous System Diseases Multiple Sclerosis | Other: Adaptive Optics Ophthalmoscopy (AOO) | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics |
Estimated Study Start Date : | March 2020 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 2022 |

Arm | Intervention/treatment |
---|---|
MS patients
RRMS Patients with optic neuritis, RRMS patients without optic neuritis or Progressive MS patients
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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) |
Control group
Healthy volunteers
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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) |
- Quantification of retinal perivascular cuff width across MS phenotypes [ Time Frame: Baseline ]The primary endpoint is to quantify retinal perivascular cuff width across MS phenotypes, compared among a group of control at baseline.
- Variation of size of perivascular sheathing [ Time Frame: month 3 and month 6 ]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
- Clinical disability measure with EDSS [ Time Frame: month 3 and month 6 ]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
- Clinical disability measured with MSFC [ Time Frame: month 3 and month 6 ]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
- Number of relapses [ Time Frame: month 3 and month 6 ]Evolution of Clinical disability: number of relapses at month 3 for MS patients with optic neuritis and at month 6 for all MS patients
- Presence of disc oedema measured at Optical Coherence Tomography (OCT) measurements [ Time Frame: month 3 and month 6 ]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
- RNLF thickness measured at Optical Coherence Tomography (OCT) measurements [ Time Frame: month 3 and month 6 ]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
- parenchymal T2 lesion volume at MRI [ Time Frame: Baseline ]Evolution of MRI metrics: parenchymal T2 lesion volume
- gadolinium enhanced T1 lesion at MRI [ Time Frame: Baseline ]Evolution of MRI metrics: gadolinium enhanced T1 lesion
- optic nerve cross-sectional area at MRI [ Time Frame: Baseline ]Evolution of MRI metrics: optic nerve cross-sectional area
- Hyperintensity on the optic nerve at MRI [ Time Frame: Baseline ]Evolution of MRI metrics: Hyperintensity on the optic nerve

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289909
Contact: Céline Louapre | + 33 1 42 16 57 66 | celine.louapre@aphp.fr |
France | |
Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere | |
Paris, France | |
Contact: Céline Louapre, MD, PH | |
Sub-Investigator: Michel Paques, PU, PH |
Principal Investigator: | Celine Louapre, MD, PHD | Institut du Cerveau et de la Moelle Epinière |
Responsible Party: | Institut National de la Santé Et de la Recherche Médicale, France |
ClinicalTrials.gov Identifier: | NCT04289909 |
Other Study ID Numbers: |
19-25 |
First Posted: | February 28, 2020 Key Record Dates |
Last Update Posted: | February 28, 2020 |
Last Verified: | February 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
relapsing remitting Multiple sclerosis Progressive Multiple Sclerosis Optic neuritis multiple sclerosis |
adaptive optics eye disease peripheral nervous system disease |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Multiple Sclerosis, Chronic Progressive Neuritis Optic Neuritis Optic Nerve Diseases Eye Diseases Sclerosis Inflammation |
Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Demyelinating Diseases Autoimmune Diseases Immune System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Cranial Nerve Diseases |