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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
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
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

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 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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
MS patients
RRMS Patients with optic neuritis, RRMS patients without optic neuritis or Progressive MS patients
 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
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. parenchymal T2 lesion volume at MRI [ Time Frame: Baseline ]
    Evolution of MRI metrics: parenchymal T2 lesion volume

  8. gadolinium enhanced T1 lesion at MRI [ Time Frame: Baseline ]
    Evolution of MRI metrics: gadolinium enhanced T1 lesion

  9. optic nerve cross-sectional area at MRI [ Time Frame: Baseline ]
    Evolution of MRI metrics: optic nerve cross-sectional area

  10. Hyperintensity on the optic nerve at MRI [ Time Frame: Baseline ]
    Evolution of MRI metrics: Hyperintensity on the optic nerve


Eligibility Criteria
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Information from the National Library of Medicine

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

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Céline Louapre + 33 1 42 16 57 66 celine.louapre@aphp.fr

Locations
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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         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Biogen
Investigators
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Principal Investigator: Celine Louapre, MD, PHD Institut du Cerveau et de la Moelle Epinière
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
relapsing remitting Multiple sclerosis
Progressive Multiple Sclerosis
Optic neuritis
multiple sclerosis
 adaptive optics
eye disease
peripheral nervous system disease
Additional relevant MeSH terms:
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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