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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04289909
Other study ID # 19-25
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2020
Est. completion date October 2022

Study information

Verified date February 2020
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Céline Louapre
Phone + 33 1 42 16 57 66
Email celine.louapre@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date October 2022
Est. primary completion date October 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
France Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere Paris

Sponsors (2)

Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France Biogen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Clinical disability measure with EDSS 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary parenchymal T2 lesion volume at MRI Evolution of MRI metrics: parenchymal T2 lesion volume Baseline
Secondary gadolinium enhanced T1 lesion at MRI Evolution of MRI metrics: gadolinium enhanced T1 lesion Baseline
Secondary optic nerve cross-sectional area at MRI Evolution of MRI metrics: optic nerve cross-sectional area Baseline
Secondary Hyperintensity on the optic nerve at MRI Evolution of MRI metrics: Hyperintensity on the optic nerve Baseline
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