CompletedNot a drug-phase studyRelapsing and progressiveNCT04289909

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Adaptive Optics Ophthalmoscopy (AOO)

What it measured

Main measures

  • Quantification of retinal perivascular cuff width across MS phenotypes

    Baseline

Other measures (10)

  • Variation of size of perivascular sheathing

    month 3 and month 6

  • Clinical disability measure with EDSS

    month 3 and month 6

    Disability progression
  • Clinical disability measured with MSFC

    month 3 and month 6

    Disability progression
  • Number of relapses

    month 3 and month 6

    Relapses
  • Presence of disc oedema measured at Optical Coherence Tomography (OCT) measurements

    month 3 and month 6

    Retina scans (OCT)
  • RNLF thickness measured at Optical Coherence Tomography (OCT) measurements

    month 3 and month 6

    Retina scans (OCT)
  • parenchymal T2 lesion volume at MRI

    Baseline

    MRI lesions
  • gadolinium enhanced T1 lesion at MRI

    Baseline

    MRI lesions
  • optic nerve cross-sectional area at MRI

    Baseline

    MRI lesions
  • Hyperintensity on the optic nerve at MRI

    Baseline

    MRI lesions

Who could take part

Relapsing and progressive · 18 to 60

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Dec 2020

    2. Main results due

      Jun 2024

    3. Finished

      Jul 2024

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