Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quantification of retinal perivascular cuff width across MS phenotypes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
MS patients
RRMS Patients with optic neuritis, RRMS patients without optic neuritis or Progressive MS patients
干预措施: Adaptive Optics Ophthalmoscopy (AOO) (Other)
Control group
Healthy volunteers
干预措施: Adaptive Optics Ophthalmoscopy (AOO) (Other)
结局指标
主要结局
Quantification of retinal perivascular cuff width across MS phenotypes
时间窗: Baseline
The primary endpoint is to quantify retinal perivascular cuff width across MS phenotypes, compared among a group of control at baseline.
次要结局
- Variation of size of perivascular sheathing(month 3 and month 6)
- Clinical disability measure with EDSS(month 3 and month 6)
- Clinical disability measured with MSFC(month 3 and month 6)
- Number of relapses(month 3 and month 6)
- Presence of disc oedema measured at Optical Coherence Tomography (OCT) measurements(month 3 and month 6)
- RNLF thickness measured at Optical Coherence Tomography (OCT) measurements(month 3 and month 6)
- parenchymal T2 lesion volume at MRI(Baseline)
- gadolinium enhanced T1 lesion at MRI(Baseline)
- optic nerve cross-sectional area at MRI(Baseline)
- Hyperintensity on the optic nerve at MRI(Baseline)