NCT04289909

Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS)

Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Relapsing Remitting Multiple Sclerosis
• Progressive Multiple Sclerosis
• Optic Neuritis
• Eye Diseases
• Optic Nerve Diseases
• Nervous System Diseases
• Multiple Sclerosis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-12-01
• Primary completion: 2024-06-26
• Completion: 2024-07-17
• First posted: 2020-02-28
• Last updated: 2025-04-04

Locations

1 site across 1 country: France