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

NCT04289909 | Completed

• 1 other identifier: C19-25
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

relapsing remitting Multiple sclerosis; Progressive Multiple Sclerosis; Optic neuritis; multiple sclerosis; adaptive optics; eye disease; peripheral nervous system disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

Study Arms (2)

MS patients

OTHER

RRMS Patients with optic neuritis, RRMS patients without optic neuritis or Progressive MS patients

Other: Adaptive Optics Ophthalmoscopy (AOO)

Control group

OTHER

Healthy volunteers

Other: Adaptive Optics Ophthalmoscopy (AOO)

Interventions

Adaptive Optics Ophthalmoscopy (AOO) OTHER

AOO will permit to detect and quantify retinal perivascular inflammation in patients with MS in comparison to Healthy volunteers (control group)

Control group; MS patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• For all patients (Group 1; 2; 3):
• Other neurological, ophthalmologic or systemic disease;
• 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;
• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Biogen: collaborator

Study Sites (1)

Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere

Paris, France

Location

Related Publications (1)

• Gofas-Salas E, Mossad M, Beigneux Y, Norberg N, Castro Farias D, Vignal C, Paques M, Louapre C, Grieve K. In vivo characterization of a retinal cellular biomarker of inflammation in multiple sclerosis. Brain Commun. 2025 Nov 28;8(1):fcaf471. doi: 10.1093/braincomms/fcaf471. eCollection 2026.

  PMID: 41788164 RESULT

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Optic Neuritis; Eye Diseases; Optic Nerve Diseases; Nervous System Diseases; Multiple Sclerosis; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cranial Nerve Diseases; Neuromuscular Diseases

Study Officials

• Celine Louapre, MD, PHD

  Institut du Cerveau et de la Moelle Epinière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: December 1, 2020
• Primary Completion: June 26, 2024
• Study Completion: July 17, 2024
• Last Updated: April 27, 2026

Record last verified: 2025-04

Locations

FR (1)