Relapsing Remitting Multiple SclerosisRETIMUSNCT04289909
Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS)
A study testing Adaptive Optics Ophthalmoscopy (AOO) in people with Relapsing Remitting Multiple Sclerosis and Progressive Multiple Sclerosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Optic Neuritis
- What is being tested?
- Adaptive Optics Ophthalmoscopy (AOO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere
Paris
About this study
Official title: Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics
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.
Read the 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
- Being tested
- Adaptive Optics Ophthalmoscopy (AOO)
- Keywords
- relapsing remitting Multiple sclerosis, Progressive Multiple Sclerosis, Optic neuritis, multiple sclerosis, adaptive optics, eye disease, peripheral nervous system disease
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive, Optic Neuritis, Eye Diseases, Optic Nerve Diseases, Nervous System Diseases, Multiple Sclerosis, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| MS patients | Other | RRMS Patients with optic neuritis, RRMS patients without optic neuritis or Progressive MS patients Receives: Other: Adaptive Optics Ophthalmoscopy (AOO) |
| Control group | Other | Healthy volunteers Receives: Other: Adaptive Optics Ophthalmoscopy (AOO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (10)
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
Measured: month 3 and month 6
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
Measured: month 3 and month 6
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
Measured: month 3 and month 6
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
Measured: month 3 and month 6
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
Measured: month 3 and month 6
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
Measured: month 3 and month 6
parenchymal T2 lesion volume at MRI
Evolution of MRI metrics: parenchymal T2 lesion volume
Measured: Baseline
gadolinium enhanced T1 lesion at MRI
Evolution of MRI metrics: gadolinium enhanced T1 lesion
Measured: Baseline
optic nerve cross-sectional area at MRI
Evolution of MRI metrics: optic nerve cross-sectional area
Measured: Baseline
Hyperintensity on the optic nerve at MRI
Evolution of MRI metrics: Hyperintensity on the optic nerve
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Dec 2020
- Primary completion26 Jun 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Celine Louapre, MD, PHD, Principal investigator, Paris Brain Institute (ICM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289909
- Sponsor's protocol ID
- C19-25
- Acronym
- RETIMUS
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41788164
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics
- ClinicalTrials.gov ID
- NCT04289909
- Acronym / sponsor ID
- RETIMUS / C19-25
- Conditions
- Relapsing Remitting Multiple Sclerosis, Progressive Multiple Sclerosis, Optic Neuritis, Eye Diseases, Optic Nerve Diseases, Nervous System Diseases
- Keywords
- relapsing remitting Multiple sclerosis, Progressive Multiple Sclerosis, Optic neuritis, multiple sclerosis, adaptive optics, eye disease, peripheral nervous system disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Biogen
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS patients | Other | Other: Adaptive Optics Ophthalmoscopy (AOO)RRMS Patients with optic neuritis, RRMS patients without optic neuritis or Progressive MS patients |
| Control group | Other | Other: Adaptive Optics Ophthalmoscopy (AOO)Healthy volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Control group, MS patients |
Primary outcome
Quantification of retinal perivascular cuff width across MS phenotypes
Time frame: Baseline
The primary endpoint is to quantify retinal perivascular cuff width across MS phenotypes, compared among a group of control at baseline.
10 secondary outcomes
Variation of size of perivascular sheathing
Time frame: month 3 and month 6
Clinical disability measure with EDSS
Time frame: month 3 and month 6
Clinical disability measured with MSFC
Time frame: month 3 and month 6
Number of relapses
Time frame: month 3 and month 6
Presence of disc oedema measured at Optical Coherence Tomography (OCT) measurements
Time frame: month 3 and month 6
RNLF thickness measured at Optical Coherence Tomography (OCT) measurements
Time frame: month 3 and month 6
parenchymal T2 lesion volume at MRI
Time frame: Baseline
gadolinium enhanced T1 lesion at MRI
Time frame: Baseline
optic nerve cross-sectional area at MRI
Time frame: Baseline
Hyperintensity on the optic nerve at MRI
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Results publication: PubMed 41788164Gofas-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.
Related trials for Relapsing Remitting Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celine Louapre, MD, PHD principal investigator
Paris Brain Institute (ICM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Optics Ophthalmoscopy (AOO) in people with Relapsing Remitting Multiple Sclerosis and Progressive Multiple Sclerosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of retinal perivascular cuff width across MS phenotypes (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04289909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.