Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Ada… (NCT04289909) | Clinical Trial Compass
CompletedNot Applicable
Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS)
France50 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 creat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of retinal perivascular cuff width across MS phenotypes
Timeframe: Baseline
Trial details
NCT IDNCT04289909
SponsorInstitut National de la Santé Et de la Recherche Médicale, France