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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Optic Neuritis Differential Diagnosis Study

Study Purpose

Background: Optic neuritis is a frequent cause of vision loss encountered by ophthalmologists in the Caribbean. The diagnosis is made on clinical grounds. Optic neuritis can occur either in an isolated manner or, most often, as the first symptom of multiple sclerosis (MS) or neuromyelitisoptica (NMO). These 2 demyelinating disorders differ by many means, including treatment and prognosis. MS can cause severe long-term disability while NMO is a short-term sight- and life-threatening condition causing potential relapses, which may require plasma exchanges. Furthermore, disease-modifying therapies used in NMO are different from those used in MS, which can worsen the natural history of NMO. Early differential diagnosis of these diseases is thus crucial for preventing severe visual loss and disability.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient aged 18 years or older at time of inclusion. 2. Table of unilateral or bilateral optic neuritis defined as follows (clinical diagnosis): 1. Visual sharpness (acuity and / or visual field) experienced acutely or subacutely (<1 month) unilateral or bilateral, not corrected by optical correction. 2. Absence of ophthalmologic lesion which may explain the visual loss. 3. Examination of the normal fundus or showing a pallor or papular edema. 4. Presence of relative pupillary deficit relative if unilateral attack. 3. Patient (s) affiliated to a social security scheme (beneficiary or beneficiary). 4. Patient who has given free and written consent.

Exclusion Criteria:

1. Patients known to have an inflammatory disease of the central nervous system (MS, NMO, EMAD). 2. Known history of inflammatory pathology (lupus or sarcoidosis) or infectious pathology (syphilis, HIV) that may give rise to optical neuropathy. 3. Table suggestive of Leber's hereditary optic neuropathy (genetically confirmed). 4. Treatment in progress known to give optical neuropathies. 5. Consumption of toxic known to give optical neuropathies. 6. Drinking more than 3 alcohol drinks per day for men and 2 alcohol drinks per day for women over a period of more than 15 years. 7. Arguments for non-arteritic ischemic optic neuropathy defined by all of the following criteria: 1. Absence of pain in eye movements. 2. Altitudinal deficit of the visual field. 3. Choroidal ischemia with fluorescein angiography. 4. Presence of cardiovascular risk factors. 5. Absence of neurological signs related to inflammatory disease of the central nervous system. 8. Arguments for arterial ischemic optic neuropathy defined by all of the following criteria: 1. Absence of pain in eye movements. 2. Altitudinal deficit of the visual field. 3. Choroidal ischemia with fluorescein angiography. 4. Presence of symptoms suggestive of Horton's disease. 5. Absence of neurological signs related to inflammatory disease of the central nervous system. 9. Pregnant and lactating patients.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03370965
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Center of Martinique
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Philippe CABRE, PhD
Principal Investigator Affiliation Centre Hospitalier Universitaire de Martinique
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Optic Neuritis, Neuromyelitis Optica, Multiple Sclerosis
Additional Details

Background: Optic neuritis is a frequent cause of vision loss encountered by ophthalmologists in the Caribbean. The diagnosis is made on clinical grounds. Optic neuritis can occur either in an isolated manner or, most often, as the first symptom of multiple sclerosis (MS) or neuromyelitisoptica (NMO). These 2 demyelinating disorders differ by many means, including treatment and prognosis. MS can cause severe long-term disability while NMO is a short-term sight- and life-threatening condition causing potential relapses, which may require plasma exchanges. Furthermore, disease-modifying therapies used in NMO are different from those used in MS, which can worsen the natural history of NMO. Early differential diagnosis of these diseases is thus crucial for preventing severe visual loss and disability. Purpose: The investigators aim to identify early predictive factors (clinical, biological and radiological) of NMO occurrence in patients presenting with optic neuritis and with no prior history of demyelinating diseases. Method: The investigators will conduct a multicentric prospective study including all patients of 18 years or older, with no prior history of demyelinating disorders and presenting with a diagnosis of optic neuritis in Martinique, Guadeloupe, French Guiana, Saint-Martin and Saint-Barthélemy. Patients will first undergo a full neuro-ophthalmic examination which includes visual acuity, contrast vision, color vision, slit-lamp anterior segment and fundus examination as well as automatized visual field and optical coherence tomography of the optic nerves and retina. Patients will then be admitted to the Neurology and Ophthalmologic Department of the University Hospital of Martinique for optic neuritis emergency treatment, 3-Tesla brain and medullar MRIs, and ancillary testing. Specific NMO antibodies (AQP-4 and MOG) will be tested in all patients. Neuro-ophthalmic examination will be repeated after 3 days of IV steroids in order to decide on further treatment. Patients will be further monitored at 1, 6 and 12 months so as to determine the most likely etiology of optic neuritis with the aid of MS and NMO diagnosis criteria.

Arms & Interventions

Arms

Experimental: Patients with optic neuritis

Interventions

Diagnostic Test: - Neuro-ophtalmology examination

Patients will first undergo a full neuro-ophthalmic examination which includes visual acuity, contrast vision, color vision, slit-lamp anterior segment and fundus examination as well as automatized visual field and optical coherence tomography of the optic nerves and retina. Patients will then be admitted to the Neurology and Ophthalmologic Department for optic neuritis emergency treatment, 3-Tesla brain and medullar MRIs, and ancillary testing. Specific NMO antibodies (AQP-4 and MOG) will be tested in all patients. Neuro-ophthalmic examination will be repeated after 3 days of IV steroids in order to decide on further treatment.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU of Martinique, Fort-de-France, France

Status

Recruiting

Address

CHU of Martinique

Fort-de-France, , 97261

Site Contact

Philippe Cabre, MD, PhD

[email protected]

0596552261

Nearest Location

Site Contact

Philippe Cabre, MD, PhD

[email protected]

0596552261


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

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Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

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Visit NARCOMS

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If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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