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Optic Neuritis Differential Diagnosis Study (ONDDS)

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ClinicalTrials.gov Identifier: NCT03370965
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : August 1, 2019
Sponsor:
Collaborators:
University Hospital Center of Guadeloupe
Hospital Center of Cayenne (French Guyana)
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Optic Neuritis Neuromyelitis Optica Multiple Sclerosis Diagnostic Test: Neuro-ophtalmology examination Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optic Neuritis Differential Diagnosis Study (ONDDS)
Actual Study Start Date : June 7, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2025


Arm Intervention/treatment
Experimental: Patients with optic neuritis 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.





Primary Outcome Measures :
  1. Final diagnosis using MS (McDonald, 2010) - Spatial dissemination [ Time Frame: 12 months ]

    One T2 lesion ore more in at least two of the four central nervous system territories considered to be characteristic of MS:

    • juxtacortical,
    • periventricular,
    • sub-tentorial,
    • medullary (in case of medullary syndrome or brain stem, symptomatic lesions are excluded from the diagnostic criteria and do not participate in the lesion count).

  2. Final diagnosis using MS (McDonald, 2010) - Time dissemination [ Time Frame: 12 months ]
    • A new lesion in T2 and / or a lesion taking gadolinium on a follow-up MRI regardless of the time of initial MRI.
    • The simultaneous presence of asymptomatic lesions raised and not elevated by gadolinium at any time.

  3. NMO diagnosis criteria (Wingerchuk, 2015) - Diagnosis of NMO-SD with positive anti-AQP4 Antibody [ Time Frame: 12 months ]
    • At least one main clinical criterion (1)
    • Exclusion of other diagnoses

  4. NMO diagnosis criteria (Wingerchuk, 2015) - Diagnosis of NMO-SD with anti-AQP4 negative antibody [ Time Frame: 12 months ]
    • At least 2 main clinical criteria occurring in the context of one or more clinical outbreaks and meeting the following criteria

      • At least 1 of the 2 main clinical criteria should be optic neuritis, extensive longitudinal myelitis or area postrema syndrome.
      • Dissemination in space (at least 2 main criteria)
      • Respect of MRI imaging criteria (2)
    • Anti-AQP4 negative antibodies
    • Exclusion of differential diagnoses



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370965


Contacts
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Contact: Philippe CABRE, PhD 0596552261 ext +596 philippe.cabre@chu-martinique.fr
Contact: Harold MERLE, MD 0596552251 ext +596 harold.merle@chu-martinique.fr

Locations
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France
CHU of Martinique Recruiting
Fort-de-France, France, 97261
Contact: Philippe Cabre, MD, PhD         
Principal Investigator: Philippe Cabre, MD, PhD         
Sponsors and Collaborators
University Hospital Center of Martinique
University Hospital Center of Guadeloupe
Hospital Center of Cayenne (French Guyana)
Investigators
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Principal Investigator: Philippe CABRE, PhD Centre Hospitalier Universitaire de Martinique

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT03370965     History of Changes
Other Study ID Numbers: 17/B/01
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Center of Martinique:
optic neuritis
neuromyelitis optica
multiple sclerosis
emergent treatment of optic neuritis
optic neuritis disease modifying therapy
optic neuritis treatment trial
plasma exchange
Additional relevant MeSH terms:
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Neuromyelitis Optica
Multiple Sclerosis
Neuritis
Optic Neuritis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Myelitis, Transverse