Optic Neuritis Differential Diagnosis Study

NCT03370965 | Unknown

• 1 other identifier: 17/B/01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Neuritis; Neuromyelitis Optica; Multiple Sclerosis

Keywords

optic neuritis; neuromyelitis optica; multiple sclerosis; emergent treatment of optic neuritis; optic neuritis disease modifying therapy; optic neuritis treatment trial; plasma exchange

Outcome Measures

Primary Outcomes (4)

• Final diagnosis using MS (McDonald, 2010) - Spatial dissemination

  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).

  12 months

• Final diagnosis using MS (McDonald, 2010) - Time dissemination

  * 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.

  12 months

• NMO diagnosis criteria (Wingerchuk, 2015) - Diagnosis of NMO-SD with positive anti-AQP4 Antibody

  * At least one main clinical criterion (1) * Exclusion of other diagnoses

  12 months

• NMO diagnosis criteria (Wingerchuk, 2015) - Diagnosis of NMO-SD with anti-AQP4 negative antibody

  * 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

  12 months

Study Arms (1)

Patients with optic neuritis

EXPERIMENTAL

Diagnostic Test: Neuro-ophtalmology examination

Interventions

Neuro-ophtalmology examination DIAGNOSTIC_TEST

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.

Patients with optic neuritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients known to have an inflammatory disease of the central nervous system (MS, NMO, EMAD).
• Known history of inflammatory pathology (lupus or sarcoidosis) or infectious pathology (syphilis, HIV) that may give rise to optical neuropathy.
• Table suggestive of Leber's hereditary optic neuropathy (genetically confirmed).
• Treatment in progress known to give optical neuropathies.
• Consumption of toxic known to give optical neuropathies.
• 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.
• Arguments for non-arteritic ischemic optic neuropathy defined by all of the following criteria:
• Absence of pain in eye movements.
• Altitudinal deficit of the visual field.
• Choroidal ischemia with fluorescein angiography.
• Presence of cardiovascular risk factors.
• Absence of neurological signs related to inflammatory disease of the central nervous system.
• Arguments for arterial ischemic optic neuropathy defined by all of the following criteria:
• Absence of pain in eye movements.
• Altitudinal deficit of the visual field.

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• University Hospital Center of Guadeloupe: collaborator
• Hospital Center of Cayenne (French Guyana): collaborator

Study Sites (1)

CHU of Martinique

Fort-de-France, 97261, France

RECRUITING

MeSH Terms

Conditions

Optic Neuritis; Neuromyelitis Optica; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Philippe CABRE, PhD

  Centre Hospitalier Universitaire de Martinique

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe CABRE, PhD

CONTACT

0596552261; philippe.cabre@chu-martinique.fr

Harold MERLE, MD

CONTACT

0596552251; harold.merle@chu-martinique.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: December 13, 2017
• Study Start: June 7, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)