Back to resultsOptic Neuritis Differential Diagnosis Study (ONDDS)
Primary Purpose
Optic Neuritis, Neuromyelitis Optica, Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuro-ophtalmology examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Optic Neuritis focused on measuring optic neuritis, neuromyelitis optica, multiple sclerosis, emergent treatment of optic neuritis, optic neuritis disease modifying therapy, optic neuritis treatment trial, plasma exchange
Eligibility Criteria
Inclusion Criteria:
- Patient aged 18 years or older at time of inclusion.
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.
Exclusion Criteria:
- 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.
- Choroidal ischemia with fluorescein angiography.
- Presence of symptoms suggestive of Horton's disease.
- Absence of neurological signs related to inflammatory disease of the central nervous system.
- Pregnant and lactating patients.
Sites / Locations
- CHU of MartiniqueRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with optic neuritis
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03370965
First Posted
October 20, 2017
Last Updated
February 22, 2022
Sponsor
University Hospital Center of Martinique
Collaborators
University Hospital Center of Guadeloupe, Hospital Center of Cayenne (French Guyana)
1. Study Identification
Unique Protocol Identification Number
NCT03370965
Brief Title
Optic Neuritis Differential Diagnosis Study
Acronym
ONDDS
Official Title
Optic Neuritis Differential Diagnosis Study (ONDDS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Center of Martinique
Collaborators
University Hospital Center of Guadeloupe, Hospital Center of Cayenne (French Guyana)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with optic neuritis
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Neuro-ophtalmology examination
Intervention Description
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 Measure Information:
Title
Final diagnosis using MS (McDonald, 2010) - Spatial dissemination
Description
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).
Time Frame
12 months
Title
Final diagnosis using MS (McDonald, 2010) - Time dissemination
Description
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.
Time Frame
12 months
Title
NMO diagnosis criteria (Wingerchuk, 2015) - Diagnosis of NMO-SD with positive anti-AQP4 Antibody
Description
At least one main clinical criterion (1)
Exclusion of other diagnoses
Time Frame
12 months
Title
NMO diagnosis criteria (Wingerchuk, 2015) - Diagnosis of NMO-SD with anti-AQP4 negative antibody
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient aged 18 years or older at time of inclusion.
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.
Exclusion Criteria:
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.
Choroidal ischemia with fluorescein angiography.
Presence of symptoms suggestive of Horton's disease.
Absence of neurological signs related to inflammatory disease of the central nervous system.
Pregnant and lactating patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe CABRE, PhD
Phone
0596552261
Ext
+596
Email
philippe.cabre@chu-martinique.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Harold MERLE, MD
Phone
0596552251
Ext
+596
Email
harold.merle@chu-martinique.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe CABRE, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Martinique
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU of Martinique
City
Fort-de-France
ZIP/Postal Code
97261
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Cabre, MD, PhD
First Name & Middle Initial & Last Name & Degree
Philippe Cabre, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Optic Neuritis Differential Diagnosis Study
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