Optic NeuritisONDDSNCT03370965
Optic Neuritis Differential Diagnosis Study
A study testing Neuro-ophtalmology examination in people with Optic Neuritis and Neuromyelitis Optica, run by University Hospital Center of Martinique at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Optic Neuritis, Neuromyelitis Optica, Multiple Sclerosis
- What is being tested?
- Neuro-ophtalmology examination
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2019to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU of Martinique
Fort-de-France, 97261
Philippe Cabre, MD, PhD
Philippe Cabre, MD, PhD
About this study
Official title: Optic Neuritis Differential Diagnosis Study (ONDDS)
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.
Read the 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.
- Conditions
- Optic Neuritis, Neuromyelitis Optica, Multiple Sclerosis
- Being tested
- Neuro-ophtalmology examination
- Keywords
- optic neuritis, neuromyelitis optica, multiple sclerosis, emergent treatment of optic neuritis, optic neuritis disease modifying therapy, optic neuritis treatment trial, plasma exchange
- Medical subject headings
- Optic Neuritis, Neuromyelitis Optica, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-ophtalmology examinationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with optic neuritis | Experimental | Not described Receives: Diagnostic Test: Neuro-ophtalmology examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start7 Jun 2019
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Center of Guadeloupe, Hospital Center of Cayenne (French Guyana)
- Responsible party
- Sponsor
- Investigators
- Philippe CABRE, PhD, Principal investigator, Centre Hospitalier Universitaire de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370965
- Sponsor's protocol ID
- 17/B/01
- Acronym
- ONDDS
- Status last verified
- Feb 2022
- First submitted
- 20 Oct 2017
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Neuritis Differential Diagnosis Study (ONDDS)
- ClinicalTrials.gov ID
- NCT03370965
- Acronym / sponsor ID
- ONDDS / 17/B/01
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- University Hospital Center of Guadeloupe, Hospital Center of Cayenne (French Guyana)
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with optic neuritis | Experimental | Diagnostic Test: Neuro-ophtalmology examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient aged 18 years or older at time of inclusion.
- Table of unilateral or bilateral optic neuritis defined as follows (clinical diagnosis):
- Patient (s) affiliated to a social security scheme (beneficiary or beneficiary).
- Patient who has given free and written consent.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro-ophtalmology examinationPatients 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. | Diagnostic test | Patients with optic neuritis |
Primary outcome
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).
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe CABRE, PhD principal investigator
Centre Hospitalier Universitaire de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-ophtalmology examination in people with Optic Neuritis and Neuromyelitis Optica, run by University Hospital Center of Martinique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe CABRE, PhD (0596552261 ext. +596, philippe.cabre@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final diagnosis using MS (McDonald, 2010) - Spatial dissemination (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.