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New treatment option for Ocular Myasthenia Gravis
Official title Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial.
ClinicalTrials.gov ID: NCT06342544
What this study is testing
What is immediate treatment with corticosteroids?
immediate treatment with corticosteroids is an investigational medicine, being studied as a potential treatment for ocular myasthenia gravis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness. In the initial phase of the disease, 70% of patients present with ocular onset myasthenia (OMG), i.e.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients over 18 years of age
- Diagnosis of ocular myasthenia within the last 6 months, defined :
- either by a typical clinical examination objectified by an expert clinician: ptosis and/or binocular diplopia, with a variable and fluctuating...
- or by positive anti-AChR antibodies or the presence of decrement on repetitive nerve stimulation or a positive edrophonium test
- Ocular symptoms lasting at least one month and limited to extra-ocular muscles (weakness in one or both orbicularis oculi)
You likely can't join if
- Thymoma
- Pupillary anomaly other than that resulting from previous local disease or surgery.
- Signs of restrictive abduction or supraduction myopathy due to dysthyroid ophthalmopathy.
- Graves' ophthalmopathy
- Onset of ocular symptoms more than one year before screening date
- Hypersensitivity to rituximab, murine proteins, prednisone, methylprednisone, aziathioprine or 6-mercaptopurine, paracetamol, dexchlorpheniramine.
See the full eligibility criteria
- Patients over 18 years of age
- Diagnosis of ocular myasthenia within the last 6 months, defined :
- either by a typical clinical examination objectified by an expert clinician: ptosis and/or binocular diplopia, with a variable and fluctuating character (either spontaneous or provoked by effort or rest)
- or by positive anti-AChR antibodies or the presence of decrement on repetitive nerve stimulation or a positive edrophonium test
- Ocular symptoms lasting at least one month and limited to extra-ocular muscles (weakness in one or both orbicularis oculi)
- No non-ocular symptoms on MMS, MGC and MG-ADL.
- Naïve to immunosuppressive therapy for ocular myasthenia gravis.
- Thymoma
- Pupillary anomaly other than that resulting from previous local disease or surgery.
- Signs of restrictive abduction or supraduction myopathy due to dysthyroid ophthalmopathy.
- Graves' ophthalmopathy
- Onset of ocular symptoms more than one year before screening date
- Hypersensitivity to rituximab, murine proteins, prednisone, methylprednisone, aziathioprine or 6-mercaptopurine, paracetamol, dexchlorpheniramine.
- Any infectious condition
- Patients with severe immune deficiency
- Severe heart failure (New York Heart Association (NYHA) Class IV) or severe uncontrolled heart disease
- Severe hepatic insufficiency
- Psychotic states not yet controlled by treatment
- Hyperuricemia on xanthine oxidase inhibitors (allopurinol and febuxostat)
- Risk of angle-closure glaucoma
- Risk of urinary retention due to urethro-prostatic disorders
- Vaccination with live attenuated vaccine required during study and up to 6 months after rituximab discontinuation
- Women of childbearing age who do not wish to use effective contraception during their participation and at least 12 months after
- Pregnant or breast-feeding women
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Garches, France
- Lille, France
- Lyon, France
- Nice, France
- Paris, France
- Strasbourg, France
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Garches, France; Lille, France; Lyon, France; Nice, France; Paris, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.