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New strategy aims to stop eye muscle disease from spreading

NCT ID NCT06342544

Disease control Sponsor: Fondation Ophtalmologique Adolphe de Rothschild Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether starting steroids right away, and adding rituximab if symptoms return, can prevent eye muscle weakness from spreading to other muscles in people with ocular myasthenia gravis. About 128 adults with recent diagnosis will be followed for 2 years. The goal is to reduce the risk of severe generalized weakness that often requires long-term medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ocular myasthenia gravis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHNO

    ACTIVE_NOT_RECRUITING

    Paris, 75012, France

  • Centre Hospitalier Sainte Anne

    ACTIVE_NOT_RECRUITING

    Paris, 75014, France

  • Centre Hospitalier Universitaire De Bordeaux

    RECRUITING

    Bordeaux, 33000, France

  • Centre Hospitalier Universitaire De Lille

    RECRUITING

    Lille, 59037, France

  • Centre Hospitalier Universitaire De Nice

    RECRUITING

    Nice, 06000, France

  • Centre Hospitalier Universitaire De Toulouse

    ACTIVE_NOT_RECRUITING

    Toulouse, 31300, France

  • Fondation Adolphe de Rothschild

    RECRUITING

    Paris, 75019, France

  • Hospices Civils De Lyon

    RECRUITING

    Lyon, 69500, France

  • Hôpital Raymond Pointcarre

    NOT_YET_RECRUITING

    Garches, 92380, France

  • Hôpital de la Pitié-Salpêtrière

    NOT_YET_RECRUITING

    Paris, 75013, France

  • Les Hopitaux Universitaires De Strasbourg

    RECRUITING

    Strasbourg, 67098, France

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Other studies related to the condition(s) this trial covers.