RecruitingPHASE3INTERVENTIONAL

Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial.

This study aims to find better ways to treat Ocular Myasthenia Gravis (OMG), an autoimmune condition causing weakness in eye muscles. For some people, OMG can spread to other parts of the body, which can be serious. Currently, there isn't a proven method to stop this from happening. We are comparing the usual way of treating OMG with a new approach. The new approach involves giving a steroid medicine right after diagnosis, and if eye symptoms come back as the steroid dose is lowered, adding a medicine called rituximab. The goal is to see if this new strategy can prevent the condition from getting worse over two years and improve how patients live with OMG.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Enrolment target

128

Start

29 Apr 2025

Estimated completion

01 Jun 2029

Ocular Myasthenia Gravis

What is this study about?

This study is looking into a condition called Ocular Myasthenia Gravis (OMG). OMG is a problem with the body's immune system mistakenly attacking the connections between nerves and muscles, specifically in the eyes. This causes eye muscles to become weak, leading to symptoms like droopy eyelids or double vision.

For many people, OMG stays just in the eyes, but for about 2 to 4 out of every 10 patients, the weakness can spread to other muscles. When this happens, it can affect muscles needed for breathing, swallowing, or moving arms and legs. This is a serious development that can lead to hospital stays and the need for strong, long-term medicines. At the moment, doctors don't have a clear strategy proven to stop this from happening.

This research wants to find out if starting medication earlier can prevent OMG from spreading. We're comparing the standard approach to a new, more active one. The new approach involves giving a steroid medicine as soon as OMG is diagnosed. If eye symptoms return when the steroid dose is reduced, another medicine called rituximab might be added. The study hopes that this combination will reduce the chance of OMG getting worse and improve the long-term outlook for people with the condition. It's important to understand this research is still in the testing phase (Phase 3), meaning it's a key step towards understanding if this new approach is effective and safe.

Key takeaways

This study is for adults newly diagnosed with Ocular Myasthenia Gravis (OMG).
It tests if early steroid treatment, plus rituximab if needed, can stop OMG from spreading.
The goal is to prevent the condition from becoming more severe beyond the eyes.
Participation involves regular check-ups, medication, and monitoring for about two years.
It's a Phase 3 trial, a crucial step to seeing if this new treatment strategy is effective.

Who may be eligible?

You might be able to join this study if you are over 18 years old and have been diagnosed with Ocular Myasthenia Gravis (OMG) in the last six months. This diagnosis means your eye muscles are weak, causing things like droopy eyelids or double vision, which can vary day to day. We would also need to confirm your OMG diagnosis with tests like specific blood tests or nerve tests.

It's important that your symptoms have only affected your eyes for at least one month, and haven't spread to other muscles yet. Also, you must not have had strong immune-suppressing medicines for your OMG before joining this study.

There are also reasons why you might not be able to join. For example, if you have a tumour in your thymus gland (thymoma), other eye conditions like thyroid eye disease, or severe heart or liver problems. You also cannot be pregnant or breastfeeding. The study also cannot include you if you have allergies to any of the study medications, or if you need certain types of vaccinations during the study period.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Were you diagnosed with Ocular Myasthenia Gravis (OMG) in the last 6 months?
Are your symptoms currently only affecting your eye muscles?
Have you NOT taken strong immune-suppressing medicines for your OMG before?
Are you NOT pregnant or breastfeeding, and willing to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be randomly assigned to one of two groups: either the usual care group or the proactive treatment group. All participants will have regular check-ups with the study team. These visits will involve physical examinations, assessments of your muscle strength (especially your eye muscles), and blood tests to track your progress and check for any side effects. You will be given either standard treatment or the new combination of medications. The study will carefully monitor how the medicines affect your symptoms and overall health. We anticipate you'll be part of the study for about two years, with planned follow-up visits to understand the long-term impact of the treatments.

Potential risks and benefits

Participating in this study might offer the benefit of potentially preventing your Ocular Myasthenia Gravis from worsening and affecting other parts of your body. The treatments used are already known medicines, but they can have side effects. For example, steroids can have various side effects like weight gain, mood changes, or bone thinning, while rituximab can cause allergic reactions during infusion, infections, or other issues. The study team will closely monitor you for any side effects and manage them appropriately. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

Centre Hospitalier Universitaire De Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Hôpital Raymond Pointcarre
Verified postcode
Garches, France· Not yet recruiting
Centre Hospitalier Universitaire De Lille
Verified postcode
Lille, France· Recruiting
Hospices Civils De Lyon
Verified postcode
Lyon, France· Recruiting
Centre Hospitalier Universitaire De Nice
Verified postcode
Nice, France· Recruiting
CHNO
Verified postcode
Paris, France· Active not recruiting
Hôpital de la Pitié-Salpêtrière
Verified postcode
Paris, France· Not yet recruiting
Centre Hospitalier Sainte Anne
Verified postcode
Paris, France· Active not recruiting
Fondation Adolphe de Rothschild
Verified postcode
Paris, France· Recruiting
Les Hopitaux Universitaires De Strasbourg
Verified postcode
Strasbourg, France· Recruiting
Centre Hospitalier Universitaire De Toulouse
Verified postcode
Toulouse, France· Active not recruiting

Common questions

What is Ocular Myasthenia Gravis (OMG)?

OMG is a condition where your body's immune system affects your eye muscles, causing weakness and symptoms like droopy eyelids or double vision.

Why is it important to prevent OMG from spreading?

If OMG spreads to other muscles, it can cause more serious problems with breathing, swallowing, or movement, which can be very serious.

What kind of medicines are being tested?

The study is looking at starting steroid medicine sooner, and possibly adding another medicine called rituximab, to see if this helps prevent the condition from getting worse.

How long will I be in the study?

If you join, you will likely be involved in the study for about two years, with regular check-ups.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and this will not affect your future medical care.

How to find out more

Antoine Gueguen

agueguen@for.paris +33148036852 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.