Living with ocular (eye-only) myasthenia gravis?
We want to hear from people living with eye-only (ocular) symptoms of myasthenia gravis. If you or someone you know is living with ocular myasthenia gravis (oMG), this study could be of interest.
See if you or a loved one may qualify for the MyVision studyThe MyVision study is a clinical study conducted by UCB, a global biopharma company. The study is testing a study drug which is currently approved for the treatment of generalized myasthenia gravis (gMG), to see what effects it has on eye symptoms in adults with oMG. In the MyVision study, researchers want to find out if it could also help reduce symptoms of oMG.
Unlike other treatments such as corticosteroids, immunosuppressants, or immunoglobulin (Ig) infusions, the study drug takes a different approach. It works by affecting the part of the immune system that causes problems where nerves connect to muscles—which is what leads to ocular myasthenia gravis.
If you experience eye-only symptoms of myasthenia gravis and are interested in helping others like you in the future as well as advancing science research at the same time, consider participating in the MyVision study. There is no guarantee that you will directly benefit from taking part, but you will help advance knowledge about treating oMG.
If you qualify and decide to join, you will get:
The study drug or placebo (a placebo is similar to the study drug but contains no medicinally active ingredients)
The opportunity to join the extension study (MyVisionXT) where all participants will receive study drug only
Close medical care and follow-up throughout the study
Reimbursement for travel expenses and other study-related expenses may also be available.
See if you or a loved one may qualify for the MyVision study
You may be able to join if you:
Are at least 18 years of age
Have been diagnosed with oMG by a doctor
Are not experiencing weakness in other muscles in the body such as the face, throat, arms, and/or legs
The oMG diagnosis should be supported by one of the following:
- A blood test showing specific antibodies (AChR or MuSK), or
- If no antibodies are found, then nerve tests (RNS or SFEMG) plus at least one of these:
- Positive “ice test”
- Past positive edrophonium (also known as Tensilon test)
- Improvement in eye symptoms after treatments like IVIg, plasma exchange, or medications like acetylcholinesterase inhibitors, corticosteroids, or other immunosuppressive medications
There are other requirements for taking part in this study, which the study team will discuss with you. If you are already seeing a neurologist or other physician for your ocular MG, we encourage you to speak to your physician about joining the MyVision study. You can download this fact sheet to share with your physician.
You can, of course, keep seeing your regular neurologist or other physician while you’re in the study. Please make sure to inform the study team about any medications that are prescribed by any healthcare professional. It is important for the study team to be aware of all medication changes or medication updates.
See if you or a loved one may qualify for the MyVision study
The MyVision study is testing a study drug to see the effects in adults with eye-only (ocular) myasthenia gravis.
- The study drug is given under the skin (subcutaneously, also known as a SC injection) once a week and for a duration of 6 weeks.
- After you sign an informed consent form, or ICF (an ICF explains risks, benefits, and what to expect), you begin the Screening Visit (Screening includes assessments to see if the study is right for you).
- After confirming that you meet all the study criteria to participate and you consent to joining the study, you will then be randomly assigned (like flipping a coin) to receive either the study drug or a placebo (a placebo looks like the study drug but contains no active ingredients). There is a 50% chance of receiving study drug and a 50% chance of receiving placebo; neither you nor the doctors will know which one you’re getting.
- During the study, if your symptoms get worse, you may receive additional treatment, which could include starting corticosteroids or increasing your dose, IVIg (intravenous immunoglobulin), or PLEX (plasma exchange).
Depending on your response to the study drug and whether you need additional treatment, you may continue in the study and later switch to an extension study (MyVisionXT). In the MyVisionXT study, all participants will receive the study drug (no placebo).
Your decision to participate—or not participate—in this clinical study will have no effect on the medical care that you receive now or in the future.
Duration of MyVision study
The duration of participation in the MyVision lasts up to 20 weeks, consisting of the following:
Screening period:
Up to 6 weeks
Treatment period:
6 weeks (weekly doses of study drug or placebo)
Observation period:
4 to 7 weeks, depending on whether you choose to enter the open-label extension (OLE) and whether rescue medication is needed
Open-Label Extension
OLE
Up to 2 Years
What is MyVisionXT?
MyVisionXT is a separate continuation study for participants who continue to qualify to receive the study drug. In this study, everyone will receive the study drug only; no placebo will be given. Please discuss your options with the study team, including how you might continue in the MyVisionXT study.
Take the questionnaire
The following questions are designed to help find out whether a person may be eligible for participation in the MyVision study. As mentioned previously, you can fill out the pre-screener for a patient on their behalf; the term “you” refers to the potential study participant.
If you don't know whether you or someone you know meets these criteria, please speak to a member of the study team at your nearest study site. They will be happy to help you determine if you may be eligible for the study.
Find a study center
Please select the study center that is most convenient for you.
Clinical research plays a vital part of the development of new treatments. Clinical research is needed to decide whether a study drug should become available to the public.
Sometimes a drug that has already been approved in certain diseases undergoes additional testing to see if it could also help in other diseases. This is what is happening in the MyVision study where the study drug has already been approved for generalized MG and is now being tested for ocular MG.
Generally, during a clinical study, researchers may want to find out the following about a study drug:
- If it has manageable side effects
- If it works the way it is expected to
- If it works less well, the same, or better than other drugs
- How it behaves in the human body (e.g., where it is transported, how quickly it leaves the body, etc.)
Before any medication can be prescribed or made available to the public for a certain disease, it must go through clinical studies and then be approved by regulatory health organizations. These studies follow strict rules to protect the rights, safety, well-being, and privacy of participants, while providing the information health officials need to decide whether a medication is tolerated well and effective. Clinical studies are the only way new treatments can be developed.
Frequently asked questions
Ocular myasthenia gravis (oMG) is a form of MG that causes weakness in the muscle around the eyes, leading to double vision, droopy eyelids, and difficulty looking in different directions. These symptoms can make everyday activities challenging like driving, reading, and even watching television. About 15 percent of people with MG have oMG.
See https://myasthenia.org/understanding-mg/mg-related-disorders/ for more information.
During the study, if your symptoms get worse, you may receive additional treatment that could include starting corticosteroids or increasing your dose, IVIg (intravenous immunoglobulin), or PLEX (plasma exchange). The study team is happy to explain this to you in more detail; please feel free to ask them any questions about the study you may have.
The duration of participation in the MyVision lasts up to 20 weeks, consisting of the following:
- Screening period: Up to 6 weeks
- Treatment period: 6 weeks (weekly doses of study drug or placebo)
- Observation period: 4 to 7 weeks, depending on whether you choose to enter the open-label extension (OLE) and whether rescue medication is needed
Participation in any clinical study is completely voluntary. Your decision to participate – or not participate – in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the study, you may leave the clinical study at any time, and for any reason.
UCB may offer reimbursement and travel support for study-related travel and expenses. For more information, please speak with a member of the study team.
There are many reasons to participate in clinical research. Participants play an important part in bringing much-needed drugs to market, benefiting other people in the future who also have the disease or condition.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
UCB Biopharma SRL is responsible for conducting this clinical study. UCB, the sponsor, will publish a summary of the study results in plain language that will be freely accessible in the Clinical Studies section of the UCB company website. This process may take years, depending on how quickly the study can finish. UCB will provide the study results to all study doctors after the study ends, and you can ask your study doctor to talk to you about those results when they are available.
