Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE MASKED, SHAM-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200220 ADMINISTERED INTRAVITREALLY IN PATIENTS WITH UVEITIC MACULAR EDEMA

This study is investigating a new treatment for uveitic macular edema (UME). UME is a condition where swelling occurs at the back of the eye (the macula) due to inflammation (uveitis), which can blur your vision. The treatment involves an injection directly into the eye. Researchers want to find out if this treatment significantly improves vision and is safe for people 18 years and older with UME. They will compare it to a dummy treatment (sham control) to see its true effects. This is a crucial step in potentially getting a new medication approved to help patients with this eye condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

20 Apr 2023

Uveitic Macular Edema

What is this study about?

This study is looking at a new medicine for a condition called uveitic macular edema (UME). Uveitis is when the middle layer of your eye becomes inflamed. Sometimes, this inflammation can lead to swelling in a small, important part of your retina called the macula. This swelling, known as macular edema, can make your vision blurry or distorted.

The new medicine being tested is designed to help reduce this swelling. It will be given as an injection directly into the eye. The main goal of the study is to see if this new treatment can improve people's eyesight. Specifically, they want to know if it can help participants read at least 15 more letters on an eye chart after 16 weeks compared to before they started the treatment.

This is a 'Phase III' study, which means it's one of the last steps before a medicine might be approved for wider use. It's 'double-masked,' meaning neither you nor your study doctor will know if you're receiving the new medicine or a dummy treatment, to ensure the results are as fair and unbiased as possible. The study will also carefully check for any side effects and how the medicine works in the body over time.

Key takeaways

A study testing a new eye injection for blurry vision from uveitis.
Aims to improve eyesight and reduce eye swelling.
Compares the new treatment to a dummy injection.
Participation involves regular eye checks and injections.
Results will help decide if the treatment becomes widely available.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women are welcome to participate.

More specific medical details will determine if you are a good fit for this study. These details usually involve confirming you have active uveitic macular edema and meeting certain health criteria to ensure your safety throughout the trial. Your eye doctor would check these specific requirements with you.

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?
Do you have a diagnosis of uveitic macular edema?
Are you able to attend regular clinic appointments for about a year?
Are you willing to receive eye injections as part of the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to either receive the new study medicine or a dummy treatment (a sham procedure that mimics the injection but doesn't contain the medicine). You'll have regular visits to the clinic, which will involve eye exams, blood tests, and scans of your eye. You'll receive injections into your eye at specific times throughout the study period. Your vision will be tested regularly using eye charts, and specialists will check for any changes in the swelling at the back of your eye. The study will also track any side effects. The total duration of your participation will involve follow-up appointments over many weeks, possibly up to a year, to see how the treatment works long-term.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that could improve your vision if you get the active medicine. However, there's no guarantee the treatment will work for you, and like all medicines and procedures, there are potential risks, including side effects from the injections or the drug itself. These risks will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Germany
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Unverified
Czechia
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Unverified
France
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Unverified
Italy
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Unverified
Portugal
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Unverified
Poland

Common questions

What is uveitic macular edema (UME)?

UME is swelling at the back of your eye (the macula) caused by inflammation called uveitis, which can make your vision blurry.

What kind of treatment is being tested?

It's a new medicine called RO7200220, given as an injection directly into the eye.

Will I know if I'm getting the real medicine or not?

No, this is a 'double-masked' study, meaning neither you nor your doctor will know which treatment you are receiving until after the study is over.

What is the main goal of this study?

The main goal is to see if the new medicine improves eyesight by at least 15 letters on an eye chart within 16 weeks.

How long will I be in the study?

Your participation will involve regular visits and follow-up for up to a year to monitor effects and safety.