Not recruiting

Study on the Effects of RO7200220 for Adults and Children with Uveitic Macular Edema

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Uveitic Macular Edema, which is a swelling in the central part of the retina, often associated with inflammation in the eye. The study is testing a treatment called RO7200220, also known by its code name IL6-Mab. This treatment is a type of medication known as a humanised IgG2 monoclonal antibody against interleukin-6, which is designed to target and reduce inflammation. The medication is given as a solution for injection directly into the eye.

The purpose of the study is to evaluate how effective and safe this treatment is for patients with Uveitic Macular Edema. Participants in the study will receive either the actual medication or a placebo. The study will monitor changes in vision and eye health over time, with particular attention to improvements in visual clarity and reductions in retinal swelling. The study will also assess the safety of the treatment by tracking any side effects that may occur.

Throughout the study, participants will have regular check-ups to measure their vision and eye condition. The study will last for a period of up to 52 weeks, during which the effects of the treatment will be closely observed. The goal is to determine if the treatment can significantly improve vision and reduce swelling in the retina for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. You will be asked to provide consent to participate in the trial.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes a diagnosis of macular edema associated with non-infectious uveitis, confirmed by an eye scan called spectral-domain optical coherence tomography (SD-OCT).
Your vision will be tested using a chart similar to the Early Treatment Diabetic Retinopathy Study (ETDRS) chart to ensure it falls within the required range.
Step 3
Treatment administration
You will receive the study medication, IL6-Mab, which is a solution for injection. This medication is administered through an intravenous injection.
The frequency and dosage of the medication will be determined by the study protocol and communicated to you by the study team.
Step 4
Follow-up visits
You will have regular follow-up visits to monitor your response to the treatment. These visits will include vision tests and eye examinations to assess any changes in your condition.
The primary goal is to evaluate the improvement in your vision, specifically looking for a 15-letter improvement from baseline in your best corrected visual acuity (BCVA) at Week 16.
Step 5
Additional assessments
Throughout the study, additional assessments will be conducted to monitor the safety and effectiveness of the treatment. This includes measuring changes in the thickness of the central part of your retina and checking for any side effects.
Blood samples may be taken to measure the concentration of the study drug in your body and to check for any immune response to the medication.
Step 6
Completion of the study
The study is expected to continue until June 2025. Upon completion, you will have a final assessment to evaluate the overall outcomes of the treatment.
Results from the study will contribute to understanding the effectiveness and safety of the treatment for uveitic macular edema.

Who can join the trial?

5 criteria

Must have a diagnosis of macular edema associated with non-infectious uveitis (NIU). This means there is swelling in the central part of the retina (macula) due to inflammation that is not caused by an infection.
Must have a diagnosis of active or inactive, acute, or chronic NIU of any cause and any type. This includes inflammation in the front (anterior), middle (intermediate), back (posterior), or all parts (panuveitis) of the eye.
Must have a best corrected visual acuity (BCVA) letter score between 73 and 19 letters on a special eye chart used in research studies. This is similar to having vision between 20/40 and 20/400 on a standard eye chart.
Open to both males and females.
Participants of various age groups are eligible.

Who cannot join the trial?

9 criteria

Patients with any other eye disease that could affect vision.
Patients who have had eye surgery in the last 3 months.
Patients who are currently receiving treatment for uveitic macular edema with other medications.
Patients with a history of severe allergic reactions to any of the study medications.
Patients who are pregnant or breastfeeding.
Patients with uncontrolled high blood pressure.
Patients with a history of drug or alcohol abuse in the past year.
Patients who have participated in another clinical trial in the last 30 days.
Patients with any condition that the study doctor believes would make it unsafe for them to participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Kepler Universitaetsklinikum GmbH
Verified
Linz, Austria
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

RO7200220 is a medication being tested in this clinical trial. It is given as an injection directly into the eye, a method known as intravitreal administration. The purpose of this medication is to help reduce swelling in the eye, specifically in a condition called uveitic macular edema. This condition can cause vision problems, and the medication aims to improve vision by reducing the swelling. The trial is designed to see how well this medication works and to check its safety for patients. The study also looks at how the body processes the medication and how it affects the eye over time.

Humanised Igg2 Monoclonal Antibody Against Interleukin-6

What is already known about the treatment

RO7200220 – This medication is administered through an injection directly into the eye, a method known as intravitreal injection. It is currently being studied in clinical trials to assess its effectiveness and safety for treating uveitic macular edema, a condition that causes swelling in the central part of the retina due to inflammation. The main goal of the medication is to improve vision by reducing this swelling. At the molecular level, RO7200220 works by targeting specific pathways involved in inflammation, helping to decrease the fluid buildup in the retina. It is classified under pharmacological agents that address eye inflammation and related conditions.

Investigated diseases

Uveitic Macular Edema – Uveitic Macular Edema is a condition characterized by the accumulation of fluid in the macula, the central part of the retina, due to inflammation in the uvea, which is the middle layer of the eye. This fluid buildup leads to swelling and can cause vision distortion or blurriness. The progression of the disease involves persistent inflammation that can lead to chronic swelling if not managed. Over time, the continuous presence of fluid can damage the macular tissue, potentially affecting central vision. The condition is often associated with uveitis, an inflammation of the uvea, which can be caused by various factors, including autoimmune disorders or infections. The severity and progression can vary, with some individuals experiencing more rapid changes in vision than others.