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Study on the Effects of RO7200220 for Patients with Uveitic Macular Edema

Verified siteInvestigationalNo placebo

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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 known as RO7200220, which is a type of medication called a humanised IgG2 monoclonal antibody against interleukin-6. This medication is given as a solution for injection directly into the eye, a method known as intravitreal use.

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 RO7200220 treatment or a placebo. The study will monitor changes in vision and eye health over time, with key assessments occurring at weeks 16, 20, and 52. The study will also look at how the medication moves through the body and its effects on the eye and overall health.

Throughout the study, participants will have regular check-ups to assess their vision and the thickness of the retina, as well as to monitor any side effects. The study aims to determine if the treatment can improve vision and reduce swelling in the retina, providing valuable information for managing uveitic macular edema.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, a detailed eye examination will be conducted to confirm the diagnosis of uveitic macular edema. This includes using a special imaging technique called spectral-domain optical coherence tomography (SD-OCT) to measure the thickness of the macula, which is the central part of the retina.
Your visual acuity, or clarity of vision, will be assessed using a chart similar to those used in eye exams. This is known as the best corrected visual acuity (BCVA) test. Your score should be between 73 and 19 letters, which corresponds to a vision range of 20/40 to 20/400.
Step 2
Randomization and treatment
After the initial assessments, you will be randomly assigned to receive either the study medication, IL6-Mab, or a sham treatment. The study medication is a solution for injection that targets a specific protein involved in inflammation.
The medication is administered through an intravitreal injection, which means it is injected directly into the eye. This procedure will be performed by a trained healthcare professional.
Step 3
Treatment period
The treatment period involves regular visits to receive the intravitreal injections. The frequency and duration of these injections will be determined by the study protocol and your specific treatment group.
Throughout the treatment period, your vision and eye health will be closely monitored. This includes regular BCVA tests and SD-OCT scans to track changes in your macular thickness and visual acuity.
Step 4
Follow-up assessments
At specific intervals, such as weeks 16, 20, and 52, follow-up assessments will be conducted to evaluate the effectiveness of the treatment. These assessments will measure any improvements in your BCVA score and changes in the thickness of your macula.
Additional tests may be performed to monitor the concentration of the study medication in your body and to check for any potential side effects or adverse reactions.
Step 5
End of study
The study is expected to conclude by June 2025. At the end of the study, a final assessment will be conducted to evaluate the overall outcomes of the treatment.
You will receive information about the results of the study and any further steps or recommendations for your eye care.

Who can join the trial?

5 criteria

Must have a diagnosis of macular edema (swelling in the central part of the retina) associated with non-infectious uveitis (inflammation of the eye not caused by an infection), confirmed by an eye scan called spectral-domain optical coherence tomography (SD-OCT).
Must have a diagnosis of active or inactive, acute (sudden) or chronic (long-lasting) non-infectious uveitis (NIU) of any cause and affecting any part of the eye (front, middle, back, or all parts), as determined by the study doctor.
Must have a best corrected visual acuity (BCVA) score between 73 and 19 letters on a special eye chart used in research (equivalent to seeing between 20/40 and 20/400 on a standard eye chart) on the first day of the study, as measured at the study site.
Open to both male and female participants.
Includes participants from vulnerable populations, which may include groups like children or those with certain health conditions.

Who cannot join the trial?

8 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 using or have used certain medications that could affect the study results.
Patients with uncontrolled high blood pressure.
Patients with a history of severe allergic reactions.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial in the last 30 days.
Patients with any condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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ASST Fatebenefratelli Sacco
Verified
Milan, Italy
Assistance Publique Hopitaux De Paris
Verified
Paris, France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain

Trial locations

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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 back part of the eye, which is called macular edema. This swelling is often caused by a condition known as uveitis, which is an inflammation inside the eye. By reducing the swelling, the medication aims to improve vision and prevent further damage to the eye. The trial is designed to see how well this medication works and to check its safety for patients with this eye condition.

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 a Phase III clinical trial 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 trial is to determine how well RO7200220 improves vision and other functional outcomes compared to a placebo treatment. At the molecular level, the medication is designed to target specific pathways involved in inflammation and fluid accumulation in the eye, although the exact mechanism is still under investigation. RO7200220 falls under the pharmacological classification of investigational drugs, as it is not yet approved for general medical use.

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 inflammation can cause the blood vessels in the retina to leak, leading to swelling and thickening of the macula. As the macula swells, it can distort vision, making it blurry or wavy, and can affect the ability to see fine details. The progression of the disease can vary, with periods of worsening symptoms followed by improvement. Over time, repeated episodes of edema can lead to permanent changes in vision. The condition is often associated with other inflammatory diseases affecting the eye.