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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria

Other Sites

Site Name	City	Country
Spektrum Sp. z o.o.	Wroclaw	Poland
Azienda Unita Sanitaria Locale Di Reggio Emilia	Reggio Emilia	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Kepler Universitaetsklinikum GmbH	Linz	Austria
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Association For Innovation And Biomedical Research On Light And Image	Coimbra	Portugal
ASST Fatebenefratelli Sacco	Milan	Italy
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
The Rotterdam Eye Hospital	Rotterdam	The Netherlands
Azienda Sociosanitaria Ligure N 4 Sistema Sanitario Regione Liguria	Chiavari	Italy
Oftalmika Sp. z o.o.	Bydgoszcz	Poland
Gqileng Oeirqmqaxfbs phoim Ejxmxl Wiveayoh	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	28.02.2023
Italy	Not recruiting	28.02.2023
Poland	Not recruiting	28.02.2023
Portugal	Not recruiting	28.02.2023
The Netherlands	Not recruiting	28.02.2023

Trial locations

Investigated drugs:

Humanised Igg2 Monoclonal Antibody Against Interleukin-6

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.

Investigated diseases:

Macular oedema

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.

Trial ID:

2022-501793-19-00

Protocol code:

GR44277

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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