Study on the Effects of RO7200220 for Patients 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 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.

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.

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.

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.

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.

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 Study?

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 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 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Hospital Clinico San Carlos	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Fakultni Nemocnice Brno	Brno	Czechia
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
ASST Fatebenefratelli Sacco	Milan	Italy
Association For Innovation And Biomedical Research On Light And Image	Coimbra	Portugal
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Assistance Publique Hopitaux De Paris	Paris	France
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Knappschaft Kliniken Saar GmbH	Sulzbach	Germany
Augenzentrum Am St Franziskus-Hospital Muenster	Munster	Germany
Centre Monticelli Paradis D Ophtalmologie	Marseille	France
Ulnpdtkhcq Mccbyyi Cyemxi Hrxcnajdtawmytqlt	Hamburg	Germany
Uzjisqbscp Hwyusays Cdyagxj	Cologne	Germany
Anohlvyifg Pipvxzrg Hplwcywt Dj Pxxqx	Paris	France
Axefkpxtns Pvordzay Hbqwapxf Dd Pjsee	Paris	France
Axqeokv Uav Iyxje Db Rhenvw Ewzsip	Reggio Emilia	Italy
Cbd Cuktq Rexexwtluhv	Lyon	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	29.03.2023
France	Not recruiting	29.03.2023
Germany	Not recruiting	29.03.2023
Italy	Not recruiting	29.03.2023
Poland	Not yet recruiting	29.03.2023
Portugal	Not recruiting	29.03.2023
Spain	Not recruiting	29.03.2023

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 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.

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.

Trial ID:

2022-501794-39-00

Protocol code:

GR44278

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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