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Study on BI 764524 for Patients with Moderate to Severe Diabetic Retinopathy

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What is this study about?

This clinical trial is focused on studying a condition called diabetic retinopathy, which affects the eyes of people with diabetes. The trial will test a treatment called BI 764524, which is given as a solution for injection directly into the eye. The purpose of the study is to see if this treatment can help improve the condition of the eye in people with moderately-severe to severe non-proliferative diabetic retinopathy.

Participants in the study will receive either the BI 764524 treatment or a sham injection procedure, which is a procedure that mimics the injection but does not contain the active treatment. The study will last for 72 weeks, during which the safety and effectiveness of the treatment will be monitored. The main goal is to observe if there is a significant improvement in the eye condition after receiving the treatment.

Throughout the study, participants will have regular check-ups to monitor their eye health and any changes in their condition. The study aims to provide valuable information on whether BI 764524 can be a beneficial treatment option for people with diabetic retinopathy, potentially leading to better management of this eye condition.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age, diagnosis of diabetes, and the severity of your eye condition, known as diabetic retinopathy.

Your eye health will be assessed through various tests, including a detailed eye examination and imaging to evaluate the condition of your retina.

2 treatment assignment

You will be randomly assigned to receive either the study medication, BI 764524, or a sham injection procedure. This process is double-masked, meaning neither you nor the study team will know which treatment you are receiving.

The study medication is administered through an injection into the eye, known as an intravitreal injection.

3 treatment phase

During the treatment phase, you will receive injections according to the assigned dosing regimen. The frequency and duration of these injections will be determined by the study protocol.

Regular follow-up visits will be scheduled to monitor your response to the treatment and to assess any changes in your eye condition.

4 mid-study assessment

At approximately week 52, a comprehensive assessment will be conducted to evaluate the effectiveness of the treatment. This includes measuring any improvement in your diabetic retinopathy severity and checking for any side effects.

Your visual acuity and retinal thickness will also be measured to assess any changes from the baseline.

5 end of study visit

At the end of the 72-week study period, a final visit will be conducted. This visit will include a thorough examination to determine the overall impact of the treatment on your eye condition.

The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who Can Join the Study?

  • Must be a male or female who is 18 years or older.
  • Must have a diagnosis of diabetes mellitus (DM), which is a condition where the body has trouble managing blood sugar levels. The diabetes should be under regular treatment, and the blood sugar level (measured as HbA1c) should be less than 12%. Regular check-ups by a specialist are required before and during the trial.
  • Must have moderately severe to severe non-proliferative diabetic retinopathy (NPDR), which is a specific stage of diabetic eye disease. This will be confirmed by a central reading center.
  • Must have retinal non-perfusion (RNP), which means areas of the retina are not getting enough blood. This will be checked using a special eye test called ultra-widefield fluorescein angiography (UWF-FA). The affected area should be at least 12.5 mm² (about 5 disc areas) within a specific part of the eye.
  • Must have a visual acuity of at least 49 letters on an eye chart used at a 4-meter distance. Visual acuity is a measure of how well you can see details.
  • Must have clear enough eye media (the parts of the eye that light passes through), and the pupils must be able to dilate adequately. The person must also be able to fixate their gaze properly to allow for quality imaging of the back of the eye (fundus).

Who Cannot Join the Study?

  • Patients who do not have diabetic retinopathy cannot participate. Diabetic retinopathy is an eye condition that can occur in people with diabetes, affecting the blood vessels in the retina.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
IRCCS Humanitas Research Hospital Rozzano Italy
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu Wroclaw Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Hospital Clinico San Carlos Madrid Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Hospital Universitari General De Catalunya Sant Cugat Del Valles Spain
Hospital Universitario 12 De Octubre Madrid Spain
Warszawski Szpital Okulistyczny Sp. z o.o. Warsaw Poland
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. Olsztyn Poland
Diakonie Klinikum Dietrich Bonhoeffer GmbH Neubrandenburg Germany
Nozologen Kft. Pecs Hungary
Instituto Di Ricovero E Cura A Carattere Scientifico Bologna Italy
Centrum Medyczne Piasta 47 Walbrzych Poland
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Semmelweis University Budapest Hungary
Universita’ Politecnica Delle Marche Ancona Italy
Hospital General Universitario De Valencia Valencia Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet Budapest Hungary
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Budapest Retina Associates Budapest Hungary
Oftalmika Sp. z o.o. Bydgoszcz Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
15.10.2024
Hungary Hungary
Not recruiting
15.10.2024
Italy Italy
Not recruiting
15.10.2024
Poland Poland
Not recruiting
15.10.2024
Spain Spain
Not recruiting
15.10.2024

Trial locations

Investigated drugs:

BI 764524 is a medication being tested in this clinical trial for its effects on diabetic retinopathy, a condition that affects the eyes of people with diabetes. This medication is given as an injection directly into the eye. The goal of using BI 764524 is to see if it can help improve the condition of the retina by reducing the severity of diabetic retinopathy. Researchers are studying how often the medication should be given to achieve the best results, and they are looking at how well patients’ eye conditions improve over time with this treatment.

Investigated diseases:

Diabetic retinopathy – Diabetic retinopathy is a complication of diabetes that affects the eyes. It occurs when high blood sugar levels cause damage to the blood vessels in the retina, the light-sensitive tissue at the back of the eye. In the early stages, there may be no symptoms, but as the condition progresses, it can lead to vision problems. The disease can advance to more severe forms, such as proliferative diabetic retinopathy, where new, abnormal blood vessels grow on the retina. These new vessels can leak blood and cause scar tissue, leading to further vision impairment. Over time, diabetic retinopathy can result in significant vision loss if not managed properly.

Trial ID:
2023-508891-12-00
Protocol code:
1436-0007
Trial Phase:
Therapeutic exploratory (Phase II)

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