Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Fast replyInvestigationalNo 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 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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

3 criteria

  • 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.
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

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

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.

What is already known about the treatment

BI 764524 – BI 764524 is administered through an injection directly into the eye, a method known as intravitreal injection. It is currently being studied in clinical trials for its potential use in treating diabetic retinopathy, a condition that affects the blood vessels in the retina of people with diabetes. The medication works by targeting specific pathways at the molecular level to help reduce the severity of the disease. It is classified as an investigational drug, meaning it is still under research and not yet approved for general medical use.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508891-12-00Protocol code1436-0007Estimated enrolment216 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can 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.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).