NCT06321302 · Boehringer Ingelheim
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
What this study is about
This study is open to adults with diabetic retinopathy. People who have non-proliferative diabetic retinopathy of moderate or high severity can join the study. The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy. The study also aims to find a suitable treatment plan for BI 764524. Participants are put into 5 groups by chance.
View original scientific description
This study is open to adults with diabetic retinopathy. People who have non-proliferative diabetic retinopathy of moderate or high severity can join the study. The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy. The study also aims to find a suitable treatment plan for BI 764524. Participants are put into 5 groups by chance. Participants in groups 1, 2, and 3 get BI 764524.
Interventions
DRUG
BI 764524
BI 764524
DRUG
Sham comparator to BI 764524
Sham comparator to BI 764524
DRUG
Aflibercept (Eylea®) - US only
Aflibercept (Eylea®) - US only
Primary outcome measures
Occurrence of a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52 as assessed by Ultra-widefield colour fundus photography (UWF-CFP) images (within the 7-field grid)
Time frame: At baseline and at Week 52
The DRSS is a scale which can take on the following discrete values: 10, 20, 35, 43, 47, 53, 61, 65, 71, 75, 81, 85. Here 10 means "No retinopathy" and 85 means "Advanced proliferative diabetic retinopathy, with posterior fundus obscured, or centre of macula detached". Thus, a higher score means symptoms get worse.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of DM under regular treatment with Haemoglobin A1c (HbA1c) (glycated haemoglobin) (HbA1c) \<12%
- Age ≥18 years at time of signing Informed Consent Form Ocular inclusion criteria: study eye
- Moderately severe to severe non-proliferative diabetic retinopathy (NPDR) (Diabetic Retinopathy Severity Scale (DRSS) 47 to 53) based on early treatment diabetic retinopathy study (ETDRS) 7-field grading as confirmed by the central reading centre (CRC) at screening
- Presence of retinal non-perfusion (RNP) as assessed by ultra-widefield fluorescein angiography (UWF-FA) defined as an area ≥12.5 square millimeter (mm²) (approximately ≥5 disc areas) within a circular area with a 17.5 millimeter (mm) radius centred to the fovea as confirmed by the CRC at screening
- Visual acuity: best corrected visual acuity (BCVA) letter score of ≥49 letters (approximate Snellen equivalent of 20/100 or better) using ETDRS chart at starting distance of 4 meter (m) at screenin
Where
- Phoenix, Arizona
- Bakersfield, California
- Beverly Hills, California
- Campbell, California
- Encino, California
- Glendale, California
- Huntington Beach, California
- Palo Alto, California
- Pasadena, California
- Sacramento, California
- Santa Maria, California
- Walnut Creek, California
And 24 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2026 · Source of record for eligibility and locations