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Monoclonal Antibodies

BI 764524 for Diabetic Retinopathy

Phase 2
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years at time of signing Informed Consent Form
Diagnosis of DM under regular treatment with Haemoglobin A1c (HbA1c) <12%
Must not have
Evidence of active NV of the iris or in the anterior chamber angle
Evidence of active retinal neovascularisation (NV) on clinical exam and/or ultra-widefield colour fundus photography (UWF-CFP) within the ETDRS 7-field, confirmed by the CRC grading
Screening 3 weeks
Treatment Varies
Follow Up up to 72 weeks
Awards & highlights


This trial is open to adults with moderate or high severity non-proliferative diabetic retinopathy. The purpose of the study is to see if a medicine called BI 764524 can help people

Who is the study for?
Adults with moderate to severe non-proliferative diabetic retinopathy can join this study. They must have diabetes under control (HbA1c <12%), clear eyes, and good enough vision (20/100 or better). People are excluded if they don't meet these eye health and diabetes management criteria.Check my eligibility
What is being tested?
The trial is testing BI 764524 for diabetic retinopathy. Participants are randomly assigned to one of five groups: three receive varying numbers of BI 764524 injections, one receives sham injections, and the last group (US only) gets Aflibercept or sham treatments.See study design
What are the potential side effects?
Potential side effects aren't specified here but may include typical injection-related reactions such as eye irritation, discomfort, redness, or infection. Systemic side effects could also occur depending on the medication's profile.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 18 years old or older.
I have diabetes and my HbA1c is below 12%.
My eye condition is in the moderate to severe stage due to diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I have new blood vessels in the front part of my eye.
My eye exam shows new, abnormal blood vessels in my retina.
I have had PRP treatment for my eyes.
My eye condition involves swelling with a thickness of at least 320μm (men)/305μm (women).
I have had eye injections for NPDR or DME within the last 6 months.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Secondary outcome measures
Absolute change from baseline of best corrected visual acuity (BCVA) [early treatment diabetic retinopathy study (ETDRS) letters] in the study eye at Week 52
Absolute change from baseline of central retinal thickness [μm], as assessed by spectral domain optical coherence tomography (SD-OCT), in the study eye at Week 52
Occurrence of a ≥2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and Week 52
+6 more

Side effects data

From 2023 Phase 1 & 2 trial • 45 Patients • NCT04424290
Oedema peripheral
Ocular hyperaemia
Blood glucose decreased
Intraocular pressure increased
Conjunctival haemorrhage
Study treatment Arm
Single-rising Dose Part - Low Dose BI 764524
Multiple Dosing Part - High Dose BI 764524
Single-rising Dose Part - High Dose BI 764524
Multiple Dosing Part - Sham
Single-rising Dose Part - Medium Dose BI 764524

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: BI 764524Experimental Treatment1 Intervention
BI 764524
Group II: Aflibercept (Eylea®) - US onlyActive Control1 Intervention
Aflibercept (Eylea®) - US only
Group III: Sham comparator to BI 764524Placebo Group1 Intervention
Sham comparator to BI 764524
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 764524
Completed Phase 2

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,516 Previous Clinical Trials
11,347,168 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
230 Patients Enrolled for Diabetic Retinopathy
~119 spots leftby Jul 2026