A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy

Phase 2

Recruiting

• Conditions: Diabetic Retinopathy
• Interventions: Drug: BI 764524; Drug: Aflibercept (Eylea®) - US only; Drug: Sham comparator to BI 764524

• Registration Number: NCT06321302
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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. Over 1 year, they get a different number of injections of the same dose of BI 764524 injected into 1 eye. During some visits, participants may get a sham control, which is done like an eye injection but without a needle, so that participants will not know how many injections of BI 764524 they received. Participants in group 4 only get a sham control. Participants in group 5 (only in the USA) get aflibercept or sham injections during some visits. Aflibercept is a medicine already used to treat diabetic retinopathy.

Participants are in the study for one and a half years. During this time, they visit the study site at least 16 times. During this time, doctors regularly do eye exams and visual tests to assess the severity of participants' eye condition. After 1 year of treatment, researchers look at the number of participants with eye improvements. To do so, they compare eye damage and certain severe eye problems between the groups of participants. The doctors also regularly check participants' health and take note of any unwanted effects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-20
• Study Start: 2024-05-15
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-22
• Last Update Posted: 2025-08-24
• Primary Completion: 2026-07-01
• Study Completion: 2026-11-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 764524	BI 764524	BI 764524
Aflibercept (Eylea®) - US only	Aflibercept (Eylea®) - US only	Aflibercept (Eylea®) - US only
Sham comparator to BI 764524	Sham comparator to BI 764524	Sham comparator to BI 764524

Primary Outcome Measures

Name	Time	Method
Occurrence of a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52	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.

Secondary Outcome Measures

Name	Time	Method
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	At baseline and at Week 52	μm= micrometer
Occurrence of proliferative diabetic retinopathy (PDR) and/or anterior segment neovascularisation (NV) in the study eye between baseline and Week 52	At baseline and at Week 52
Occurrence of vision threatening complications (VTC)s in the study eye between baseline and Week 52	At baseline and at Week 52
Absolute change from baseline of best corrected visual acuity (BCVA) [early treatment diabetic retinopathy study (ETDRS) letters] in the study eye at Week 52	At baseline and at Week 52	The BCVA score is the number of letters read correctly by the patient.
Occurrence of centre-involved diabetic macular edema (CI-DME) in the study eye between baseline and Week 52	At baseline and at Week 52
Occurrence of ocular AEs in the study eye between baseline and EOS	up to 72 weeks
Occurrence of ocular AEs of special interest in the study eye between baseline and EOS	up to 72 weeks
Occurrence of a ≥2-step worsening of Diabetic Retinopathy Severity Scale (DRSS) in the study eye between baseline and Week 52	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.
Occurrence of drug-related adverse events (AEs) between baseline and end of study (EOS)	up to 72 weeks

Trial Locations

Locations (85)

Associated Retina Consultants, Ltd.; 🇺🇸 Phoenix, Arizona, United States

California Retina Consultants-Bakersfield-65523; 🇺🇸 Bakersfield, California, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Retinal Diagnostic Center; 🇺🇸 Campbell, California, United States

The Retina Partners; 🇺🇸 Encino, California, United States

Lugene Eye Institute; 🇺🇸 Glendale, California, United States

Retina Associates of Southern California; 🇺🇸 Huntington Beach, California, United States

Byers Eye Institute; 🇺🇸 Palo Alto, California, United States

California Eye Specialists Medical Group Inc; 🇺🇸 Pasadena, California, United States

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

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