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Monoclonal Antibodies

BI 764524 for Diabetic Retinopathy

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at week 52

Summary

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.

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.

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

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I am 18 years old or older.

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I have diabetes and my HbA1c is below 12%.

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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:

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I have new blood vessels in the front part of my eye.

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My eye exam shows new, abnormal blood vessels in my retina.

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I have had PRP treatment for my eyes.

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My eye condition involves swelling with a thickness of at least 320μm (men)/305μm (women).

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I have had eye injections for NPDR or DME within the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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