BI 764524 for Diabetic Retinopathy

Recruiting at 115 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: Steroids, Anti-VEGF, others

Disqualifiers: Retinal neovascularisation, CI-DME, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 52 weeks

178 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 764524, to determine its effectiveness for diabetic retinopathy, a condition affecting the eyes of people with diabetes. Researchers randomly divide participants into five groups: three groups receive varying numbers of BI 764524 injections in one eye over a year, while the other groups receive a placebo injection or a drug called aflibercept. The trial aims to identify the best treatment plan and assess whether BI 764524 improves eye health. It targets adults with moderate to severe diabetic retinopathy who have eye damage but no active severe complications. Participants will regularly visit the study site for eye exams and overall health check-ups to monitor changes or side effects. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in diabetic retinopathy care.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that certain past treatments for diabetic retinopathy in the study eye may affect eligibility, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BI 764524 is generally safe for humans. In earlier studies, researchers tested this medication on individuals with diabetic macular ischemia, a condition linked to diabetic retinopathy. These studies found that BI 764524 was safe when administered as eye injections, whether as a single dose or multiple doses. The treatment met its main safety goals, indicating that most participants did not experience serious side effects. This suggests that BI 764524 might also be safe for individuals with diabetic retinopathy. However, the current study aims to further explore its safety for this specific condition. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for diabetic retinopathy focus on inhibiting VEGF, a protein that can cause abnormal blood vessel growth, with drugs like Aflibercept (Eylea®) being common. But BI 764524 stands out because it targets a different pathway, potentially offering a new mechanism of action that goes beyond just blocking VEGF. Researchers are excited because BI 764524 could provide an alternative for patients who don't respond well to current treatments, offering hope for more effective management of diabetic retinopathy.

What evidence suggests that this trial's treatments could be effective for diabetic retinopathy?

Research has shown that BI 764524, a treatment under study in this trial, might help treat conditions like diabetic retinopathy, an eye problem caused by diabetes. BI 764524 targets a protein called Sema3A, which is involved in eye issues, making it promising for eye health. In earlier studies, patients tolerated BI 764524 well, and it showed positive results for diabetic macular ischemia, another eye condition. These findings suggest that BI 764524 could help manage eye problems caused by diabetic retinopathy. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My eyes can be clearly imaged for a fundus exam.

I have diabetes and my HbA1c is below 12%.

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 screening

Exclusion Criteria

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

Refractive error of more than -8 dioptres of myopia in the study eye

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 764524 or sham injections over 1 year, with regular eye exams and visual tests

52 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 764524

Trial Overview 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.

How Is the Trial Designed?

Group I: BI 764524 Experimental Treatment 1 Intervention

BI 764524

Group II: Aflibercept (Eylea®) - US only Active Control 1 Intervention

Aflibercept (Eylea®) - US only

Group III: Sham comparator to BI 764524 Placebo Group 1 Intervention

Sham comparator to BI 764524

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

Diabetic retinopathy is a major cause of blindness in the western world, highlighting the urgent need for improved methods of diagnosis and treatment.

Research at Aarhus University Hospital focuses on key areas such as epidemiology, computerized grading, and understanding the disease's underlying mechanisms to enhance visual outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetic retinopathy: a review of the aarhus approach to studies on epidemiology, computerised grading, and the pathophysiology of the disease. Bek, T.[2009]

In a study of 3841 diabetic patients, 29.8% were found to have diabetic retinopathy, with 4.6% having the more severe proliferative type, highlighting the prevalence of this complication among diabetics.

Among the patients, 7.2% had severely weakened visual acuity, with 4.0% of these cases attributed to diabetic retinopathy, indicating a significant impact of this condition on vision in diabetic individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of severely impaired visual acuity among diabetic patients in Fukuoka Prefecture with special emphasis on diabetic retinopathy: a survey by the Fukuoka Diabetes Clinic Group. Kido, Y., Hososako, A.[2019]

Recent advances in retinal imaging have revealed that retinal damage from diabetes can occur before visible symptoms of diabetic retinopathy appear, allowing for earlier intervention in high-risk patients.

Current treatments, including vascular endothelial growth factor antagonists, effectively reduce vision loss and new therapies are being developed to address both vascular and neural aspects of diabetic retinopathy, highlighting its complex nature beyond just blood vessel damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Insights and Interventions for Diabetic Retinopathy. Honasoge, A., Nudleman, E., Smith, M., et al.[2021]

Recent advancements in imaging and pharmacological treatments, such as anti-VEGF drugs and corticosteroids, have significantly improved the management of diabetic retinopathy (DR), which is primarily caused by retinal vascular issues.

Non-diabetic mouse models have been crucial in revealing the underlying mechanisms of DR, such as pericyte deficiency and retinal ischemia, which could lead to new drug developments targeting the breakdown of the blood-retina barrier and retinal neovascularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathophysiology of Diabetic Retinopathy: The Old and the New. Kusuhara, S., Fukushima, Y., Ogura, S., et al.[2023]

Maintaining good glycemic control can significantly reduce the risk of developing diabetic retinopathy and help prevent vision loss in individuals with diabetes, as supported by recent studies and clinical trials.

Timely photocoagulation treatment for severe cases of diabetic retinopathy, such as proliferative retinopathy or macular edema, has been shown to effectively prevent vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetic retinopathy. Klein, R.[2007]

Citations

1. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/positive-results-diabetic-macular-ischemia-treatment

Positive results Diabetic Macular Ischemia treatment The study found that BI 764524 was well tolerated following intravitreal administration of single and multiple doses, meeting its primary safety endpoints.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04424290

HORNBILL: A Study to Test Different Doses of BI 764524 in ... The purpose of the study is to find out how well different doses of a medicine called BI 764524 are tolerated.

3. sciencedirect.com sciencedirect.com/science/article/pii/S266691452500079X

HORNBILL: A First-in-Human Phase I/IIa Study of the ... Twelve participants received single IVT doses of BI 764524 0.5 mg (n = 3), 1.0 mg (n = 3), or 2.5 mg (n = 6) in the SRD part.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9386971/

HORNBILL: a phase I/IIa trial examining the safety, tolerability ... BI 764524, an anti-Sema3A agent, may be an effective treatment for retinal ischaemia. Sema3A modulation is a promising mechanism of action that ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06321302

NCT06321302 | A Study to Test Whether BI 764524 Helps ... 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40655321/

HORNBILL: A First-in-Human Phase I/IIa Study of the ... HORNBILL: A First-in-Human Phase I/IIa Study of the Safety, Tolerability, and Early Pharmacodynamics of BI 764524 for Diabetic Macular Ischemia.