BI 764524 for Diabetic Retinopathy

Recruiting at 38 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Boehringer Ingelheim

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

Disqualifiers: Retinal neovascularisation, CI-DME, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

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.

What makes the drug BI 764524 unique for treating diabetic retinopathy?

The drug BI 764524 is unique for treating diabetic retinopathy because it represents a novel approach compared to traditional treatments like anti-vascular endothelial growth factor drugs and corticosteroids, which focus on retinal vascular abnormalities. However, specific details about its mechanism of action or administration are not provided in the available research. ^{1 2 3 4 5}

Eligibility Criteria

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 am 18 years old or older.

I have diabetes and my HbA1c is below 12%.

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.

Trial Timeline

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

Treatment Details

Interventions

• BI 764524 (Monoclonal Antibodies)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Germany 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. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Emerging Insights and Interventions for Diabetic Retinopathy. [2021]

3. Japan 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Diabetic retinopathy. [2007]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Pathophysiology of Diabetic Retinopathy: The Old and the New. [2023]