BI 764524 for Diabetic Retinopathy
Recruiting in Palo Alto (17 mi)
+38 other locations
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.
12345Eligibility 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%.
+3 more
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.
+4 more
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
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Associated Retina Consultants, Ltd.Phoenix, AZ
Retina Associates of Southern CaliforniaHuntington Beach, CA
California Eye Specialists Medical Group IncPasadena, CA
NJRetinaTeaneck, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Boehringer IngelheimLead Sponsor
References
Diabetic retinopathy: a review of the aarhus approach to studies on epidemiology, computerised grading, and the pathophysiology of the disease. [2009]Diabetic retinopathy is one of the leading causes of blindness in the western world (Munier et al 1998). The challenges for improving the visual prognosis in this disease are comprehensive, and involve a multitude of methodological approaches. Thus, ongoing research programmes are aimed at studying as diverse aspects of diabetic retinopathy as epidemiology, genetics, screening, diagnosis, treatment, and understanding of the pathophysiology of the disease. This review presents the scientific approach followed at Aarhus University Hospital in relation to three of these aspects-epidemiology, computerised grading, and elucidation of the pathophysiology of diabetic retinopathy.
Emerging Insights and Interventions for Diabetic Retinopathy. [2021]To introduce recent advances in the understanding of diabetic retinopathy and to summarize current and emerging strategies to treat this common and complex cause of vision loss.
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]From December 1981 to January 1982, 3841 diabetic patients were seen in 16 diabetic clinics in Fukuoka Prefecture. Among them, 3289 diabetics had been examined for the presence of ophthalmological complications during the past year, and 979 cases (29.8%) had diabetic retinopathy, in which the proliferative type manifested itself in 152 cases (4.6%). Of 3841 diabetics in our clinics, there were 275 cases (7.2%) with severely weakened visual acuity (assessed by corrected acuity below 0.1), of which 153 cases (4.0%) resulted from diabetic retinopathy. Of these, 92 (2.4% of total diabetics) had visual defects in both eyes. Analyses on these 153 cases revealed several features, i.e., there were 10 cases with maculopathy and 4 cases with secondary rubeotic glaucoma, the age of the patients was 55.9 +/- 11.5 (mean +/- S.D.) years, and the presumed duration of diabetes, time lapse until appearance of visual defect(s) from onset of diabetes and the untreated period were 13.8 +/- 6.6 (n = 150), 10.5 +/- 6.0 (n = 124) and 4.2 +/- 4.9 (n = 101) years, respectively.
Diabetic retinopathy. [2007]Diabetic retinopathy is a leading cause of loss of vision in the United States. Results of recent population-based studies and randomized controlled clinical trials suggest that glycemic control can lower the incidence and prevent the progression of retinopathy and loss of vision associated with diabetes. In addition, data from clinical trials showed that timely photocoagulation treatment of severe proliferative retinopathy or clinically significant macular edema prevents loss of vision. This report reviews the epidemiology of diabetic retinopathy and highlights areas in need of further epidemiologic research.
Pathophysiology of Diabetic Retinopathy: The Old and the New. [2023]Vision loss in diabetic retinopathy (DR) is ascribed primarily to retinal vascular abnormalities-including hyperpermeability, hypoperfusion, and neoangiogenesis-that eventually lead to anatomical and functional alterations in retinal neurons and glial cells. Recent advances in retinal imaging systems using optical coherence tomography technologies and pharmacological treatments using anti-vascular endothelial growth factor drugs and corticosteroids have revolutionized the clinical management of DR. However, the cellular and molecular mechanisms underlying the pathophysiology of DR are not fully determined, largely because hyperglycemic animal models only reproduce limited aspects of subclinical and early DR. Conversely, non-diabetic mouse models that represent the hallmark vascular disorders in DR, such as pericyte deficiency and retinal ischemia, have provided clues toward an understanding of the sequential events that are responsible for vision-impairing conditions. In this review, we summarize the clinical manifestations and treatment modalities of DR, discuss current and emerging concepts with regard to the pathophysiology of DR, and introduce perspectives on the development of new drugs, emphasizing the breakdown of the blood-retina barrier and retinal neovascularization.