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

Launched by BOEHRINGER INGELHEIM · Mar 14, 2024

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ClinConnect Summary

This clinical trial is investigating whether a new medicine called BI 764524 can help adults with a serious eye condition known as diabetic retinopathy. This condition affects people with diabetes and can lead to vision problems. To participate in the study, individuals must be 18 years or older, have moderate to severe non-proliferative diabetic retinopathy, and meet certain health criteria. Participants will be randomly placed into different groups, where some will receive injections of BI 764524 into one eye, while others may receive a placebo (a treatment that looks like the real medicine but has no active ingredients) to compare results.

Over the course of the study, which lasts about one and a half years, participants will visit the study site at least 16 times for eye exams and health check-ups. After one year of treatment, researchers will evaluate how many participants show improvement in their eye condition. This trial is important because it could lead to new treatment options for people suffering from diabetic retinopathy, helping to preserve their vision and enhance their quality of life. If you're interested in learning more or seeing if you qualify, please talk to your healthcare provider.

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ALL

Eligibility criteria

• • General inclusion criteria
• • Diagnosis of DM under regular treatment with Haemoglobin A1c (HbA1c) (glycated haemoglobin) (HbA1c) \<12%
• • Age ≥18 years at time of signing Informed Consent Form
• • Ocular inclusion criteria: study eye
• • Moderately severe to severe non-proliferative diabetic retinopathy (NPDR) (Diabetic Retinopathy Severity Scale (DRSS) 47 to 53) based on early treatment diabetic retinopathy study (ETDRS) 7-field grading as confirmed by the central reading centre (CRC) at screening
• • Presence of retinal non-perfusion (RNP) as assessed by ultra-widefield fluorescein angiography (UWF-FA) defined as an area ≥12.5 square millimeter (mm²) (approximately ≥5 disc areas) within a circular area with a 17.5 millimeter (mm) radius centred to the fovea as confirmed by the CRC at screening
• • 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
• • Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging
• Main exclusion criteria in study eye:
• • 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
• • -- Neovascularisations outside of the ETDRS 7-field on ultra-widefield imaging may be included if this condition, based on the assessment of the investigator, does not require acute treatment
• • Evidence of active NV of the iris (small iris tufts are not an exclusion) or in the anterior chamber angle
• • Prior pan-retinal photocoagulation (PRP) (defined as ≥100 burns placed previously outside of the posterior pole)
• • CI-DME, defined as a central subfield thickness (CST) ≥320 micrometer (μm) (men)/305 μm (women), measured by Heidelberg Spectralis optical coherence tomography (OCT)), in the study eye as confirmed by the CRC at screening
• • Previous treatment in the study eye for NPDR and/or diabetic macular edema (DME) with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) (including anti-VEGF/Ang2) drugs within 6 months prior to Day 1. The number of patients with history of an IVT anti-VEGF treatment is limited to approximately 50 randomised patients. Once this number has been achieved, any patients with previous IVT treatment will be excluded
• • Any previous IVT treatment other than anti-VEGF, including steroids
• • Refractive error of more than -8 dioptres of myopia (spherical equivalent) in the study eye. For patients having undergone refractive or cataract surgery in the study eye, the preoperative refractive error should be used.
• * Any concurrent or past ocular condition in the study eye which, in the judgement of the investigator, could:
• • Require medical or surgical intervention during the study period to prevent or treat vision loss (e.g. advanced cataract, history of retinal detachment or macular hole (Stage 3 or 4) in the study eye)
• • Could likely contribute to a significant loss of BCVA during the study period if left untreated (e.g. advanced epiretinal membrane and/or vitreomacular traction, active or history of optic neuritis in either eye)
• • Contraindicate the use of the investigational drug, or may render the patient at high risk for treatment complications (e.g. active infectious or non-infectious conjunctivitis/keratitis in either eye; history of recurrent infectious or inflammatory ocular disease in either eye (e.g. uveitis)
• • May affect interpretation of the study results (e.g. central atrophy of the retinal pigment epithelium or photoreceptors; age-related macular degeneration, hereditary retinal degenerative diseases, myopic macular degeneration, past, current or planned use of medications known to be toxic to the retina, lens or optic nerve (e.g. deferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol); history of central serous chorioretinopathy, ischemic optic neuropathy or retinal vascular occlusion