A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema

Launched by BOEHRINGER INGELHEIM · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new medicine called BI 1815368 to see if it can help improve vision for adults with a specific eye condition known as center-involved diabetic macular edema (CI-DME). To join the study, participants must be 18 or older, have diabetes, and their eye condition must meet certain criteria. This means that their eye has a specific amount of swelling that affects their vision.

The study lasts about a year and involves taking either BI 1815368 or a placebo (which looks like the real medicine but has no active ingredients) twice daily for around 11 months. Participants will visit the study site 16 times during this period for vision checks and eye examinations. This is a chance for individuals with CI-DME to explore potential new treatment options while contributing to important research that could benefit others in the future.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • ≥18 years of age
• • Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) \<12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline
• • Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal thickness (CST) ≥320 µm for male and ≥305 µm for female participants in the study eye at screening
• • Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening Further inclusion criteria apply.
• Exclusion criteria:
• • Macular edema considered to be due to other causes than CI-DME in the study eye
• • Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
• • Any intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than Vabysmo® or Eylea® HD), and within 6 months before Day 1 for Vabysmo® or Eylea® HD, and/or more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye
• • Any history of panretinal photocoagulation treatment, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of Iluvien® or Ozurdex® implants before Day 1, or topical steroid or NSAID treatment (within 30 days before Day 1)
• • Active ocular inflammation of any history of intraocular inflammation within 1 year
• • Aphakia or total absence of the posterior capsule; Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1 Further exclusion criteria apply.