BI 1815368 for centre-involved diabetic macular edema.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with centre-involved diabetic macular edema confirmed by SD-OCT and meeting visual acuity and diabetes control criteria are enrolled for about one year. The trial has two randomized parts: Part 1 randomizes participants 1:1 to BI 1815368 or matching placebo, and Part 2 randomizes participants 1:1:1:1 to three different daily doses of BI 1815368 or placebo. All participants take tablets twice daily for roughly 11 months while undergoing scheduled eye exams and imaging to track vision and retinal thickness. The main goals are to see if BI 1815368 improves sight and to identify the most suitable dose.

Why it matters

Who can join: the full rules

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 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
* Intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment in the study eye is not allowed within 8 weeks prior to Day 1, except for faricimab or aflibercept 8 mg, for which a 16-week washout period prior to Day 1 is required. There is no limit on the total number of prior IVT antiVEGF injections, provided that the subject has demonstrated a response to prior antiVEGF treatment (at the investigator's discretion) and the anatomical integrity is confirmed by the central reading centre (CRC) at screening based on spectral domain optical coherence tomography (SD-OCT).
* Any history of panretinal photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of fluocinolone ophthalmic implant or dexamethasone IVT implant before Day 1, or topical steroid or nonsteroidal anti-inflammatory drug (NSAID) treatment (within 30 days before Day 1)
* Prior macular laser photocoagulation performed more than 3 months prior to Day 1 is permitted if absence of scar-like changes within the 1-mm diameter region centred on the fovea is confirmed by the CRC at screening based on SD-OCT
* Active ocular inflammation or 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.

Where it's running

• Win Retina
  Arcadia, California, United States Recruiting
• Retina Associates of Southern California
  Huntington Beach, California, United States Recruiting
• Retinal Consultants Medical Group, Inc
  Modesto, California, United States Recruiting
• Doheny Eye Center UCLA Arcadia
  Pasadena, California, United States Recruiting
• Retina Consultants of San Diego
  Poway, California, United States Recruiting
• West Coast Retina Medical Group, Inc.
  San Francisco, California, United States Recruiting

+47 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.