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

RecruitingPhase 2Ages 18 Years - anyAllBoehringer Ingelheim
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In plain words

What the trial is, and whether it could suit you

This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose. This study has 2 parts. In the first part, participants are put into 2 groups of equal size randomly, which means by chance. One group takes BI 1815368 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1815368 tablets but do not contain any medicine. In the second part, participants are put into 4 groups of equal size randomly. 3 groups take different daily doses of the study medicine, BI 1815368, while 1 group takes placebo. All participants take tablets twice a day for about 11

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • BI 1815368
  • Placebo
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Where

97 sites
Arizona Retina & Vitreous Research, Central Phoenix
Phoenix, United States
Win Retina
Arcadia, United States
Retina Associates of Southern California
Huntington Beach, United States
Retinal Consultants Medical Group, Inc
Modesto, United States
Eye Research Foundation
Newport Beach, United States
Doheny Eye Center UCLA Arcadia
Pasadena, United States
Retina Consultants of San Diego
Poway, United States
West Coast Retina Medical Group, Inc.
San Francisco, United States

…and 89 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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