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Clinical Trials in the UK / NCT06962839
Recruiting Phase 2

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

NCT06962839 · tracked via the Priya Life Science UK tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 2
Started
2025-06-05
Last updated
2026-09-03

Condition(s) studied

Macular Edema

Investigational drug(s) / intervention(s)

BI 1815368Placebo

BI 1815368: BI 1815368

Placebo: Placebo matching BI 1815368

Study summary

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 months.

Participants are in the study for about 1 year. During this time, they visit the study site 16 times. At visits, doctors check the participant's vision and collect information on any health problems. They take detailed pictures of the eye. The changes over time are compared between the groups to see if the treatment works.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 * Any intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than faricimab or aflibercept 8mg), and within 6 months before Day 1 for faricimab or aflibercept 8 mg, and/or more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye * Any history of panretinal photocoagulation, macular laser 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 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.

Primary outcome measure(s)

Trial sites (97)

FacilityCityRegionStatus
Arizona Retina & Vitreous Research, Central Phoenix Phoenix Arizona Not Yet Recruiting
Win Retina Arcadia California Recruiting
Retina Associates of Southern California Huntington Beach California Recruiting
Retinal Consultants Medical Group, Inc Modesto California Recruiting
Eye Research Foundation Newport Beach California Not Yet Recruiting
Doheny Eye Center UCLA Arcadia Pasadena California Recruiting
Retina Consultants of San Diego Poway California Recruiting
West Coast Retina Medical Group, Inc. San Francisco California Recruiting
Colorado Retina Associates Lakewood Colorado Recruiting
Connecticut Eye Consultants, PC Danbury Connecticut Not Yet Recruiting
Retina Group of Florida - Fort Lauderdale Retina Center Fort Lauderdale Florida Not Yet Recruiting
Florida Retina Institute, Jacksonville Southside Jacksonville Florida Not Yet Recruiting
Advanced Research Institute Pompano Beach Florida Recruiting
Retina Vitreous Associates of Florida St. Petersburg Florida Not Yet Recruiting
East Florida Eye Institute Stuart Florida Not Yet Recruiting
Center for Retina and Macular Disease Winter Haven Florida Recruiting
Southeast Retina Center, PC Augusta Georgia Not Yet Recruiting
Associated Vitreoretinal and Uveitis Consultants Carmel Indiana Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Cumberland Valley Retina Consultants Hagerstown Maryland Recruiting
Sierra Eye Associates Reno Nevada Recruiting
North Carolina Retina Associates Wake Forest North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Verum Research, LLC Eugene Oregon Recruiting
Retina Consultants of Carolina, P.A. Greenville South Carolina Not Yet Recruiting
Tennessee Retina Nashville Tennessee Recruiting
Austin Research Center for Retina, PLLC Austin Texas Recruiting
Austin Retina Associates Austin Texas Recruiting
Austin Retina Associates Austin Texas Not Yet Recruiting
Austin Clinical Research, LLC Austin Texas Recruiting
Retina Consultants of Texas - Beaumont Beaumont Texas Not Yet Recruiting
Texas Retina Associates Dallas Texas Recruiting
Medical Center Ophthalmology Associates San Antonio Texas Not Yet Recruiting
Retinal Consultants of San Antonio San Antonio Texas Not Yet Recruiting
Retina Center Of Texas Southlake Texas Recruiting
Retina Consultants of Texas The Woodlands Texas Recruiting
Piedmont Eye Center Lynchburg Virginia Not Yet Recruiting
Retina Consultants, PLLC Charleston West Virginia Not Yet Recruiting
West China Hospital, Sichuan University Chengdu China Recruiting
Shanghai General Hospital Shanghai China Recruiting

+ 57 more sites — see the full list on the official registry below.

More Boehringer Ingelheim trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06962839 on ClinicalTrials.gov ↗ ← All trials in the UK