RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Boehringer Ingelheim • ClinicalTrials.gov ID: NCT06962839

Registry updated: 2026-10-16

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Description

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 at least 16 times. Participants taking metformin have 3 additional study visits. 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.

Interventions

BI 1815368 (Drug)
BI 1815368
Placebo (Drug)
Placebo matching BI 1815368

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 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.

Conditions

Macular Edema

Locations

Arizona Retina & Vitreous Research, Central Phoenix — Phoenix, Arizona, United States
Win Retina — Arcadia, California, United States
Retina Associates of Southern California — Huntington Beach, California, United States
Retinal Consultants Medical Group, Inc — Modesto, California, United States
Eye Research Foundation — Newport Beach, California, United States
Doheny Eye Center UCLA Arcadia — Pasadena, California, United States
Retina Consultants of San Diego — Poway, California, United States
West Coast Retina Medical Group, Inc. — San Francisco, California, United States
Colorado Retina Associates — Lakewood, Colorado, United States
Connecticut Eye Consultants, PC — Danbury, Connecticut, United States
Retina Group of Florida - Fort Lauderdale Retina Center — Fort Lauderdale, Florida, United States
Florida Retina Institute, Jacksonville Southside — Jacksonville, Florida, United States
Advanced Research Institute — Pompano Beach, Florida, United States
East Florida Eye Institute — Stuart, Florida, United States
Center for Retina and Macular Disease — Winter Haven, Florida, United States
Southeast Retina Center, PC — Augusta, Georgia, United States
Associated Vitreoretinal and Uveitis Consultants — Carmel, Indiana, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
Sierra Eye Associates — Reno, Nevada, United States
North Carolina Retina Associates — Wake Forest, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
Verum Research, LLC — Eugene, Oregon, United States
Retina Consultants of Carolina, P.A. — Greenville, South Carolina, United States
Tennessee Retina — Nashville, Tennessee, United States
Austin Research Center for Retina, PLLC — Austin, Texas, United States
Austin Retina Associates — Austin, Texas, United States
Austin Retina Associates — Austin, Texas, United States
Austin Clinical Research, LLC — Austin, Texas, United States
Retina Consultants of Texas - Beaumont — Beaumont, Texas, United States
Texas Retina Associates — Dallas, Texas, United States
Medical Center Ophthalmology Associates — San Antonio, Texas, United States
Retinal Consultants of San Antonio — San Antonio, Texas, United States
Retina Center Of Texas — Southlake, Texas, United States
Retina Consultants of Texas — The Woodlands, Texas, United States
Piedmont Eye Center — Lynchburg, Virginia, United States
Retina Consultants, PLLC — Charleston, West Virginia, United States
West China Hospital, Sichuan University — Chengdu, China
Shanghai General Hospital — Shanghai, China
The Fourth People's Hospital of Shenyang — Shenyang, China
Shijiazhuang People's Hospital — Shijiazhuang, China
Shanxi Eye Hospital — Taiyuan, China
University Hospital Hradec Kralove (FNHK) — Hradec Králové, Czechia
University Hospital Ostrava — Ostrava-Poruba, Czechia
Oftex s.r.o. — Pardubice, Czechia
Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia
Vseobecna Fakultni Nemocnice V Praze — Prague, Czechia
Fakultni Thomayerova nemocnice — Prague, Czechia
Axon Clinical s.r.o. — Prague, Czechia
Universitaetsklinikum Carl Gustav Carus TU Dresden — Dresden, Germany
Universitätsklinikum Düsseldorf — Düsseldorf, Germany
Universitätsklinikum Leipzig — Leipzig, Germany
Universitätsklinikum Mannheim GmbH — Mannheim, Germany
Augenzentrum am St. Franziskus-Hospital Münster — Münster, Germany
Central Hospital of Northern Pest - Military Hospital — Budapest, Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet — Budapest, Hungary
Budapest Retina Associations Kft. — Budapest, Hungary
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet — Budapest, Hungary
University of Debrecen — Debrecen, Hungary
Nozologen Kft. — Pécs, Hungary
University of Pecs — Pécs, Hungary
University of Szeged — Szeged, Hungary
Asahikawa Medical University Hospital — Asahikawa-shi, Japan
Chofu Eye Clinic — Chofu-shi, Japan
Tokyo Medical University Hachioji Medical Center — Hachioji-shi, Japan
Tokiwadai Muranaka Eye Clinic — Itabashi-ku, Japan
Kagawa University Hospital — Kita-gun, Japan
Kurume University Hospital — Kurume-shi, Japan
Shinshu University Hospital — Matsumoto-shi, Japan
National Hospital Organization Tokyo Medical Center — Meguro-ku, Japan
Nagoya City University Hospital — Nagayoga, Japan
Musashi Dream Eye Clinic — Osaka, Japan
Tokyo Women's Medical University Hospital — Tokyo, Japan
Juntendo University Urayasu Hospital — Urayasu-shi, Japan
Szpital Swietego Lukasza S. A. — Bielsko-Biala, Poland
Oculomedica Sp. z o.o. — Bydgoszcz, Poland
Clinical Medical Research Sp. z o.o. — Katowice, Poland
Szpital Sw. Rozy Sp. z o.o. — Krakow, Poland
Centrum Medyczne Dietla 19 Sp. z o.o. — Krakow, Poland
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o. — Olsztyn, Poland
Poznanskie Centrum Wzroku sp z o o — Poznan, Poland
Caminomed Sp. z o.o. — Tarnowskie Góry, Poland
Eb Group Sp. z o.o. — Warsaw, Poland
Warszawski Szpital Okulistyczny Sp. z o.o. — Warsaw, Poland
F D Roosevelt University General Hospital Of Banska Bystrica — Banská Bystrica, Slovakia
Nemocnica s poliklinikou Trebisov a.s. — Trebišov, Slovakia
Fakultna nemocnica Trencin — Trenčín, Slovakia
Fakultna nemocnica s poliklinikou Zilina — Žilina, Slovakia
Frimley Park Hospital — Camberley, United Kingdom
Gloucestershire Royal Hospital — Gloucester, United Kingdom
Northwick Park Hospital — Harrow, United Kingdom
Royal Liverpool University Hospital — Liverpool, United Kingdom
Moorfields Eye Hospital — London, United Kingdom
King's College Hospital — London, United Kingdom
Royal Victoria Infirmary — Newcastle upon Tyne, United Kingdom
Sunderland Eye Infirmary — Sunderland, United Kingdom
Southend University Hospital — Westcliff-on-Sea, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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