Clinical trial • Phase II • Ophthalmology
BI 1815368 for Diabetic macular edema
Phase II trial of BI 1815368 for Diabetic macular edema.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Diabetic macular edema
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-06-2025
- First CTIS Authorization Date
- 30-09-2025
Trial design
Randomised, bi 1815368 placebo (placebo comparator). dose and schedule not specified in the part i data available.-controlled Phase II trial in Czechia, Germany, Hungary and others.
- Randomised
- Yes
- Comparator
- BI 1815368 Placebo (placebo comparator). Dose and schedule not specified in the Part I data available.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 107
- Trial Duration For Participant
- 336
Eligibility
Recruits 107 No vulnerable population selected (isVulnerablePopulationSelected:false). Participants must be adults (≥18 years). Subject information and informed consent forms (L1/L2 documents) are provided for participating countries (multiple local language versions listed)..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected:false). Participants must be adults (≥18 years). Subject information and informed consent forms (L1/L2 documents) are provided for participating countries (multiple local language versions listed).
Inclusion criteria
- {"criterion_text":"- ≥18 years of age"}
- {"criterion_text":"- Diagnosis of diabetes mellitus (DM) (type 1 or type 2), 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"}
- {"criterion_text":"- CI-DME confirmed on SD-OCT with CST ≥320 µm for male and ≥305 µm for female participants in the study eye at screening"}
- {"criterion_text":"- BCVA visual acuity ETDRS letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening"}
- {"criterion_text":"- Further inclusion criteria apply"}
Exclusion criteria
- {"criterion_text":"- Macular edema considered to be due to other causes than CI-DME in the study eye"}
- {"criterion_text":"- Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye"}
- {"criterion_text":"- Any 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"}
- {"criterion_text":"- 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)"}
- {"criterion_text":"- Active ocular inflammation of any history of intraocular inflammation within 1 year"}
- {"criterion_text":"- Aphakia or total absence of the posterior capsule; YAG laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1"}
- {"criterion_text":"- Further exclusion criteria apply"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence (yes/no) of a gain of ≥10 ETDRS letters compared with baseline in the study eye at Week 48","definition_or_measurement_approach":"Measured as occurrence (yes/no) of gain ≥10 ETDRS letters from baseline in the study eye at Week 48 using ETDRS visual acuity testing."}
Secondary endpoints
- {"endpoint_text":"- Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48","definition_or_measurement_approach":"Measured as occurrence (yes/no) of gain ≥15 ETDRS letters from baseline in the study eye at Week 48 using ETDRS visual acuity testing."}
- {"endpoint_text":"- Occurrence (yes/no) of drug-related AEs over the treatment period through EoS","definition_or_measurement_approach":"Occurrence of adverse events assessed as drug-related between baseline and end of study (EoS) as reported and adjudicated per study safety reporting procedures."}
- {"endpoint_text":"- Absolute change from baseline of CST as measured by SD-OCT in the study eye at Week 48","definition_or_measurement_approach":"Change from baseline in central subfield foveal thickness (CST) measured by spectral domain optical coherence tomography (SD-OCT) in the study eye at Week 48."}
Recruitment
- Registry Or Advocacy Recruitment
- Yes
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 107
- Recruitment Window Months
- 23
- Consent Approach
- Informed consent is obtained using provided subject information sheets and informed consent forms (L1/L2 documents). Local-language ICFs and supporting materials are available for participating countries (documented versions for Czech, German, Hungarian, Polish, Slovak). Participants are adults (≥18) and provide their own consent; no assent is indicated.
Methods
- Doctor-to-patient letters (K2_Recruitment material_Doctor to Patient Letter) – channel: direct communication via treating physicians; target audience: patients with diabetic macular edema; country-specific materials available (e.g., DEU, CZE, POL versions).
- Patient pre-enrollment cards and Patient ID Cards (K2_Pre-enrollment card / L2_Patient ID Card) – channel: physical/print materials given in clinics; target audience: potential participants at study sites; country-specific versions present.
- Patient brochures, posters and flyers (K2_Recruitment material_Patient Brochure / Patient Poster / Patient Flyer) – channel: clinic/display and print distribution; target audience: patients and clinic visitors; country-specific versions available.
- Patient portal content (K2_Recruitment material_Patient Portal Content) – channel: online patient portal content; target audience: patients using clinic portals or trial portals; country-specific adaptations present.
- Patient advocacy group engagement (K2_Recruitment material_Patient Advocacy Group Letter) – channel: outreach via patient advocacy organisations; target audience: patient groups and advocates; country-specific versions exist.
- Community engagement slides (K2_ Recruitment material_D and I Community Engagement Slides / D_I Community Engagement Slides) – channel: presentations/engagement events; target audience: patient communities and stakeholders; country-specific slides available (e.g., DE, POL, CZE).
Geography
- Total Number Of Sites
- 35
- Total Number Of Participants
- 193
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-09-2025
- Latest Decision Or Authorization Date
- 01-10-2025
- Processing Time Days
- 15
- Number Of Sites
- 7
- Number Of Participants
- 39
Sites
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Ocni klinika
- Principal Investigator Name
- Jan Nemcansky
- Principal Investigator Email
- jan.nemcansky@fno.cz
- Contact Person Name
- Jan Nemcansky
- Contact Person Email
- jan.nemcansky@fno.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Ocni klinika
- Principal Investigator Name
- Miroslav Veith
- Principal Investigator Email
- mveith@email.cz
- Contact Person Name
- Miroslav Veith
- Contact Person Email
- mveith@email.cz
- Site Name
- Axon Clinical s.r.o.
- Department Name
- Ocni klinika
- Principal Investigator Name
- Jan Ernest
- Principal Investigator Email
- jan.ernest@axon-clinical.com
- Contact Person Name
- Jan Ernest
- Contact Person Email
- jan.ernest@axon-clinical.com
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Ocni klinika
- Principal Investigator Name
- Katerina Myslik Manethova
- Principal Investigator Email
- katerina.manethova@ftn.cz
- Contact Person Name
- Katerina Myslik Manethova
- Contact Person Email
- katerina.manethova@ftn.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Ocni klinika
- Principal Investigator Name
- Jan Beranek
- Principal Investigator Email
- jan.beranek1@fnhk.cz
- Contact Person Name
- Jan Beranek
- Contact Person Email
- jan.beranek1@fnhk.cz
- Site Name
- Oftex s.r.o.
- Department Name
- Ocni klinika
- Principal Investigator Name
- Vladimir Korda
- Principal Investigator Email
- korda@oftex.cz
- Contact Person Name
- Vladimir Korda
- Contact Person Email
- korda@oftex.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Ocni klinika
- Principal Investigator Name
- Bohdan Kousal
- Principal Investigator Email
- bohdan.kousal@vfn.cz
- Contact Person Name
- Bohdan Kousal
- Contact Person Email
- bohdan.kousal@vfn.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 15-08-2025
- Latest Decision Or Authorization Date
- 01-10-2025
- Processing Time Days
- 47
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Augenheilkunde
- Principal Investigator Name
- Ramin Khoramnia
- Principal Investigator Email
- ramin.khoramnia@ukdd.de
- Contact Person Name
- Ramin Khoramnia
- Contact Person Email
- ramin.khoramnia@ukdd.de
- Site Name
- Universitaet Leipzig
- Department Name
- Augenklinik
- Principal Investigator Name
- Focke Ziemssen
- Principal Investigator Email
- Focke.ziemssen@medizin.uni-leipzig.de
- Contact Person Name
- Focke Ziemssen
- Contact Person Email
- Focke.ziemssen@medizin.uni-leipzig.de
- Site Name
- Augenzentrum Am St Franziskus-Hospital Muenster
- Department Name
- Augenzentrum
- Principal Investigator Name
- Georg Spital
- Principal Investigator Email
- Georg.spital@augen-franziskus.de
- Contact Person Name
- Georg Spital
- Contact Person Email
- Georg.spital@augen-franziskus.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Augenheilkunde
- Principal Investigator Name
- Rainer Guthoff
- Principal Investigator Email
- Rainer.guthoff@med.uni-duesseldorf.de
- Contact Person Name
- Rainer Guthoff
- Contact Person Email
- Rainer.guthoff@med.uni-duesseldorf.de
- Site Name
- Heidelberg University (Mannheim site)
- Department Name
- Augenklinik
- Principal Investigator Name
- Robert Finger
- Principal Investigator Email
- robertpatrick.finger@umm.de
- Contact Person Name
- Robert Finger
- Contact Person Email
- robertpatrick.finger@umm.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 11-08-2025
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 53
- Number Of Sites
- 9
- Number Of Participants
- 30
Sites
- Site Name
- Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
- Department Name
- Szemészeti Osztály
- Principal Investigator Name
- Ágnes Kerényi
- Principal Investigator Email
- agneskerenyi@gmail.com
- Contact Person Name
- Ágnes Kerényi
- Contact Person Email
- agneskerenyi@gmail.com
- Site Name
- Budapest Retina Associates Kft.
- Department Name
- -
- Principal Investigator Name
- András Seres
- Principal Investigator Email
- seres@budapestretina.hu
- Contact Person Name
- András Seres
- Contact Person Email
- seres@budapestretina.hu
- Site Name
- University Of Pecs
- Department Name
- Szemeszeti Klinika
- Principal Investigator Name
- Adrienne Csuták
- Principal Investigator Email
- csutak.adrienne@pte.hu
- Contact Person Name
- Adrienne Csuták
- Contact Person Email
- csutak.adrienne@pte.hu
- Site Name
- University Of Debrecen
- Department Name
- Szemklinika
- Principal Investigator Name
- Attila Vajas
- Principal Investigator Email
- vajasa@gmail.com
- Contact Person Name
- Attila Vajas
- Contact Person Email
- vajasa@gmail.com
- Site Name
- Ganglion Orvosi Központ
- Department Name
- -
- Principal Investigator Name
- Balázs László Varsányi
- Principal Investigator Email
- varsanyi.balazs@ganglion.hu
- Contact Person Name
- Balázs László Varsányi
- Contact Person Email
- varsanyi.balazs@ganglion.hu
- Site Name
- University Of Szeged
- Department Name
- Szemészeti Klinika
- Principal Investigator Name
- Edit Tóth-Molnár
- Principal Investigator Email
- tme@tmedit.hu
- Contact Person Name
- Edit Tóth-Molnár
- Contact Person Email
- tme@tmedit.hu
- Site Name
- Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
- Department Name
- Szemészeti Osztály
- Principal Investigator Name
- György Bátor
- Principal Investigator Email
- bator.gyorgy@gmail.com
- Contact Person Name
- György Bátor
- Contact Person Email
- bator.gyorgy@gmail.com
- Site Name
- Észak-Pesti Centrumkórház-Honvédkórház
- Department Name
- Szemészeti Osztály
- Principal Investigator Name
- Gábor Vogt
- Principal Investigator Email
- gabor.vogt@tosho.hu
- Contact Person Name
- Gábor Vogt
- Contact Person Email
- gabor.vogt@tosho.hu
- Site Name
- Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
- Department Name
- Szemészeti Osztály
- Principal Investigator Name
- Norbert Czumbel
- Principal Investigator Email
- czumbel@gmail.com
- Contact Person Name
- Norbert Czumbel
- Contact Person Email
- czumbel@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 27-06-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 101
- Number Of Sites
- 10
- Number Of Participants
- 84
Sites
- Site Name
- Eb Group Sp. z o.o.
- Department Name
- Centrum Zdrowia MDM
- Principal Investigator Name
- Piotr Wnorowski
- Principal Investigator Email
- piotrwnorowski@gmail.com
- Contact Person Name
- Piotr Wnorowski
- Contact Person Email
- piotrwnorowski@gmail.com
- Site Name
- Szpital Sw. Rozy Sp. z o.o.
- Principal Investigator Name
- Małgorzata Siewierska
- Principal Investigator Email
- siewierskamalgorzata@swroza.pl
- Contact Person Name
- Małgorzata Siewierska
- Contact Person Email
- siewierskamalgorzata@swroza.pl
- Site Name
- Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.
- Principal Investigator Name
- Dominik Zalewski
- Principal Investigator Email
- domizal@gmail.com
- Contact Person Name
- Dominik Zalewski
- Contact Person Email
- domizal@gmail.com
- Site Name
- Centrum Medyczne Dietla 19 Sp. z o.o.
- Principal Investigator Name
- Piotr Oleksy
- Principal Investigator Email
- piotroleksy@yahoo.pl
- Contact Person Name
- Piotr Oleksy
- Contact Person Email
- piotroleksy@yahoo.pl
- Site Name
- Szpital Swietego Lukasza S.A.
- Principal Investigator Name
- Bogumił Wowra
- Principal Investigator Email
- bogumilwowra@gmail.com
- Contact Person Name
- Bogumił Wowra
- Contact Person Email
- bogumilwowra@gmail.com
- Site Name
- Poznanskie Centrum Wzroku Sp. z o.o.
- Principal Investigator Name
- Mikolaj Meller
- Principal Investigator Email
- mikolaj.meller@centrumwzroku.com
- Contact Person Name
- Mikolaj Meller
- Contact Person Email
- mikolaj.meller@centrumwzroku.com
- Site Name
- Clinical Medical Research Sp. z o.o.
- Principal Investigator Name
- Piotr Gościniewicz
- Principal Investigator Email
- piotr.gosciniewicz@clinicalmedicalresearch.pl
- Contact Person Name
- Piotr Gościniewicz
- Contact Person Email
- piotr.gosciniewicz@clinicalmedicalresearch.pl
- Site Name
- Warszawski Szpital Okulistyczny Sp. z o.o.
- Principal Investigator Name
- Agnieszka Nowosielska
- Principal Investigator Email
- nowosielska.aga@gmail.com
- Contact Person Name
- Agnieszka Nowosielska
- Contact Person Email
- nowosielska.aga@gmail.com
- Site Name
- Caminomed Sp. z o.o.
- Principal Investigator Name
- Barbara Zatorska
- Principal Investigator Email
- caminomed.zatorska@gmail.com
- Contact Person Name
- Barbara Zatorska
- Contact Person Email
- caminomed.zatorska@gmail.com
- Site Name
- Oculomedica Sp. z o.o.
- Principal Investigator Name
- Bartosz Sikorski
- Principal Investigator Email
- sikorski@doctors.org.uk
- Contact Person Name
- Bartosz Sikorski
- Contact Person Email
- sikorski@doctors.org.uk
Slovakia
- Earliest CTIS Part Ii Submission Date
- 24-09-2025
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 6
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Fakultna Nemocnica Trencín
- Department Name
- Ophthalmological clinic
- Principal Investigator Name
- Marek Kacerik
- Principal Investigator Email
- marekkacerik@gmail.com
- Contact Person Name
- Marek Kacerik
- Contact Person Email
- marekkacerik@gmail.com
- Site Name
- Fakultna Nemocnica S Poliklinikou Zilina
- Department Name
- Ophthalmology
- Principal Investigator Name
- Blandina Lipkova
- Principal Investigator Email
- blandina.lipkova@gmail.com
- Contact Person Name
- Blandina Lipkova
- Contact Person Email
- blandina.lipkova@gmail.com
- Site Name
- F D Roosevelt University General Hospital Of Banska Bystrica
- Department Name
- II. Eye clinic SZU
- Principal Investigator Name
- Ladislav Janco
- Principal Investigator Email
- ljanco@nspbb.sk
- Contact Person Name
- Ladislav Janco
- Contact Person Email
- ljanco@nspbb.sk
- Site Name
- Nemocnica S Poliklinikou Trebisov a.s.
- Department Name
- Ophthalmology
- Principal Investigator Name
- Maria Hurcikova
- Principal Investigator Email
- maria.hurcikova@svetzdravia.com
- Contact Person Name
- Maria Hurcikova
- Contact Person Email
- maria.hurcikova@svetzdravia.com
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Merit CRO Inc.
- Responsibilities
- Imaging Services
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"Training and certification of visual function examiners","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"Imaging Services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BI 1815368
- Active Substance
- BI 1815368
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Investigational Product Name
- BI 1815368 Placebo
- Modality
- Other
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