A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
A Randomised, Double-masked, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral BI 1815368 in Participants With Centre-involved Diabetic Macular Edema for 48 Weeks of Treatment (THULITE)
3 other identifiers
interventional
300
9 countries
80
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2025
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 8, 2025
CompletedStudy Start
First participant enrolled
June 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 29, 2027
July 9, 2026
July 1, 2026
2.2 years
April 30, 2025
July 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence (yes/no) of a gain of ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with baseline in the study eye at Week 48
With ETDRS letters, the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters is measured.
at baseline, at week 48
Secondary Outcomes (3)
Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48
at baseline, at week 48
Occurrence (yes/no) of drug-related adverse events (AEs) over the treatment period through end of study (EoS)
up to 52 weeks
Absolute change from baseline of central subfield foveal thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) in the study eye at Week 48
at baseline, at week 48
Study Arms (6)
Cohort 1: Treatment arm
EXPERIMENTALCohort 1: Placebo arm
PLACEBO COMPARATORCohort 2: Placebo arm
PLACEBO COMPARATORCohort 2: Treatment arm, low dose
EXPERIMENTALCohort 2: Treatment arm, medium dose
EXPERIMENTALCohort 2: Treatment arm, high dose
EXPERIMENTALInterventions
BI 1815368
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
Win Retina
Arcadia, California, 91006, United States
Retina Associates of Southern California
Huntington Beach, California, 92647, United States
Retinal Consultants Medical Group, Inc
Modesto, California, 95356, United States
Doheny Eye Center UCLA Arcadia
Pasadena, California, 91103, United States
Retina Consultants of San Diego
Poway, California, 92064, United States
West Coast Retina Medical Group, Inc.
San Francisco, California, 94109, United States
Colorado Retina Associates
Lakewood, Colorado, 80228, United States
Advanced Research Institute
Pompano Beach, Florida, 33064, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Associated Vitreoretinal and Uveitis Consultants
Carmel, Indiana, 46032, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Verum Research, LLC
Eugene, Oregon, 97401, United States
Tennessee Retina
Nashville, Tennessee, 37203, United States
Austin Research Center for Retina, PLLC
Austin, Texas, 78705, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Austin Clinical Research, LLC
Austin, Texas, 78750, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Center Of Texas
Southlake, Texas, 76092, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
West China Hospital, Sichuan University
Chengdu, 610041, China
Shanghai General Hospital
Shanghai, 200080, China
The Fourth People's Hospital of Shenyang
Shenyang, 110031, China
Shijiazhuang People's Hospital
Shijiazhuang, 050011, China
Shanxi Eye Hospital
Taiyuan, 030072, China
University Hospital Hradec Kralove (FNHK)
Hradec Králové, 500 03, Czechia
University Hospital Ostrava
Ostrava-Poruba, 708 52, Czechia
Oftex s.r.o.
Pardubice, 530 02, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 00, Czechia
Fakultni Thomayerova nemocnice
Prague, 140 59, Czechia
Axon Clinical s.r.o.
Prague, 150 00, Czechia
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, 68167, Germany
Augenzentrum am St. Franziskus-Hospital Münster
Münster, 48145, Germany
Central Hospital of Northern Pest - Military Hospital
Budapest, 1068, Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106, Hungary
Budapest Retina Associations Kft.
Budapest, 1133, Hungary
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204, Hungary
University of Debrecen
Debrecen, 4032, Hungary
Nozologen Kft.
Pécs, 7621, Hungary
University of Pecs
Pécs, 7623, Hungary
University of Szeged
Szeged, 6720, Hungary
Asahikawa Medical University Hospital
Asahikawa-shi, 078-8510, Japan
Tokyo Medical University Hachioji Medical Center
Hachioji-shi, 193-0998, Japan
Kagawa University Hospital
Kita-gun, 761-0793, Japan
Kurume University Hospital
Kurume-shi, 830-0011, Japan
Shinshu University Hospital
Matsumoto-shi, 390-8621, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, 152-8902, Japan
Nagoya City University Hospital
Nagayoga, 467-8602, Japan
Tokyo Women's Medical University Hospital
Tokyo, 162-8666, Japan
Juntendo University Urayasu Hospital
Urayasu-shi, 279-0021, Japan
Szpital Swietego Lukasza S. A.
Bielsko-Biala, 43-309, Poland
Oculomedica Sp. z o.o.
Bydgoszcz, 85-157, Poland
Clinical Medical Research Sp. z o.o.
Katowice, 40-156, Poland
Szpital Sw. Rozy Sp. z o.o.
Krakow, 30-394, Poland
Centrum Medyczne Dietla 19 Sp. z o.o.
Krakow, 31-070, Poland
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
Olsztyn, 10-424, Poland
Poznanskie Centrum Wzroku sp z o o
Poznan, 60-538, Poland
Caminomed Sp. z o.o.
Tarnowskie Góry, 42-600, Poland
Eb Group Sp. z o.o.
Warsaw, 00-189, Poland
Warszawski Szpital Okulistyczny Sp. z o.o.
Warsaw, 01-258, Poland
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, 974 01, Slovakia
Nemocnica s poliklinikou Trebisov a.s.
Trebišov, 075 01, Slovakia
Fakultna nemocnica Trencin
Trenčín, 911 01, Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, 101 01, Slovakia
Frimley Park Hospital
Camberley, GU16 7UJ, United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN, United Kingdom
Northwick Park Hospital
Harrow, HA1 3UJ, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
Moorfields Eye Hospital
London, EC1V 2PD, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
Southend University Hospital
Westcliff-on-Sea, SS0 0RY, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 8, 2025
Study Start
June 5, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 29, 2027
Last Updated
July 9, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.