Tests BI 1815368 tablets in people with diabetic macular edema
Tests whether a tablet medicine helps adults with a diabetes-related eye condition.
Plain-language title generated from the registry record
Registry title: A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
Key facts
- Where
- Budapest, Budapest XIII, Debrecen, Pécs, Szeged, and Szombathely, HungarySee the 9 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diabetes who have centre-involved diabetic macular edema, an eye problem with swelling in the centre of the retina. It tests a tablet called BI 1815368 against placebo.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Centre-involved diabetic macular edema in the study eye, confirmed by an eye scan (SD-OCT) with central subfield thickness of at least 320 µm. Vision (ETDRS letter score) between 24 and 78 in the study eye.
- Earlier treatment
- Diabetes must be treated with stable medication for at least 30 days before Day 1. No anti-VEGF eye injection in the study eye within 8 weeks before Day 1 (16 weeks for faricimab or aflibercept 8 mg). No eye steroid treatment within 12 months before Day 1.
- Biomarker or test result
- HbA1c below 12% (108 mmol/mol).
Main reasons for not taking part
- Macular edema caused by something other than diabetes in the study eye
- Proliferative diabetic retinopathy or new vessels on the iris in the study eye
- Past panretinal photocoagulation or vitreoretinal surgery
- Active eye inflammation, or eye inflammation within 1 year
- Aphakia or total absence of the posterior capsule in the study eye
Read by machine on 12 November 2026.
Where in Hungary
- Budapesti Bajcsy-Zsilinszky Korhaz Es RendelointezetBudapest, HungaryTaking people
- Budapesti Jahn Ferenc Del-pesti Korhaz es RendelointezetBudapest, HungaryTaking people
- Eszak-Pesti Centrumkórház-HonvédkórházBudapest, HungaryTaking people
- Budapest Retina Associates Kft.Budapest XIII, HungaryTaking people
- University of DebrecenDebrecen, HungaryTaking people
- Ganglion Orvosi KözpontPécs, HungaryTaking people
- University of PecsPécs, HungaryTaking people
- University of SzegedSzeged, HungaryTaking people
- Vas Varmegyei Markusovszky Egyetemi OktatokorhazSzombathely, HungaryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT06962839EU 2024-520384-14-00
- Record updated
- 12 November 2026
- Original 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.Read full original descriptionShow less
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)
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.
Inclusion: ≥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: 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; 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; Active ocular inflammation or any history of intraocular inflammation within 1 year; 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.