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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250338

Enrollment

300

Registered

2025-09-04

Start date

2025-12-18

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Interventions

BI 1815368 Placebo matching BI 1815368

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - >=18 years of age - Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) =320 um 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

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.

Design outcomes

Primary

Measure	Time frame
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 [Time Frame: at baseline, 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.	—

Countries

China, Czech Republic, Germany, Hungary, Japan, Poland, Slovakia, UK, US

Contacts

Public ContactjRCT Inquiry Receipt Center IQVIA Services Japan G.K.

IQVIA Services Japan G.K.

1485-0018_japan_jrct@iqvia.com+81-3-6859-9500

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jun 11, 2026