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

EU CTIS

Registry ID

CTIS2024-520384-14-00

Acronym

1485-0018

Enrollment

193

Registered

2025-09-30

Start date

2025-11-20

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Centre-involved diabetic macular edema

Brief summary

Occurrence (yes/no) of a gain of ≥10 ETDRS letters compared with baseline in the study eye at Week 48

Detailed description

Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48, Occurrence (yes/no) of drug-related AEs over the treatment period through EoS, Absolute change from baseline of CST as measured by SD-OCT in the study eye at Week 48

Interventions

DRUGBI 1815368 Placebo

DRUGBI 1815368

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence (yes/no) of a gain of ≥10 ETDRS letters compared with baseline in the study eye at Week 48	—

Secondary

Measure	Time frame
Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48, Occurrence (yes/no) of drug-related AEs over the treatment period through EoS, Absolute change from baseline of CST as measured by SD-OCT in the study eye at Week 48	—

Countries

Czechia, Germany, Hungary, Poland, Slovakia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026