1485-0018 (THULITE) - BI 1815368 in Diabetic Macular Oedema (DMO)
Research type
Research Study
Full title
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)
IRAS ID
1012274
Contact name
CT Disclosure & Data Transparency
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing a new medication, BI 1815368 (study drug), to help improved vision in people with centre-involved diabetic macular oedema (CI-DMO).
Diabetic macular oedema (DMO) is a serious complication of diabetic retinopathy (DR) that affects individuals with diabetes mellitus. DMO occurs when high blood sugar levels damage blood vessels in the retina, a thin layer of tissue at the back of the eye. The retina is important for vision; it converts light into signals sent to the brain, allowing us to see. When these blood vessels are damaged, they leak fluid into the macula, the central part of the retina responsible for sharp vision. This leads to blurred or distorted vision. CI-DMO is a specific type of DMO that affects the central part of the macula.
The purpose of this Phase 2 trial is to learn more about using 3 different amounts (dosage) of the trial medication (BI 1815368) by measuring any changes in vision that trial participants experience and seeing how safe it is.
The trial medication is a tablet that is taken by mouth twice a day: 2 tablets every morning and 2 tablets every evening at the same time every day, with or without a glass of water and with or without food.
People who join this study will grouped in two cohorts (cohort 1 and 2) based on their eye thickness and vision levels and depending on whether they have received certain eye injections in the past (called anti-VEGF treatments). In Cohort 1, participants will be assigned by chance to take either placebo or the study drug. After 100 people in Cohort 1 have joined, Cohort 2 will begin. Participants will be assigned by change to one of four groups receiving one of the following: placebo, the study drug at 20mg (once a day), study drug at 80 mg (once a day), and at 80 mg (twice a day).
Approximately 300 people will take part globally.
Both Cohorts 1 and 2 consist of Screening period (up to 28 days), Treatment period (up to 48 weeks), and a follow-up period (up to 4 weeks).REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0503
Date of REC Opinion
25 Jul 2025
REC opinion
Further Information Favourable Opinion