A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema

Conditions

• Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BI 1815368 — DRUG
  BI 1815368
• Placebo — DRUG
  Placebo matching BI 1815368

Study Details

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.

Key Dates

Start date

Jun 5, 2025

Status verified

Jun 2026

Primary completion

Sep 1, 2027

Completion

Sep 29, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Treatment arm
• Placebo Comparator: Cohort 1: Placebo arm
• Placebo Comparator: Cohort 2: Placebo arm
• Experimental: Cohort 2: Treatment arm, low dose
• Experimental: Cohort 2: Treatment arm, medium dose
• Experimental: Cohort 2: Treatment arm, high dose

Primary Outcome Measure

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 ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (23)

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