BI 1815368 for Macular Edema

Recruiting at 8 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults over 18 with diabetic macular edema, specifically centre-involved diabetic macular edema (CI-DME), can join this study. They must have a certain thickness in their retina and controlled diabetes with no major medication changes planned. Good enough vision is required but not perfect.

Inclusion Criteria

I have diabetes with HbA1c below 12% and stable medication for 30 days.

My eye condition involves swelling in the center of the retina, confirmed by a special eye scan.

My vision in the study eye ranges from 20/320 to 20/32.

Treatment Details

Interventions

• BI 1815368

Trial Overview The trial tests if BI 1815368 improves sight for CI-DME patients. It has two parts: one compares the drug to a placebo, and the other tests different doses of BI 1815368 against a placebo. Participants take tablets twice daily for about 11 months and are monitored for a year.

Participant Groups

Group I: Cohort 2: Treatment arm, medium dose Experimental Treatment 1 Intervention

Group II: Cohort 2: Treatment arm, low dose Experimental Treatment 1 Intervention

Group III: Cohort 2: Treatment arm, high dose Experimental Treatment 1 Intervention

Group IV: Cohort 1: Treatment arm Experimental Treatment 1 Intervention

Group V: Cohort 1: Placebo arm Placebo Group 1 Intervention

Group VI: Cohort 2: Placebo arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+