A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment
Status:
Recruiting
Trial end date:
2023-02-17
Target enrollment:
Participant gender:
Summary
This study is open to adults with diabetic macular ischemia who have received laser
treatment. The main purpose of this study is to find out whether people with diabetic macular
ischemia can tolerate a medicine called BI 765128.
In this study, BI 765128 is given to people for the first time.
The study has 2 parts. Part A tests 3 doses of BI 765128. Participants get either a low,
medium or high dose of BI 765128 as a single injection into the eye. If participants tolerate
it well, the highest dose will be used in part B.
In part B, participants are put into 2 groups randomly, which means by chance. 1 group gets
BI 765128 as injection into the eye. The other group gets sham injections. A sham injection
means that it is not a real injection and contains no medicine. Participants cannot tell
whether they get the real injection or a sham injection. In this part, participants receive
study treatment once every month for 3 months.
Participants in part A are in the study for about 4 months and visit the study site about 8
times.
Participants in part B are in the study for about 5 months and visit the study site about 7
times.
The doctors regularly check participants' health and take note of any unwanted effects.