A First-in Human Trial to Study Safety and Tolerability of Single Rising Intravitreal dOses (Open Label, Non-randomized, Uncontrolled) and in Addition the Early Biological Response of Multiple intravitReal Dosing (Single-masked, raNdomized, Sham-controlled) of BI 764524 in panretinaL Photocoagulation (PRP) Treated proLiferative Diabetic Retinopathy (PDR) Patients With Diabetic Macular Ischemia (DMI) - the HORNBILL Study (HORNBILL)
This is a study in people with a type of diabetic eye disease called diabetic retinopathy
with diabetic macular ischemia. People who have had laser treatment for their diabetic
retinopathy can participate in the study. The laser treatment is called panretinal
The purpose of the study is to find out how well different doses of a medicine called BI
764524 are tolerated. BI 764524 is injected into the eye. The study has 2 parts. In the first
part, participants get different doses of BI 764524 only once. Participants are in the first
part for about 5 months and visit the study site about 8 times. In the second part,
participants are put into different groups by chance. Some participants get BI 764524
injections every 4 weeks. Other participants get sham injections every 4 weeks. 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. For the second part,
participants are in the study for about 7 months. During this time, they visit the study site
about 7 times. In this study, BI 764524 is given to humans for the first time.
The doctors compare how well people tolerate the BI 764524 injections and the sham
The doctors also regularly check the general health of the participants.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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