First Human Study to Evaluate Safety and Tolerance of Different Doses of BI 3812465 Injected Into the Eye for Adults With Center-Involved Diabetic Macular Edema

What this Trial Is About

Researchers are evaluating how well different doses of a medicine called BI 3812465 are tolerated in adults with diabetic macular edema that affects the center of the eye. This is the first time BI 3812465 is being given to humans. The study is a Phase IIIa trial conducted in two parts to investigate safety and tolerability of this treatment. In Part 1, a small group of participants receive low, medium, or high doses of BI 3812465 as injections into the back of the eye. Participants starting later receive higher doses only if lower doses are tolerated. In Part 2, a larger group is randomized into low, medium, or high dose groups, also receiving three eye injections of BI 3812465. The treatment is given sequentially with dose escalation based on safety. Participants stay in the study for up to seven months, attending 19 visits to the study site, with some visits possibly conducted at home. During these visits, doctors assess the severity of the eye condition and monitor any health problems related to the treatment. The study measures safety outcomes including dose limiting events and ocular adverse events over up to 169 days after treatment starts.

A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated