A First-in-human, Open-label (Part 1), Randomized (Part 2), Phase I/IIa Trial to Study Safety and Tolerability of Multiple Rising Intravitreal Doses of BI 3812465 in Patients With Center-involved Diabetic Macular Edema
This study is open to adults with diabetic macular edema that involves the center of the eye. The purpose of this study is to find out how well different doses of a medicine called BI 3812465 are tolerated by people with this condition. This is the first time BI 3812465 is given to humans. This study has 2 parts. In Part 1, a small number of participants receive low, medium, or high doses of BI 3812465. The first participants to start the study get low doses of BI 3812465. Participants who start later get higher doses only if the lower doses were tolerated. In Part 2, a larger number of participants are placed into low, medium, or high dose groups. Participants in both parts of the study get BI 3812465 as injections into the back of the eye for a total of 3 eye injections. Participants are in the study for up to 7 months. During this time, they visit the study site 19 times. Where possible, some visits can be done at the participant's home instead of the study site. At study visits, the doctors check the severity of participants' eye condition and note any health problems that could have been caused by BI 3812465.
∙ All participants, study eye:
• Center-involved diabetic macular edema (CI-DME) defined as CST ≥320 μm (micrometers) at Screening, as confirmed on spectral-domain optical coherence tomography (SD-OCT) and confirmed by the central reading center (CRC).
• Sufficiently clear ocular media, adequate pupillary dilation, and fixation, to permit quality fundus imaging.
∙ All participants:
• Diagnosis of diabetes mellitus (DM) type 1 or type 2 under regular treatment, with glycated hemoglobin HbA1c \<12%.
• Be willing and able to understand the study procedures and the risks involved.
• Signed and dated written informed consent in accordance with international council for harmonization - good clinical practices (ICH-GCP) and local legislation prior to admission to the trial and any trial related procedures.
• Age ≥18 years (or above legal age according to local legislation) at time of signing the informed consent form (ICF).
• Male or female participants
‣ Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control
⁃ For men, contraception (condom or complete abstinence) should be used as precaution to prevent pregnancy of a partner and/or exposure of an existing embryo or fetus.
∙ Further inclusion criteria apply.