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.
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.
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.
Only one functional eye, even if that eye was otherwise eligible for the study. Fellow eye must have sufficient visual function per the investigator's medical judgment in consultation with the participant, to support the participant's daily functioning.
Evidence of active proliferative diabetic retinopathy (PDR).
Evidence of active retinal neovascularization (NV) clinical exam and/or Ultra-Widefield Color Fundus Photography ((UWF-)CFP) within the early treatment diabetic retinopathy study (ETDRS) 7-field, confirmed by the CRC grading. Potential participants with NV outside of the ETDRS 7-field on ultra-widefield imaging may be included in the trial if this condition, based on the assessment of the investigator, does not require acute treatment.
Evidence of active NV of the iris (small iris tufts are not an exclusion) or in the anterior chamber angle.
Sequential
Low dose BI 3812465
Biological/VaccineBI 3812465
Medium dose BI 3812465
Biological/VaccineBI 3812465
High dose BI 3812465
Biological/VaccineBI 3812465
6
Treatment groupsSee each treatment group below.
Part 1: Occurrence of dose limiting events (DLEs) from first investigational medicine product (IMP) administration until end of study (EOS)
Part 2: Occurrence of ocular adverse events (AEs) in the study eye from first IMP administration until EOS
Occurrence of AEs from first IMP administration until EOS
Occurrence of serious adverse events (SAEs) from first IMP administration until EOS
Part 1: Occurrence of ocular AEs in the study eye from first IMP administration until EOS
Click on the lead sponsor to view all of their trials.
