Actively Recruiting
A First-in-human Study to Evaluate Safety and Tolerability of Multiple Intravitreal Doses of BI 3812465 in Adults With Center-involved Diabetic Macular Edema
Led by Boehringer Ingelheim · Updated on 2026-06-03
49
Participants Needed
30
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well different doses of a medicine called BI 3812465 are tolerated by adults with diabetic macular edema that affects the center of the eye. This is the first time BI 3812465 is given to humans. The study is designed in two parts an initial phase with a small group receiving increasing doses and a second phase with a larger group randomized to low, medium, or high doses. Participants receive BI 3812465 as injections into the back of the eye, with a total of three eye injections administered. In Part 1, participants start with low doses and may move to higher doses if tolerated. In Part 2, participants are randomly assigned to one of three dose groups. The study follows participants for up to seven months, including the dosing and observation periods. During the study, participants visit the study site 19 times, with some visits possibly conducted at home when feasible. At these visits, doctors assess the severity of the eye condition and monitor any health problems that may be caused by the medicine. The main outcomes include monitoring for dose-limiting events and ocular adverse events over up to 169 days from the first drug administration.
CONDITIONS
Brief Title
A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of diabetes mellitus type 1 or type 2 under regular treatment with HbA1c less than 12%
- Center-involved diabetic macular edema confirmed by retinal imaging with central subfield thickness of 320 micrometers or more
- Clear enough ocular media and good pupil dilation for quality eye imaging
- Willingness and ability to understand study procedures and risks
- Signed informed consent prior to any study procedures
- Women of childbearing potential must use highly effective birth control
- Men must use contraception or abstain to prevent pregnancy of a partner
You will not qualify if you...
- Only one functional eye; the other eye must support daily functioning
- Active proliferative diabetic retinopathy
- Active retinal neovascularization requiring acute treatment
- Active neovascularization of the iris or anterior chamber angle (except small iris tufts)
- Additional eye diseases that may affect study participation such as uncontrolled glaucoma or high intraocular pressure over 24 mmHg despite treatment
- History of high myopia greater than 8 diopters in the study eye
- Eye abnormalities that prevent adequate detection of inflammation or other pathologies
- Previous ocular gene or cell therapy
- Use of corticosteroids locally or systemically within 1 month before screening
- Absence of the posterior capsule (aphakia) or recent YAG laser capsulotomy within 2 months
- Other conditions that might interfere with study outcomes as judged by the investigator
Research Team
B
Boehringer Ingelheim
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