A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are … (NCT07553429) | Clinical Trial Compass
RecruitingPhase 1/2
A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated
United States, Puerto Rico49 participantsStarted 2026-05-14
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
Exclusion Criteria:
All participants, study eye:
* Only one functional eye, even if that eye was otherwise eligible for the study. Fellow eye must have sufficient visual function per the investi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Occurrence of dose limiting events (DLEs) from first investigational medicine product (IMP) administration until end of study (EOS)
Timeframe: Up to 169 days.
2
Part 2: Occurrence of ocular adverse events (AEs) in the study eye from first IMP administration until EOS