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NCT07553429 · ClinicalTrials.gov registry record · Phase 1
A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT07553429 is a Phase 1 study that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 49 participants.
The verdict
NCT07553429, a Phase 1 study, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Low dose BI 3812465
- BIOLOGICAL Medium dose BI 3812465
- BIOLOGICAL High dose BI 3812465
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2026-05-14 |
| Est. Completion | 2027-07-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07553429
The ClinicalTrials.gov registry entry for NCT07553429 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Low dose BI 3812465 is the first listed.
NCT07553429 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07553429 about?
NCT07553429 is a clinical study titled "A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated". 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 stu...
What is the current status of trial NCT07553429?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2026-05-14. Estimated completion is 2027-07-06.
What interventions are being tested in trial NCT07553429?
The interventions under investigation include: Low dose BI 3812465 (BIOLOGICAL), Medium dose BI 3812465 (BIOLOGICAL), High dose BI 3812465 (BIOLOGICAL).
Who is sponsoring clinical trial NCT07553429?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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