A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated

Recruiting Phase 1 Phase 2 Interventional Study
Diabetic Macular Edema
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
49 (estimated)
Sponsor
Boehringer Ingelheim · Industry
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About This Trial
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 3…
Trial Locations
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Eligibility Criteria
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…
Contacts

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

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