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Study identifier: NCT07553429 Synced from ClinicalTrials.gov · July 28, 2026
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A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated

Condition: Diabetic Macular Edema  ·  Sponsor: Boehringer Ingelheim

PhasePhase 1/Phase 2
Planned participants49
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Boehringer Ingelheim  ·  1-800-243-0127  ·  clintriage.rdg@boehringer-ingelheim.com

Always discuss trial participation with your own doctor first.

Locations (30)

Associated Retina Consultants, Ltd.Phoenix, Arizona, United StatesNot Yet Recruiting
Research Network ArizonaScottsdale, Arizona, United StatesRecruiting
Win RetinaArcadia, California, United StatesRecruiting
Retina-Vitreous Associates Medical GroupBeverly Hills, California, United StatesNot Yet Recruiting
Global Research ManagementGlendale, California, United StatesRecruiting
Retina Associates of Southern CaliforniaHuntington Beach, California, United StatesNot Yet Recruiting
California Retina Consultants-Oxnard-70187Oxnard, California, United StatesNot Yet Recruiting
Retinal Consultants Medical GroupSacramento, California, United StatesNot Yet Recruiting
Bay Area Retina Associates - Walnut CreekWalnut Creek, California, United StatesRecruiting
Retina Group of New England, PCWaterford, Connecticut, United StatesNot Yet Recruiting
Retina Group of Florida - Fort Myers Retina CenterFort Myers, Florida, United StatesRecruiting
Florida Retina ConsultantsLakeland, Florida, United StatesRecruiting

+ 18 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07553429