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

ClinicalTrials.gov ID: NCT07553429

Public ClinicalTrials.gov record NCT07553429. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 23, 2026, 1:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A First-in-human, Open-label (Part 1), Randomized (Part 2), Phase I/IIa Trial to Study Safety and Tolerability of Multiple Rising Intravitreal Doses of BI 3812465 in Patients With Center-involved Diabetic Macular Edema

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07553429
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Boehringer Ingelheim; Industry
Enrollment: 49 participants

Conditions and interventions

Conditions

Diabetic Macular Edema

Interventions

Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 14, 2026 (Actual)
Primary completion: Mar 23, 2027 (Estimated)
Completion: Jul 6, 2027 (Estimated)
Last update posted: Oct 14, 2026

2026 – 2027

United States locations

U.S. sites: 28
U.S. states: 12
U.S. cities: 27

Facility	City	State	ZIP	Site status
Associated Retina Consultants, Ltd.	Phoenix	Arizona	85020	Recruiting
Research Network Arizona	Scottsdale	Arizona	85255	Recruiting
Win Retina	Arcadia	California	91006	Recruiting
Retina-Vitreous Associates Medical Group	Beverly Hills	California	90211	Recruiting
Global Research Management	Glendale	California	91204	Recruiting
Retina Associates of Southern California	Huntington Beach	California	92647	Not yet recruiting
California Retina Consultants-Oxnard-70187	Oxnard	California	93036	Recruiting
Retinal Consultants Medical Group	Sacramento	California	95825	Recruiting
Bay Area Retina Associates - Walnut Creek	Walnut Creek	California	94598	Recruiting
Retina Group of New England, PC	Waterford	Connecticut	06385	Recruiting
Retina Group of Florida - Fort Myers Retina Center	Fort Myers	Florida	33912	Recruiting
Florida Retina Consultants	Lakeland	Florida	33805	Recruiting
East Florida Eye Institute	Stuart	Florida	34994	Recruiting
Ophthalmic Consultants of Long Island	Oceanside	New York	11572	Recruiting
North Carolina Retina Associates	Wake Forest	North Carolina	27587	Recruiting
Red River Research Partners, LLC	Fargo	North Dakota	58103	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Not yet recruiting
Verum Research, LLC	Eugene	Oregon	97401	Recruiting
EyeHealth Northwest	Portland	Oregon	97225	Recruiting
Tennessee Retina	Nashville	Tennessee	37203	Recruiting
Austin Clinical Research, LLC	Austin	Texas	78750	Recruiting
Retina Consultants of Texas-Bellaire-67493	Bellaire	Texas	77401	Recruiting
Valley Retina Institute, PA	McAllen	Texas	78503	Recruiting
Medical Center Ophthalmology Associates	San Antonio	Texas	78240	Recruiting
Retina Consultants of Texas	San Antonio	Texas	78240	Recruiting
Retina Consultants of Texas-The Woodlands-67575	The Woodlands	Texas	77384	Not yet recruiting
Strategic Clinical Research Group	Willow Park	Texas	76087	Recruiting
Emerson Clinical Research Institute	Falls Church	Virginia	22042	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07553429, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 14, 2026 · Synced Oct 23, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07553429 live on ClinicalTrials.gov.

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