A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated
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.
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
Study identification
- NCT ID
- NCT07553429
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Boehringer Ingelheim
- Industry
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Interventions
- High dose BI 3812465 Biological
- Low dose BI 3812465 Biological
- Medium dose BI 3812465 Biological
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 13, 2026
- Primary completion
- Mar 22, 2027
- Completion
- Jul 5, 2027
- Last update posted
- Apr 27, 2026
2026 – 2027
United States locations
- U.S. sites
- 26
- U.S. states
- 11
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Associated Retina Consultants, Ltd. | Phoenix | Arizona | 85020 | — |
| Retina Macula Institute of Arizona | Scottsdale | Arizona | 85255 | — |
| Win Retina | Arcadia | California | 91006 | — |
| California Retina Consultants-Bakersfield-65523 | Bakersfield | California | 93309 | — |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | — |
| Global Research Management | Glendale | California | 91204 | — |
| Retinal Consultants Medical Group | Sacramento | California | 95825 | — |
| Bay Area Retina Associates - Walnut Creek | Walnut Creek | California | 94598 | — |
| Retina Group of New England, PC | Waterford | Connecticut | 06385 | — |
| Retina Group of Florida - Fort Myers Retina Center | Fort Myers | Florida | 33912 | — |
| East Florida Eye Institute | Stuart | Florida | 34994 | — |
| Florida Retina Institute Wildwood | Wildwood | Florida | 34785 | — |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | — |
| North Carolina Retina Associates | Wake Forest | North Carolina | 27587 | — |
| Red River Research Partners, LLC | Fargo | North Dakota | 58103 | — |
| Verum Research, LLC | Eugene | Oregon | 97401 | — |
| EyeHealth Northwest | Portland | Oregon | 97225 | — |
| Tennessee Retina | Nashville | Tennessee | 37203 | — |
| Austin Clinical Research, LLC | Austin | Texas | 78750 | — |
| Retina Consultants of Texas-Bellaire-67493 | Bellaire | Texas | 77401 | — |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Retina Consultants of Texas - San Antonio Medical Center | San Antonio | Texas | 78240 | — |
| Retina Consultants of Texas-The Woodlands-67575 | The Woodlands | Texas | 77384 | — |
| Strategic Clinical Research Group | Weatherford | Texas | 76087 | — |
| Emerson Clinical Research Institute | Falls Church | Virginia | 22042 | — |
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 Apr 27, 2026 · Synced Apr 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07553429 live on ClinicalTrials.gov.