A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated
Condition(s) studied
Investigational drug(s) / intervention(s)
Low dose BI 3812465: BI 3812465
Medium dose BI 3812465: BI 3812465
High dose BI 3812465: BI 3812465
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.
Eligibility
Primary outcome measure(s)
- Part 1: Occurrence of dose limiting events (DLEs) from first investigational medicine product (IMP) administration until end of study (EOS) — Up to 169 days.
- Part 2: Occurrence of ocular adverse events (AEs) in the study eye from first IMP administration until EOS — Up to 169 days.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| Associated Retina Consultants, Ltd. | Phoenix | Arizona | Recruiting |
| Research Network Arizona | Scottsdale | Arizona | Recruiting |
| Win Retina | Arcadia | California | Recruiting |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | Recruiting |
| Global Research Management | Glendale | California | Recruiting |
| Retina Associates of Southern California | Huntington Beach | California | Not Yet Recruiting |
| California Retina Consultants-Oxnard-70187 | Oxnard | California | Recruiting |
| Retinal Consultants Medical Group | Sacramento | California | Recruiting |
| Bay Area Retina Associates - Walnut Creek | Walnut Creek | California | Recruiting |
| Retina Group of New England, PC | Waterford | Connecticut | Recruiting |
| Retina Group of Florida - Fort Myers Retina Center | Fort Myers | Florida | Recruiting |
| Florida Retina Consultants | Lakeland | Florida | Recruiting |
| East Florida Eye Institute | Stuart | Florida | Recruiting |
| Ophthalmic Consultants of Long Island | Oceanside | New York | Recruiting |
| North Carolina Retina Associates | Wake Forest | North Carolina | Recruiting |
| Red River Research Partners, LLC | Fargo | North Dakota | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Not Yet Recruiting |
| Verum Research, LLC | Eugene | Oregon | Recruiting |
| EyeHealth Northwest | Portland | Oregon | Recruiting |
| Tennessee Retina | Nashville | Tennessee | Recruiting |
| Austin Clinical Research, LLC | Austin | Texas | Recruiting |
| Retina Consultants of Texas-Bellaire-67493 | Bellaire | Texas | Recruiting |
| Valley Retina Institute, PA | McAllen | Texas | Recruiting |
| Medical Center Ophthalmology Associates | San Antonio | Texas | Recruiting |
| Retina Consultants of Texas | San Antonio | Texas | Recruiting |
| Retina Consultants of Texas-The Woodlands-67575 | The Woodlands | Texas | Not Yet Recruiting |
| Strategic Clinical Research Group | Willow Park | Texas | Recruiting |
| Emerson Clinical Research Institute | Falls Church | Virginia | Recruiting |
| Emanuelli Research & Development Center | Arecibo | Puerto Rico | Recruiting |
More Boehringer Ingelheim trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07553429 on ClinicalTrials.gov ↗ ← All trials in the USA