A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated
Start Date
5/14/2026
Completion Date
7/6/2027
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 Criteria
Age Range: 18 years to No maximum
Interventions
Low dose BI 3812465
Medium dose BI 3812465
High dose BI 3812465
Conditions
Locations
Associated Retina Consultants, Ltd.
Phoenix, Arizona 85020
United States
Research Network Arizona
Scottsdale, Arizona 85255
United States
Win Retina
Arcadia, California 91006
United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United States
Global Research Management
Glendale, California 91204
United States
Retina Associates of Southern California
Huntington Beach, California 92647
United States
California Retina Consultants-Oxnard-70187
Oxnard, California 93036
United States
Retinal Consultants Medical Group
Sacramento, California 95825
United States
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California 94598
United States
Retina Group of New England, PC
Waterford, Connecticut 06385
United States
Retina Group of Florida - Fort Myers Retina Center
Fort Myers, Florida 33912
United States
Florida Retina Consultants
Lakeland, Florida 33805
United States
East Florida Eye Institute
Stuart, Florida 34994
United States
Florida Retina Institute Wildwood
Wildwood, Florida 34785
United States
Ophthalmic Consultants of Long Island
Oceanside, New York 11572
United States
North Carolina Retina Associates
Wake Forest, North Carolina 27587
United States
Red River Research Partners, LLC
Fargo, North Dakota 58103
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Verum Research, LLC
Eugene, Oregon 97401
United States
EyeHealth Northwest
Portland, Oregon 97225
United States
Tennessee Retina
Nashville, Tennessee 37203
United States
Austin Clinical Research, LLC
Austin, Texas 78750
United States
Retina Consultants of Texas-Bellaire-67493
Bellaire, Texas 77401
United States
Valley Retina Institute, PA
McAllen, Texas 78503
United States
Medical Center Ophthalmology Associates
San Antonio, Texas 78240
United States
Retina Consultants of Texas - San Antonio Medical Center
San Antonio, Texas 78240
United States
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas 77384
United States
Strategic Clinical Research Group
Willow Park, Texas 76087
United States
Emerson Clinical Research Institute
Falls Church, Virginia 22042
United States
Emanuelli Research & Development Center
Arecibo, 00612
Puerto Rico