Actively Recruiting
A First-in-human Study to Evaluate Safety and Tolerability of Multiple Intravitreal Doses of BI 3812465 in Adults With Center-involved Diabetic Macular Edema
Led by Boehringer Ingelheim · Updated on 2026-06-03
49
Participants Needed
30
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well different doses of a medicine called BI 3812465 are tolerated by adults with diabetic macular edema that affects the center of the eye. This is the first time BI 3812465 is given to humans. The study is designed in two parts: an initial phase with a small group receiving increasing doses and a second phase with a larger group randomized to low, medium, or high doses. Participants receive BI 3812465 as injections into the back of the eye, with a total of three eye injections administered. In Part 1, participants start with low doses and may move to higher doses if tolerated. In Part 2, participants are randomly assigned to one of three dose groups. The study follows participants for up to seven months, including the dosing and observation periods. During the study, participants visit the study site 19 times, with some visits possibly conducted at home when feasible. At these visits, doctors assess the severity of the eye condition and monitor any health problems that may be caused by the medicine. The main outcomes include monitoring for dose-limiting events and ocular adverse events over up to 169 days from the first drug administration.
CONDITIONS
Brief Title
A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of diabetes mellitus type 1 or type 2 under regular treatment with HbA1c less than 12%
- Center-involved diabetic macular edema confirmed by retinal imaging with central subfield thickness of 320 micrometers or more
- Clear enough ocular media and good pupil dilation for quality eye imaging
- Willingness and ability to understand study procedures and risks
- Signed informed consent prior to any study procedures
- Women of childbearing potential must use highly effective birth control
- Men must use contraception or abstain to prevent pregnancy of a partner
You will not qualify if you...
- Only one functional eye; the other eye must support daily functioning
- Active proliferative diabetic retinopathy
- Active retinal neovascularization requiring acute treatment
- Active neovascularization of the iris or anterior chamber angle (except small iris tufts)
- Additional eye diseases that may affect study participation such as uncontrolled glaucoma or high intraocular pressure over 24 mmHg despite treatment
- History of high myopia greater than 8 diopters in the study eye
- Eye abnormalities that prevent adequate detection of inflammation or other pathologies
- Previous ocular gene or cell therapy
- Use of corticosteroids locally or systemically within 1 month before screening
- Absence of the posterior capsule (aphakia) or recent YAG laser capsulotomy within 2 months
- Other conditions that might interfere with study outcomes as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 169 days
Participants receive multiple intravitreal doses of BI 3812465 at low, medium, or high doses to evaluate safety and tolerability.
Multiple visits for dosing and assessments during treatment period
Trial Site Locations
Total: 30 locations
1
Associated Retina Consultants, Ltd.
Phoenix, Arizona, United States, 85020
Not Yet Recruiting
2
Research Network Arizona
Scottsdale, Arizona, United States, 85255
Not Yet Recruiting
3
Win Retina
Arcadia, California, United States, 91006
Not Yet Recruiting
4
California Retina Consultants-Bakersfield-65523
Bakersfield, California, United States, 93309
Not Yet Recruiting
5
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Not Yet Recruiting
6
Global Research Management
Glendale, California, United States, 91204
Actively Recruiting
7
Retina Associates of Southern California
Huntington Beach, California, United States, 92647
Not Yet Recruiting
8
Retinal Consultants Medical Group
Sacramento, California, United States, 95825
Not Yet Recruiting
9
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States, 94598
Not Yet Recruiting
10
Retina Group of New England, PC
Waterford, Connecticut, United States, 06385
Not Yet Recruiting
11
Retina Group of Florida - Fort Myers Retina Center
Fort Myers, Florida, United States, 33912
Not Yet Recruiting
12
Florida Retina Consultants
Lakeland, Florida, United States, 33805
Not Yet Recruiting
13
East Florida Eye Institute
Stuart, Florida, United States, 34994
Not Yet Recruiting
14
Florida Retina Institute Wildwood
Wildwood, Florida, United States, 34785
Not Yet Recruiting
15
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
Not Yet Recruiting
16
Ophthalmic Consultants of Long Island
Oceanside, New York, United States, 11572
Not Yet Recruiting
17
North Carolina Retina Associates
Wake Forest, North Carolina, United States, 27587
Not Yet Recruiting
18
Red River Research Partners, LLC
Fargo, North Dakota, United States, 58103
Not Yet Recruiting
19
Verum Research, LLC
Eugene, Oregon, United States, 97401
Not Yet Recruiting
20
EyeHealth Northwest
Portland, Oregon, United States, 97225
Not Yet Recruiting
21
Tennessee Retina
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
22
Austin Clinical Research, LLC
Austin, Texas, United States, 78750
Not Yet Recruiting
23
Retina Consultants of Texas-Bellaire-67493
Bellaire, Texas, United States, 77401
Not Yet Recruiting
24
Valley Retina Institute, PA
McAllen, Texas, United States, 78503
Not Yet Recruiting
25
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Not Yet Recruiting
26
Retina Consultants of Texas - San Antonio Medical Center
San Antonio, Texas, United States, 78240
Not Yet Recruiting
27
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas, United States, 77384
Not Yet Recruiting
28
Strategic Clinical Research Group
Weatherford, Texas, United States, 76087
Not Yet Recruiting
29
Emerson Clinical Research Institute
Falls Church, Virginia, United States, 22042
Not Yet Recruiting
30
Emanuelli Research & Development Center
Arecibo, Puerto Rico, 00612
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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