Actively Recruiting
A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
Led by Boehringer Ingelheim · Updated on 2026-05-13
300
Participants Needed
80
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose. This study has 2 parts. In the first part, participants are put into 2 groups of equal size randomly, which means by chance. One group takes BI 1815368 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1815368 tablets but do not contain any medicine. In the second part, participants are put into 4 groups of equal size randomly. 3 groups take different daily doses of the study medicine, BI 1815368, while 1 group takes placebo. All participants take tablets twice a day for about 11 months. Participants are in the study for about 1 year. During this time, they visit the study site 16 times. At visits, doctors check the participant's vision and collect information on any health problems. They take detailed pictures of the eye. The changes over time are compared between the groups to see if the treatment works.
CONDITIONS
Official Title
A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with type 1 or type 2 diabetes mellitus with HbA1c less than 12%
- Stable diabetes medication for at least 30 days before Day 1 with no planned major changes
- Centre-involved diabetic macular edema (CI-DME) confirmed by spectral domain optical coherence tomography
- Central subfield foveal thickness of 320 micrometers or more in the study eye at screening
- Best corrected visual acuity (ETDRS letter score) between 24 and 78 in the study eye at screening
You will not qualify if you...
- Macular edema caused by conditions other than CI-DME in the study eye
- Proliferative diabetic retinopathy or iris neovascularization in the study eye
- Intravitreal anti-VEGF treatment in the study eye within 4 months before Day 1 (6 months for faricimab or aflibercept 8 mg)
- More than 4 prior intravitreal anti-VEGF injections in the study eye
- History of panretinal photocoagulation, macular laser photocoagulation, vitreoretinal surgery, or corticosteroid treatments within 12 months before Day 1
- Use of topical steroids or NSAIDs within 30 days before Day 1
- Active ocular inflammation or history of intraocular inflammation within 1 year
- Aphakia or total absence of posterior capsule in the study eye
- YAG laser capsulotomy in the study eye less than 2 months before Day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 80 locations
1
Win Retina
Arcadia, California, United States, 91006
Actively Recruiting
2
Retina Associates of Southern California
Huntington Beach, California, United States, 92647
Actively Recruiting
3
Retinal Consultants Medical Group, Inc
Modesto, California, United States, 95356
Actively Recruiting
4
Doheny Eye Center UCLA Arcadia
Pasadena, California, United States, 91103
Not Yet Recruiting
5
Retina Consultants of San Diego
Poway, California, United States, 92064
Not Yet Recruiting
6
West Coast Retina Medical Group, Inc.
San Francisco, California, United States, 94109
Actively Recruiting
7
Colorado Retina Associates
Lakewood, Colorado, United States, 80228
Actively Recruiting
8
Advanced Research Institute
Pompano Beach, Florida, United States, 33064
Actively Recruiting
9
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
Actively Recruiting
10
Associated Vitreoretinal and Uveitis Consultants
Carmel, Indiana, United States, 46032
Actively Recruiting
11
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
12
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
Actively Recruiting
13
Sierra Eye Associates
Reno, Nevada, United States, 89502
Actively Recruiting
14
North Carolina Retina Associates
Wake Forest, North Carolina, United States, 27587
Actively Recruiting
15
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
16
Verum Research, LLC
Eugene, Oregon, United States, 97401
Actively Recruiting
17
Tennessee Retina
Nashville, Tennessee, United States, 37203
Actively Recruiting
18
Austin Research Center for Retina, PLLC
Austin, Texas, United States, 78705
Actively Recruiting
19
Austin Retina Associates
Austin, Texas, United States, 78705
Actively Recruiting
20
Austin Clinical Research, LLC
Austin, Texas, United States, 78750
Actively Recruiting
21
Texas Retina Associates
Dallas, Texas, United States, 75231
Actively Recruiting
22
Retina Center Of Texas
Southlake, Texas, United States, 76092
Actively Recruiting
23
Retina Consultants of Texas
The Woodlands, Texas, United States, 77384
Actively Recruiting
24
West China Hospital, Sichuan University
Chengdu, China, 610041
Not Yet Recruiting
25
Shanghai General Hospital
Shanghai, China, 200080
Actively Recruiting
26
The Fourth People's Hospital of Shenyang
Shenyang, China, 110031
Not Yet Recruiting
27
Shijiazhuang People's Hospital
Shijiazhuang, China, 050011
Not Yet Recruiting
28
Shanxi Eye Hospital
Taiyuan, China, 030072
Actively Recruiting
29
University Hospital Hradec Kralove (FNHK)
Hradec Králové, Czechia, 500 03
Actively Recruiting
30
University Hospital Ostrava
Ostrava-Poruba, Czechia, 708 52
Actively Recruiting
31
Oftex s.r.o.
Pardubice, Czechia, 530 02
Actively Recruiting
32
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 100 00
Actively Recruiting
33
Vseobecna fakultni nemocnice v Praze
Prague, Czechia, 128 00
Not Yet Recruiting
34
Fakultni Thomayerova nemocnice
Prague, Czechia, 140 59
Not Yet Recruiting
35
Axon Clinical s.r.o.
Prague, Czechia, 150 00
Actively Recruiting
36
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany, 01307
Not Yet Recruiting
37
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Not Yet Recruiting
38
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Not Yet Recruiting
39
Universitätsklinikum Mannheim GmbH
Mannheim, Germany, 68167
Not Yet Recruiting
40
Augenzentrum am St. Franziskus-Hospital Münster
Münster, Germany, 48145
Not Yet Recruiting
41
Central Hospital of Northern Pest - Military Hospital
Budapest, Hungary, 1068
Not Yet Recruiting
42
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, Hungary, 1106
Not Yet Recruiting
43
Budapest Retina Associations Kft.
Budapest, Hungary, 1133
Not Yet Recruiting
44
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, Hungary, 1204
Not Yet Recruiting
45
University of Debrecen
Debrecen, Hungary, 4032
Not Yet Recruiting
46
Nozologen Kft.
Pécs, Hungary, 7621
Actively Recruiting
47
University of Pecs
Pécs, Hungary, 7623
Not Yet Recruiting
48
University of Szeged
Szeged, Hungary, 6720
Not Yet Recruiting
49
Asahikawa Medical University Hospital
Asahikawa-shi, Japan, 078-8510
Not Yet Recruiting
50
Tokyo Medical University Hachioji Medical Center
Hachioji-shi, Japan, 193-0998
Actively Recruiting
51
Kagawa University Hospital
Kita-gun, Japan, 761-0793
Actively Recruiting
52
Kurume University Hospital
Kurume-shi, Japan, 830-0011
Not Yet Recruiting
53
Shinshu University Hospital
Matsumoto-shi, Japan, 390-8621
Not Yet Recruiting
54
National Hospital Organization Tokyo Medical Center
Meguro-ku, Japan, 152-8902
Actively Recruiting
55
Nagoya City University Hospital
Nagayoga, Japan, 467-8602
Not Yet Recruiting
56
Tokyo Women's Medical University Hospital
Tokyo, Japan, 162-8666
Not Yet Recruiting
57
Juntendo University Urayasu Hospital
Urayasu-shi, Japan, 279-0021
Not Yet Recruiting
58
Szpital Swietego Lukasza S. A.
Bielsko-Biala, Poland, 43-309
Actively Recruiting
59
Oculomedica Sp. z o.o.
Bydgoszcz, Poland, 85-157
Actively Recruiting
60
Clinical Medical Research Sp. z o.o.
Katowice, Poland, 40-156
Actively Recruiting
61
Szpital Sw. Rozy Sp. z o.o.
Krakow, Poland, 30-394
Actively Recruiting
62
Centrum Medyczne Dietla 19 Sp. z o.o.
Krakow, Poland, 31-070
Actively Recruiting
63
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
Olsztyn, Poland, 10-424
Actively Recruiting
64
Poznanskie Centrum Wzroku sp z o o
Poznan, Poland, 60-538
Actively Recruiting
65
Caminomed Sp. z o.o.
Tarnowskie Góry, Poland, 42-600
Not Yet Recruiting
66
Eb Group Sp. z o.o.
Warsaw, Poland, 00-189
Not Yet Recruiting
67
Warszawski Szpital Okulistyczny Sp. z o.o.
Warsaw, Poland, 01-258
Actively Recruiting
68
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, Slovakia, 974 01
Actively Recruiting
69
Nemocnica s poliklinikou Trebisov a.s.
Trebišov, Slovakia, 075 01
Not Yet Recruiting
70
Fakultna nemocnica Trencin
Trenčín, Slovakia, 911 01
Not Yet Recruiting
71
Fakultna nemocnica s poliklinikou Zilina
Žilina, Slovakia, 101 01
Actively Recruiting
72
Frimley Park Hospital
Camberley, United Kingdom, GU16 7UJ
Actively Recruiting
73
Gloucestershire Royal Hospital
Gloucester, United Kingdom, GL1 3NN
Not Yet Recruiting
74
Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ
Actively Recruiting
75
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Actively Recruiting
76
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Actively Recruiting
77
King's College Hospital
London, United Kingdom, SE5 9RS
Not Yet Recruiting
78
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Actively Recruiting
79
Sunderland Eye Infirmary
Sunderland, United Kingdom, SR2 9HP
Not Yet Recruiting
80
Southend University Hospital
Westcliff-on-Sea, United Kingdom, SS0 0RY
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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