A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
Start Date
6/5/2025
Completion Date
9/29/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BI 1815368
Placebo
Conditions
Locations
Win Retina
Arcadia, California 91006
United States
Retina Associates of Southern California
Huntington Beach, California 92647
United States
Retinal Consultants Medical Group, Inc
Modesto, California 95356
United States
Doheny Eye Center UCLA Arcadia
Pasadena, California 91103
United States
Retina Consultants of San Diego
Poway, California 92064
United States
West Coast Retina Medical Group, Inc.
San Francisco, California 94109
United States
Colorado Retina Associates
Lakewood, Colorado 80228
United States
Advanced Research Institute
Pompano Beach, Florida 33064
United States
Center for Retina and Macular Disease
Winter Haven, Florida 33880
United States
Associated Vitreoretinal and Uveitis Consultants
Carmel, Indiana 46032
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
United States
Sierra Eye Associates
Reno, Nevada 89502
United States
North Carolina Retina Associates
Wake Forest, North Carolina 27587
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Verum Research, LLC
Eugene, Oregon 97401
United States
Tennessee Retina
Nashville, Tennessee 37203
United States
Austin Research Center for Retina, PLLC
Austin, Texas 78705
United States
Austin Retina Associates
Austin, Texas 78705
United States
Austin Clinical Research, LLC
Austin, Texas 78750
United States
Texas Retina Associates
Dallas, Texas 75231
United States
Retina Center Of Texas
Southlake, Texas 76092
United States
Retina Consultants of Texas
The Woodlands, Texas 77384
United States
West China Hospital, Sichuan University
Chengdu, 610041
China
Shanghai General Hospital
Shanghai, 200080
China
The Fourth People's Hospital of Shenyang
Shenyang, 110031
China
Shijiazhuang People's Hospital
Shijiazhuang, 050011
China
Shanxi Eye Hospital
Taiyuan, 030072
China
University Hospital Hradec Kralove (FNHK)
Hradec Králové, 500 03
Czechia
University Hospital Ostrava
Ostrava-Poruba, 708 52
Czechia
Oftex s.r.o.
Pardubice, 530 02
Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 00
Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 00
Czechia
Fakultni Thomayerova nemocnice
Prague, 140 59
Czechia
Axon Clinical s.r.o.
Prague, 150 00
Czechia
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307
Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Germany
Universitätsklinikum Leipzig
Leipzig, 04103
Germany
Universitätsklinikum Mannheim GmbH
Mannheim, 68167
Germany
Augenzentrum am St. Franziskus-Hospital Münster
Münster, 48145
Germany
Central Hospital of Northern Pest - Military Hospital
Budapest, 1068
Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106
Hungary
Budapest Retina Associations Kft.
Budapest, 1133
Hungary
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204
Hungary
University of Debrecen
Debrecen, 4032
Hungary
Nozologen Kft.
Pécs, 7621
Hungary
University of Pecs
Pécs, 7623
Hungary
University of Szeged
Szeged, 6720
Hungary
Asahikawa Medical University Hospital
Asahikawa-shi, 078-8510
Japan
Tokyo Medical University Hachioji Medical Center
Hachioji-shi, 193-0998
Japan
Kagawa University Hospital
Kita-gun, 761-0793
Japan
Kurume University Hospital
Kurume-shi, 830-0011
Japan
Shinshu University Hospital
Matsumoto-shi, 390-8621
Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, 152-8902
Japan
Nagoya City University Hospital
Nagayoga, 467-8602
Japan
Tokyo Women's Medical University Hospital
Tokyo, 162-8666
Japan
Juntendo University Urayasu Hospital
Urayasu-shi, 279-0021
Japan
Szpital Swietego Lukasza S. A.
Bielsko-Biala, 43-309
Poland
Oculomedica Sp. z o.o.
Bydgoszcz, 85-157
Poland
Clinical Medical Research Sp. z o.o.
Katowice, 40-156
Poland
Szpital Sw. Rozy Sp. z o.o.
Krakow, 30-394
Poland
Centrum Medyczne Dietla 19 Sp. z o.o.
Krakow, 31-070
Poland
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
Olsztyn, 10-424
Poland
Poznanskie Centrum Wzroku sp z o o
Poznan, 60-538
Poland
Caminomed Sp. z o.o.
Tarnowskie Góry, 42-600
Poland
Eb Group Sp. z o.o.
Warsaw, 00-189
Poland
Warszawski Szpital Okulistyczny Sp. z o.o.
Warsaw, 01-258
Poland
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, 974 01
Slovakia
Nemocnica s poliklinikou Trebisov a.s.
Trebišov, 075 01
Slovakia
Fakultna nemocnica Trencin
Trenčín, 911 01
Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, 101 01
Slovakia
Frimley Park Hospital
Camberley, GU16 7UJ
United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
United Kingdom
Northwick Park Hospital
Harrow, HA1 3UJ
United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP
United Kingdom
Moorfields Eye Hospital
London, EC1V 2PD
United Kingdom
King's College Hospital
London, SE5 9RS
United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP
United Kingdom
Southend University Hospital
Westcliff-on-Sea, SS0 0RY
United Kingdom