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A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
Sponsor: Boehringer Ingelheim
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.
Official title: A Randomised, Double-masked, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral BI 1815368 in Participants With Centre-involved Diabetic Macular Edema for 48 Weeks of Treatment (THULITE)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-06-05
Completion Date
2027-09-29
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
BI 1815368
BI 1815368
Placebo
Placebo matching BI 1815368
Locations (80)
Win Retina
Arcadia, California, United States
Retina Associates of Southern California
Huntington Beach, California, United States
Retinal Consultants Medical Group, Inc
Modesto, California, United States
Doheny Eye Center UCLA Arcadia
Pasadena, California, United States
Retina Consultants of San Diego
Poway, California, United States
West Coast Retina Medical Group, Inc.
San Francisco, California, United States
Colorado Retina Associates
Lakewood, Colorado, United States
Advanced Research Institute
Pompano Beach, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Associated Vitreoretinal and Uveitis Consultants
Carmel, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Sierra Eye Associates
Reno, Nevada, United States
North Carolina Retina Associates
Wake Forest, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Verum Research, LLC
Eugene, Oregon, United States
Tennessee Retina
Nashville, Tennessee, United States
Austin Research Center for Retina, PLLC
Austin, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Center Of Texas
Southlake, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
West China Hospital, Sichuan University
Chengdu, China
Shanghai General Hospital
Shanghai, China
The Fourth People's Hospital of Shenyang
Shenyang, China
Shijiazhuang People's Hospital
Shijiazhuang, China
Shanxi Eye Hospital
Taiyuan, China
University Hospital Hradec Kralove (FNHK)
Hradec Králové, Czechia
University Hospital Ostrava
Ostrava-Poruba, Czechia
Oftex s.r.o.
Pardubice, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Fakultni Thomayerova nemocnice
Prague, Czechia
Axon Clinical s.r.o.
Prague, Czechia
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, Germany
Augenzentrum am St. Franziskus-Hospital Münster
Münster, Germany
Central Hospital of Northern Pest - Military Hospital
Budapest, Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, Hungary
Budapest Retina Associations Kft.
Budapest, Hungary
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
Nozologen Kft.
Pécs, Hungary
University of Pecs
Pécs, Hungary
University of Szeged
Szeged, Hungary
Asahikawa Medical University Hospital
Asahikawa-shi, Japan
Tokyo Medical University Hachioji Medical Center
Hachioji-shi, Japan
Kagawa University Hospital
Kita-gun, Japan
Kurume University Hospital
Kurume-shi, Japan
Shinshu University Hospital
Matsumoto-shi, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku, Japan
Nagoya City University Hospital
Nagayoga, Japan
Tokyo Women's Medical University Hospital
Tokyo, Japan
Juntendo University Urayasu Hospital
Urayasu-shi, Japan
Szpital Swietego Lukasza S. A.
Bielsko-Biala, Poland
Oculomedica Sp. z o.o.
Bydgoszcz, Poland
Clinical Medical Research Sp. z o.o.
Katowice, Poland
Szpital Sw. Rozy Sp. z o.o.
Krakow, Poland
Centrum Medyczne Dietla 19 Sp. z o.o.
Krakow, Poland
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
Olsztyn, Poland
Poznanskie Centrum Wzroku sp z o o
Poznan, Poland
Caminomed Sp. z o.o.
Tarnowskie Góry, Poland
Eb Group Sp. z o.o.
Warsaw, Poland
Warszawski Szpital Okulistyczny Sp. z o.o.
Warsaw, Poland
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, Slovakia
Nemocnica s poliklinikou Trebisov a.s.
Trebišov, Slovakia
Fakultna nemocnica Trencin
Trenčín, Slovakia
Fakultna nemocnica s poliklinikou Zilina
Žilina, Slovakia
Frimley Park Hospital
Camberley, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Moorfields Eye Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Sunderland Eye Infirmary
Sunderland, United Kingdom
Southend University Hospital
Westcliff-on-Sea, United Kingdom