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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
BI 1815368
Placebo matching BI 1815368
Arizona Retina & Vitreous Research, Central Phoenix
Phoenix, Arizona, United States
NOT_YET_RECRUITINGWin Retina
Arcadia, California, United States
RECRUITINGRetina Associates of Southern California
Huntington Beach, California, United States
RECRUITINGRetinal Consultants Medical Group, Inc
Modesto, California, United States
Occurrence (yes/no) of a gain of ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with baseline in the study eye at Week 48
With ETDRS letters, the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters is measured.
Time frame: at baseline, at week 48
Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48
With ETDRS letters, the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters is measured.
Time frame: at baseline, at week 48
Occurrence (yes/no) of drug-related adverse events (AEs) over the treatment period through end of study (EoS)
Time frame: up to 52 weeks
Absolute change from baseline of central subfield foveal thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) in the study eye at Week 48
Time frame: at baseline, at week 48
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Eye Research Foundation
Newport Beach, California, United States
NOT_YET_RECRUITINGDoheny Eye Center UCLA Arcadia
Pasadena, California, United States
RECRUITINGRetina Consultants of San Diego
Poway, California, United States
RECRUITINGWest Coast Retina Medical Group, Inc.
San Francisco, California, United States
RECRUITINGColorado Retina Associates
Lakewood, Colorado, United States
RECRUITINGConnecticut Eye Consultants, PC
Danbury, Connecticut, United States
NOT_YET_RECRUITING...and 86 more locations