A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
- Registration Number
- NCT06962839
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: Treatment arm BI 1815368 - Cohort 1: Placebo arm Placebo - Cohort 2: Placebo arm Placebo - Cohort 2: Treatment arm, low dose BI 1815368 - Cohort 2: Treatment arm, medium dose BI 1815368 - Cohort 2: Treatment arm, high dose BI 1815368 -
- Primary Outcome Measures
Name Time Method 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 at baseline, 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.
- Secondary Outcome Measures
Name Time Method Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48 at baseline, 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.
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 at baseline, at week 48 Occurrence (yes/no) of drug-related adverse events (AEs) over the treatment period through end of study (EoS) up to 52 weeks
Trial Locations
- Locations (9)
Retinal Consultants Medical Group, Inc
🇺🇸Modesto, California, United States
Retina Consultants of San Diego
🇺🇸Poway, California, United States
Advanced Research Institute
🇺🇸Pompano Beach, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, 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
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Retina Center Of Texas
🇺🇸Southlake, Texas, United States