Condition: Macular Edema · Sponsor: Boehringer Ingelheim
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.
This description comes directly from the study's public registry record.
Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com
Always discuss trial participation with your own doctor first.
| Win Retina | Arcadia, California, United States | Recruiting |
| Retina Associates of Southern California | Huntington Beach, California, United States | Recruiting |
| Retinal Consultants Medical Group, Inc | Modesto, California, United States | Recruiting |
| Doheny Eye Center UCLA Arcadia | Pasadena, California, United States | Not Yet Recruiting |
| Retina Consultants of San Diego | Poway, California, United States | Not Yet Recruiting |
| West Coast Retina Medical Group, Inc. | San Francisco, California, United States | Recruiting |
| Colorado Retina Associates | Lakewood, Colorado, United States | Recruiting |
| Advanced Research Institute | Pompano Beach, Florida, United States | Recruiting |
| Center for Retina and Macular Disease | Winter Haven, Florida, United States | Recruiting |
| Associated Vitreoretinal and Uveitis Consultants | Carmel, Indiana, United States | Recruiting |
| University of Kansas Medical Center | Kansas City, Kansas, United States | Not Yet Recruiting |
| Cumberland Valley Retina Consultants | Hagerstown, Maryland, United States | Recruiting |
+ 68 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06962839