A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Diabetic Retinopathy
In brief
This study is open to adults with diabetic retinopathy. People who have non-proliferative diabetic retinopathy of moderate or high severity can join the study. The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy. The study also aims to find a suitable treatment plan for BI 764524. Participants are put into 5 groups by chance. Participants in groups 1, 2, and 3 get BI 764524. Over 1 year, they get a different number of injections of the same dose of BI 764524 injected into 1 eye. During some visits, participants may get a sham control, which is done like an eye injection but without a needle, so that participants will not know how many injections of BI 764524 they received. Participants in group 4 only get a sham control. Participants in group 5 (only in the USA) get aflibercept or sham injections during some visits. Aflibercept is a medicine already used to treat diabetic retinopathy. Participants are in the study for one and a half years. During this time, they visit the study site at least 16 times. During this time, doctors regularly do eye exams and visual tests to assess the severity of participants' eye condition. After 1 year of treatment, researchers look at the number of participants with eye improvements. To do so, they compare eye damage and certain severe eye problems between the groups of participants. The doctors also regularly check participants' health and take note of any unwanted effects.
Key facts
- Study ID
- NCT06321302
- Run by
- Boehringer Ingelheim
- People needed
- 190
- Starts
- 2024-05-15
- Expected to finish
- 2027-08-20
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- California Retina Consultants-Bakersfield-65523 — Bakersfield, California, United States
- Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
- Retinal Diagnostic Center — Campbell, California, United States
- The Retina Partners — Encino, California, United States
- Lugene Eye Institute — Glendale, California, United States
- Retina Associates of Southern California — Huntington Beach, California, United States
- Byers Eye Institute — Palo Alto, California, United States
- California Eye Specialists Medical Group Inc — Pasadena, California, United States
- Retinal Consultants Medical Group — Sacramento, California, United States
- Retinal Consultants Medical Group — Sacramento, California, United States
- California Retina Consultants-Santa Maria-65510 — Santa Maria, California, United States
- Bay Area Retina Associates - Walnut Creek — Walnut Creek, California, United States
- Colorado Retina Associates — Lakewood, Colorado, United States
- Retina Group of New England, PC — Waterford, Connecticut, United States
- Florida Retina Institute — Jacksonville, Florida, United States
- Florida Retina Consultants — Lakeland, Florida, United States
- East Florida Eye Institute — Stuart, Florida, United States
- Center for Retina and Macular Disease — Winter Haven, Florida, United States
- Retina Consultants Of Hawaii — ‘Aiea, Hawaii, United States
- Maine Eye Center — Portland, Maine, United States
- Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
- Deep Blue Retina Clinical Research PLLC — Southaven, Mississippi, United States
- NJRetina — Teaneck, New Jersey, United States
- Long Island Vitreoretinal Consultants — Great Neck, New York, United States
- Associated Retina Consultants, Ltd. — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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