A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Condition(s) studied
Investigational drug(s) / intervention(s)
BI 764524: BI 764524
Sham comparator to BI 764524: Sham comparator to BI 764524
Aflibercept (Eylea®) - US only: Aflibercept (Eylea®) - US only
Study summary
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.
Eligibility
Primary outcome measure(s)
- Occurrence of a ≥2-step improvement compared with baseline in Diabetic Retinopathy Severity Scale (DRSS) level in the study eye at Week 52 as assessed by Ultra-widefield colour fundus photography (UWF-CFP) images (within the 7-field grid) — At baseline and at Week 52
The DRSS is a scale which can take on the following discrete values: 10, 20, 35, 43, 47, 53, 61, 65, 71, 75, 81, 85. Here 10 means "No retinopathy" and 85 means "Advanced proliferative diabetic retinopathy, with posterior fundus obscured, or centre of macula detached". Thus, a higher score means symptoms get worse.
Trial sites (90)
| Facility | City | Region | Status |
|---|---|---|---|
| Associated Retina Consultants, Ltd. | Phoenix | Arizona | Active Not Recruiting |
| California Retina Consultants-Bakersfield-65523 | Bakersfield | California | Active Not Recruiting |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | Active Not Recruiting |
| Retinal Diagnostic Center | Campbell | California | Completed |
| The Retina Partners | Encino | California | Active Not Recruiting |
| Lugene Eye Institute | Glendale | California | Active Not Recruiting |
| Retina Associates of Southern California | Huntington Beach | California | Active Not Recruiting |
| Byers Eye Institute | Palo Alto | California | Completed |
| California Eye Specialists Medical Group Inc | Pasadena | California | Active Not Recruiting |
| Retinal Consultants Medical Group | Sacramento | California | Active Not Recruiting |
| Retinal Consultants Medical Group | Sacramento | California | Active Not Recruiting |
| California Retina Consultants-Santa Maria-65510 | Santa Maria | California | Active Not Recruiting |
| Bay Area Retina Associates - Walnut Creek | Walnut Creek | California | Active Not Recruiting |
| Colorado Retina Associates | Lakewood | Colorado | Active Not Recruiting |
| Retina Group of New England, PC | Waterford | Connecticut | Completed |
| Florida Retina Institute | Jacksonville | Florida | Recruiting |
| Florida Retina Consultants | Lakeland | Florida | Active Not Recruiting |
| East Florida Eye Institute | Stuart | Florida | Active Not Recruiting |
| Center for Retina and Macular Disease | Winter Haven | Florida | Active Not Recruiting |
| Retina Consultants Of Hawaii | ‘Aiea | Hawaii | Active Not Recruiting |
| Maine Eye Center | Portland | Maine | Active Not Recruiting |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | Active Not Recruiting |
| Deep Blue Retina Clinical Research PLLC | Southaven | Mississippi | Active Not Recruiting |
| NJRetina | Teaneck | New Jersey | Active Not Recruiting |
| Long Island Vitreoretinal Consultants | Great Neck | New York | Completed |
| Retina Vitreous Surgeons of Central NY, PC | Liverpool | New York | Active Not Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Active Not Recruiting |
| EyeHealth Northwest | Portland | Oregon | Completed |
| Charleston Neuroscience Institute - Ladson | Ladson | South Carolina | Completed |
| Tennessee Retina | Nashville | Tennessee | Active Not Recruiting |
| Austin Retina Associates | Austin | Texas | Active Not Recruiting |
| Retina Research Center, PLLC | Austin | Texas | Active Not Recruiting |
| Austin Clinical Research, LLC | Austin | Texas | Active Not Recruiting |
| Retina Consultants of Texas | Katy | Texas | Active Not Recruiting |
| Valley Retina Institute, PA | McAllen | Texas | Completed |
| Austin Retina Associates | Round Rock | Texas | Completed |
| Medical Center Ophthalmology Associates | San Antonio | Texas | Active Not Recruiting |
| Retina Consultants of Texas | San Antonio | Texas | Active Not Recruiting |
| Retina Consultants of Texas - Schertz | Schertz | Texas | Completed |
| Retina Associates of Utah | Salt Lake City | Utah | Recruiting |
+ 50 more sites — see the full list on the official registry below.
More Boehringer Ingelheim trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06321302 on ClinicalTrials.gov ↗ ← All trials in the USA