A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Public ClinicalTrials.gov record NCT06321302. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CRIMSON: A Multicentre, Randomised, Sham-controlled (and Active Controlled in the USA), Double-masked, 72-week Trial to Study the Safety, Tolerability, Pharmacokinetics, and Efficacy of 3 Dosing Regimens of Intravitreal BI 764524 in Patients With Moderate to Severe Non-proliferative Diabetic Retinopathy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06321302
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 190 participants
Conditions and interventions
Conditions
Interventions
- BI 764524 Drug
- Sham comparator to BI 764524 Drug
- Aflibercept (Eylea®) - US only Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 14, 2024
- Primary completion
- Mar 4, 2027
- Completion
- Aug 19, 2027
- Last update posted
- Sep 3, 2026
2024 – 2027
United States locations
- U.S. sites
- 40
- U.S. states
- 17
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Associated Retina Consultants, Ltd. | Phoenix | Arizona | 85020 | — |
| California Retina Consultants-Bakersfield-65523 | Bakersfield | California | 93309 | — |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | — |
| Retinal Diagnostic Center | Campbell | California | 95008 | — |
| The Retina Partners | Encino | California | 91436 | — |
| Lugene Eye Institute | Glendale | California | 91204 | — |
| Retina Associates of Southern California | Huntington Beach | California | 92647 | — |
| Byers Eye Institute | Palo Alto | California | 94303 | — |
| California Eye Specialists Medical Group Inc | Pasadena | California | 91107 | — |
| Retinal Consultants Medical Group | Sacramento | California | 95825 | — |
| Retinal Consultants Medical Group | Sacramento | California | 95841 | — |
| California Retina Consultants-Santa Maria-65510 | Santa Maria | California | 93454 | — |
| Bay Area Retina Associates - Walnut Creek | Walnut Creek | California | 94598 | — |
| Colorado Retina Associates | Lakewood | Colorado | 80228 | — |
| Retina Group of New England, PC | Waterford | Connecticut | 06385 | — |
| Florida Retina Institute | Jacksonville | Florida | 32216 | — |
| Florida Retina Consultants | Lakeland | Florida | 33805 | — |
| East Florida Eye Institute | Stuart | Florida | 34994 | — |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | — |
| Retina Consultants Of Hawaii | ‘Aiea | Hawaii | 96701 | — |
| Maine Eye Center | Portland | Maine | 04101 | — |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | — |
| Deep Blue Retina Clinical Research PLLC | Southaven | Mississippi | 38671 | — |
| NJRetina | Teaneck | New Jersey | 07666 | — |
| Long Island Vitreoretinal Consultants | Great Neck | New York | 11021 | — |
| Retina Vitreous Surgeons of Central NY, PC | Liverpool | New York | 13088 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| EyeHealth Northwest | Portland | Oregon | 97225 | — |
| Charleston Neuroscience Institute - Ladson | Ladson | South Carolina | 29456 | — |
| Tennessee Retina | Nashville | Tennessee | 37203 | — |
| Austin Retina Associates | Austin | Texas | 78705 | — |
| Retina Research Center, PLLC | Austin | Texas | 78705 | — |
| Austin Clinical Research, LLC | Austin | Texas | 78750 | — |
| Retina Consultants of Texas | Katy | Texas | 77494 | — |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | — |
| Austin Retina Associates | Round Rock | Texas | 78681 | — |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | — |
| Retina Consultants of Texas | San Antonio | Texas | 78240 | — |
| Retina Consultants of Texas - Schertz | Schertz | Texas | 78154 | — |
| Retina Associates of Utah | Salt Lake City | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 50 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06321302, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06321302 live on ClinicalTrials.gov.