A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy

ClinicalTrials.gov ID: NCT06321302

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.

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ClinicalTrials.gov public records Last synced Oct 21, 2026, 10:33 AM EDT

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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: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Boehringer Ingelheim; Industry
Enrollment: 175 participants

Conditions and interventions

Conditions

Diabetic Retinopathy

Interventions

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 15, 2024 (Actual)
Primary completion: Mar 5, 2027 (Estimated)
Completion: Aug 20, 2027 (Estimated)
Last update posted: Oct 15, 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	Active, not recruiting
California Retina Consultants-Bakersfield-65523	Bakersfield	California	93309	Active, not recruiting
Retina-Vitreous Associates Medical Group	Beverly Hills	California	90211	Active, not recruiting
Retinal Diagnostic Center	Campbell	California	95008	Completed
The Retina Partners	Encino	California	91436	Active, not recruiting
Lugene Eye Institute	Glendale	California	91204	Active, not recruiting
Retina Associates of Southern California	Huntington Beach	California	92647	Active, not recruiting
Byers Eye Institute	Palo Alto	California	94303	Completed
California Eye Specialists Medical Group Inc	Pasadena	California	91107	Active, not recruiting
Retinal Consultants Medical Group	Sacramento	California	95825	Active, not recruiting
Retinal Consultants Medical Group	Sacramento	California	95841	Active, not recruiting
California Retina Consultants-Santa Maria-65510	Santa Maria	California	93454	Active, not recruiting
Bay Area Retina Associates - Walnut Creek	Walnut Creek	California	94598	Active, not recruiting
Colorado Retina Associates	Lakewood	Colorado	80228	Active, not recruiting
Retina Group of New England, PC	Waterford	Connecticut	06385	Completed
Florida Retina Institute	Jacksonville	Florida	32216	Active, not recruiting
Florida Retina Consultants	Lakeland	Florida	33805	Active, not recruiting
East Florida Eye Institute	Stuart	Florida	34994	Active, not recruiting
Center for Retina and Macular Disease	Winter Haven	Florida	33880	Active, not recruiting
Retina Consultants Of Hawaii	‘Aiea	Hawaii	96701	Active, not recruiting
Maine Eye Center	Portland	Maine	04101	Active, not recruiting
Cumberland Valley Retina Consultants	Hagerstown	Maryland	21740	Active, not recruiting
Deep Blue Retina Clinical Research PLLC	Southaven	Mississippi	38671	Active, not recruiting
NJRetina	Teaneck	New Jersey	07666	Active, not recruiting
Long Island Vitreoretinal Consultants	Great Neck	New York	11021	Completed
Retina Vitreous Surgeons of Central NY, PC	Liverpool	New York	13088	Active, not recruiting
University Hospitals Cleveland Medical Center	Cleveland	Ohio	44106	Active, not recruiting
EyeHealth Northwest	Portland	Oregon	97225	Completed
Charleston Neuroscience Institute - Ladson	Ladson	South Carolina	29456	Active, not recruiting
Tennessee Retina	Nashville	Tennessee	37203	Active, not recruiting
Austin Retina Associates	Austin	Texas	78705	Active, not recruiting
Retina Research Center, PLLC	Austin	Texas	78705	Active, not recruiting
Austin Clinical Research, LLC	Austin	Texas	78750	Active, not recruiting
Retina Consultants of Texas	Katy	Texas	77494	Active, not recruiting
Valley Retina Institute, PA	McAllen	Texas	78503	Completed
Austin Retina Associates	Round Rock	Texas	78681	Completed
Medical Center Ophthalmology Associates	San Antonio	Texas	78240	Active, not recruiting
Retina Consultants of Texas	San Antonio	Texas	78240	Active, not recruiting
Retina Consultants of Texas - Schertz	Schertz	Texas	78154	Completed
Retina Associates of Utah	Salt Lake City	Utah	84107	Recruiting

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 Oct 15, 2026 · Synced Oct 21, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT06321302 live on ClinicalTrials.gov.

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