A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy (NCT06321302)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Associated Retina Consultants, Ltd. — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (90 Sites)
Showing the first 25 of 90 sites.
- Associated Retina Consultants, Ltd. — Phoenix, Arizona
- California Retina Consultants-Bakersfield-65523 — Bakersfield, California
- Retina-Vitreous Associates Medical Group — Beverly Hills, California
- Retinal Diagnostic Center — Campbell, California
- The Retina Partners — Encino, California
- Lugene Eye Institute — Glendale, California
- Retina Associates of Southern California — Huntington Beach, California
- Byers Eye Institute — Palo Alto, California
- California Eye Specialists Medical Group Inc — Pasadena, California
- Retinal Consultants Medical Group — Sacramento, California
- Retinal Consultants Medical Group — Sacramento, California
- California Retina Consultants-Santa Maria-65510 — Santa Maria, California
- Bay Area Retina Associates - Walnut Creek — Walnut Creek, California
- Colorado Retina Associates — Lakewood, Colorado
- Retina Group of New England, PC — Waterford, Connecticut
- Florida Retina Institute — Jacksonville, Florida
- Florida Retina Consultants — Lakeland, Florida
- East Florida Eye Institute — Stuart, Florida
- Center for Retina and Macular Disease — Winter Haven, Florida
- Retina Consultants Of Hawaii — ‘Aiea, Hawaii
- Maine Eye Center — Portland, Maine
- Cumberland Valley Retina Consultants — Hagerstown, Maryland
- Deep Blue Retina Clinical Research PLLC — Southaven, Mississippi
- NJRetina — Teaneck, New Jersey
- Long Island Vitreoretinal Consultants — Great Neck, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Retinopathy
- Vascular Reparative Mechanism in Diabetes — Birmingham, Alabama
- OCT Biomarkers for Diabetic Retinopathy — Portland, Oregon
- WF and PR OCTA in Diabetic Retinopathy — Portland, Oregon
- Camera Qualification Study — Norco, California
- Implementation of Teleophthalmology in Urban Health Systems Study — Madison, Wisconsin
Explore by condition: All Diabetic Retinopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.