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A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
NCT06321302 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG BI 764524
- DRUG Sham comparator to BI 764524
- DRUG Aflibercept (Eylea®) - US only
Study Locations (20)
California
- California Retina Consultants-Bakersfield-65523 — Bakersfield
- Retina-Vitreous Associates Medical Group — Beverly Hills
- Retinal Diagnostic Center — Campbell
- The Retina Partners — Encino
- Lugene Eye Institute — Glendale
- Retina Associates of Southern California — Huntington Beach
- Byers Eye Institute — Palo Alto
- California Eye Specialists Medical Group Inc — Pasadena
- Retinal Consultants Medical Group — Sacramento
- Retinal Consultants Medical Group — Sacramento
- California Retina Consultants-Santa Maria-65510 — Santa Maria
- Bay Area Retina Associates - Walnut Creek — Walnut Creek
Florida
- Florida Retina Institute — Jacksonville
- Florida Retina Consultants — Lakeland
- East Florida Eye Institute — Stuart
- Center for Retina and Macular Disease — Winter Haven
Arizona
- Associated Retina Consultants, Ltd. — Phoenix
Colorado
- Colorado Retina Associates — Lakewood
Connecticut
- Retina Group of New England, PC — Waterford
Hawaii
- Retina Consultants Of Hawaii — ‘Aiea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2027-09-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06321302
The ClinicalTrials.gov registry entry for NCT06321302 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 178 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Retinopathy appearing as the primary indexed condition, and to 3 interventions — of which BI 764524 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06321302 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06321302 about?
NCT06321302 is a clinical study titled "A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy". 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...
What is the current status of trial NCT06321302?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 178 participants. The study started on 2024-05-15. Estimated completion is 2027-09-17.
What conditions does trial NCT06321302 study?
This clinical trial studies the following conditions: Diabetic Retinopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06321302?
The interventions under investigation include: BI 764524 (DRUG), Sham comparator to BI 764524 (DRUG), Aflibercept (Eylea®) - US only (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06321302?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06321302 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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