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NCT06321302 · ClinicalTrials.gov registry record · Phase 2
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
A Phase 2 study of Diabetic Retinopathy, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 178
- Enrollment target
- 20
- Study locations
NCT06321302: Recruiting Phase 2 study of Diabetic Retinopathy, sponsored by Boehringer Ingelheim.
NCT06321302 is a Phase 2 study of Diabetic Retinopathy that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 178 participants, below the 1,673-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06321302, a Phase 2 study of Diabetic Retinopathy, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 178 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
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 |
What NCT06321302 shows while recruiting
NCT06321302 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 1,673-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (89% lower).
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.
NCT06321302 names 20 study sites across 6 states, led by California, Florida, Arizona.
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.
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).
Who is sponsoring clinical trial NCT06321302?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06321302's enrollment target sits among peer trials
178 29th of 57 higher than 29 of 57 other Diabetic Retinopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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