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

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Enrollment reopened
    • Enrollment target: 190 to 175
    • Site details revised at 90 of 90 sites
  2. Re-verified, no change to tracked fields
  3. Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 3 of 9 entries
    • Site details revised at 4 of 90 sites
  4. Re-verified, no change to tracked fieldsv45
  5. Trial sites expanded: 84 → 90 locationsv44
  6. Re-verified, no change to tracked fieldsv43
  7. Trial sites reduced: 89 → 84 locationsv42
  8. 2 versions Re-verified since Jun 11, 2026, no change to tracked fieldsv40-v41
  9. Enrollment target: 188 to 190v39
  10. Enrollment target: 187 to 188
    • Eligibility criteria revised
    v38
  11. Primary completion moved earlier from Apr 30, 2027 to Mar 5, 2027
    • Study completion date: Sep 17, 2027 to Aug 20, 2027
    • Eligibility criteria revised
    v37
  12. Primary endpoint(s) modifiedv36 Show 5 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: estimated 178 to confirmed 187
    • Eligibility criteria expanded, about 70 words
    • Secondary endpoints revised (9)
    • Study sites revised (89)
  13. Site details revised at 2 of 89 sitesv35
  14. Site details revised at 3 of 89 sitesv34
  15. Site details revised at 4 of 89 sitesv33
  16. Study sites: 88 to 89v32
  17. Primary completion date: Jul 1, 2026 to Apr 30, 2027
    • Study sites: 89 to 88
    v31
  18. Study completion date: Nov 11, 2026 to Sep 17, 2027
    • Eligibility criteria expanded, about 107 words
    • Secondary endpoints revised (9)
    • Study sites revised (89)
    v30
  19. Site details revised at 3 of 89 sitesv29
  20. Site details revised at 1 of 89 sitesv28
  21. Study sites: 87 to 89v27
  22. Site details revised at 1 of 87 sitesv26
  23. Study sites: 84 to 87v25
  24. Study sites: 83 to 84v24
  25. Study sites: 82 to 83v23
  26. Study sites: 79 to 82v22
  27. Study sites revised (79)v21
  28. Site details revised at 5 of 79 sitesv20
  29. Study sites: 46 to 79v19
  30. Study sites: 31 to 46v18
  31. Study sites: 29 to 31v17
  32. Study sites: 25 to 29v16
  33. Study sites: 23 to 25v15
  34. Study sites: 22 to 23v14
  35. Study sites: 14 to 22v13
  36. Study sites: 32 to 14
    • Start date: May 7, 2024 to May 15, 2024
    v12
  37. Study sites: 26 to 32v11
  38. Study sites: 24 to 26v10
  39. Study sites: 18 to 24v9
  40. Study sites: 11 to 18v8
  41. Study sites: 10 to 11v7
  42. Study sites: 8 to 10v6
  43. Study sites: 3 to 8v5
  44. Study sites: 1 to 3v4
  45. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Enrollment target: 175 to 178
    • Study sites: 0 to 1
    • Start date changed from estimate of May 8, 2024 to May 7, 2024
    • Eligibility criteria expanded, about 2 words
  46. Secondary endpoints revised (9)v2
  47. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Boehringer Ingelheim
223 trials monitored
See 11 trials at risk
Diabetes
5,101 trials monitored
See 233 trials at risk
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.
Trial Details
NCT Number NCT06321302
Lead Sponsor Boehringer Ingelheim
Conditions
(from sponsor)		 Diabetic Retinopathy
Related terms Diabetic Retinopathy
Enrollment 175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov