Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06962839 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema

StatusRecruiting
PhasePhase 2
Started2025-06-05
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
minor
Study Status, Contacts/Locations v30
Trial sites expanded: 90 → 97 locations
2026-08-20
minor
Study Status, Contacts/Locations v29
Study sites89→90
2026-08-05
minor
Study Status, Contacts/Locations v28
Trial sites expanded: 80 → 89 locations
2026-07-08
minor
Study Status, Contacts/Locations v27
Study sitesdetails revised at 1 of 80 sites
2026-06-23
minor
Study Status, Contacts/Locations v26
Study sitesdetails revised at 2 of 80 sites
Show 25 earlier versions
2026-06-09
minor
Study Status, Contacts/Locations v25
Study sitesdetails revised at 9 of 80 sites
2026-05-31
minor
Study Status, Contacts/Locations v24
Study sitesdetails revised at 9 of 80 sites
2026-05-12
minor
Study Status, Contacts/Locations v23
Study sitesdetails revised at 3 of 80 sites
2026-04-28
minor
Study Status, Contacts/Locations v22
Study sitesdetails revised at 10 of 80 sites
2026-04-14
minor
Study Status, Contacts/Locations v21
Study sitesdetails revised at 9 of 80 sites
2026-04-01
minor
Study Status, Contacts/Locations v20
Study sites80 entries, revised
Frimley Park Hospital NHS Foundation Trust
2026-03-17
minor
Study Status, Eligibility, Contacts/Locations v19
Eligibility criteria-9 characters
[...] D-OCT) with central subfield foveal thickness (CST) ≥320 µm for male and ≥305 µm for female participants in the study eye at screening Best corrected visual acuity ( [...] r (VEGF) treatment within 4 months before Day 1 (other than Vabysmo®faricimab or Eylea®aflibercept HD8mg), and within 6 months before Day 1 for Vabysmo®faricimab or Eylea®aflibercept HD8 mg, and/or more than 4 prior IVT injections with anti-VEGF tre [...] in the study eye Any history of panretinal photocoagulation treatment, macular laser photocoagulation, vitreoretinal surgery, IVT [...] eroid treatment (within 12 months before Day 1), history [...]
Study sitesdetails revised at 8 of 80 sites
2026-03-04
minor
Study Status, Contacts/Locations v18
Study sitesdetails revised at 3 of 80 sites
2026-02-17
minor
Study Status, Contacts/Locations, IPDSharing, References v17
Study sitesdetails revised at 3 of 80 sites
2026-02-04
minor
Study Status, Contacts/Locations v16
Study sites80 entries, revised
West China Hospital of, Sichuan University
2026-01-20
minor
Study Status, Contacts/Locations v15
Study sitesdetails revised at 4 of 80 sites
2026-01-08
minor
Study Status, Contacts/Locations v14
Study sitesdetails revised at 5 of 80 sites
2025-12-19
minor
Study Status, Contacts/Locations v13
Study sites79→80
2025-12-11
minor
Study Status, Contacts/Locations v12
Study sites79 entries, revised
Cumberland Valley Retina Consultants, PC.
2025-11-11
minor
Study Status, Contacts/Locations v11
Study sites76→79
2025-10-29
minor
Study Status, Contacts/Locations v10
Study sites76 entries, revised
Retina Consultants Ofof Texas
2025-10-15
minor
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 76 sites
2025-09-16
minor
Study Status, Contacts/Locations v8
Study sites69→76
2025-09-02
minor
Study Status, Contacts/Locations v7
Study sites19→69
2025-08-22
minor
Study Status, Contacts/Locations v6
Study sites17→19
2025-08-05
minor
Study Status, Contacts/Locations v5
Study sites14→17
2025-07-25
minor
Study Status, Contacts/Locations v4
Study sites13→14
2025-07-07
minor
Study Status, Contacts/Locations v3
Study sites10→13
2025-06-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05-30→confirmed 2025-06-05
Study sites9→10
2025-05-26
minor
Study Status, Contacts/Locations v1
Study sites0→9
2025-04-30
minor
Original filing
This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose. This study has 2 parts. In the first part, participants are put into 2 groups of equal size randomly, which means by chance. One group takes BI 1815368 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1815368 tablets but do not contain any medicine. In the second part, participants are put into 4 groups of equal size randomly. 3 groups take different daily doses of the study medicine, BI 1815368, while 1 group takes placebo. All participants take tablets twice a day for about 11 months. Participants are in the study for about 1 year. During this time, they visit the study site 16 times. At visits, doctors check the participant's vision and collect information on any health problems. They take detailed pictures of the eye. The changes over time are compared between the groups to see if the treatment works.
Trial Details
NCT Number NCT06962839
Lead Sponsor Boehringer Ingelheim
Conditions Macular Edema
Enrollment 300 participants
Start Date 2025-06-05
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-09-29 (estimated)
Updated on ClinicalTrials.gov 2026-10-01