18 and older, any sex, with Macular Edema. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12Primary· Baseline and Week 12
The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean.
Group
Value
95% CI
Placebo Matching to BI 1026706
-6.19
± 11.61
BI 1026706
10.26
± 11.64
Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)Secondary· From first drug administration until 4 days after last drug administration, up to 89 days.
Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs) comparing the BI 1026706 treatment group with the placebo group is presented.
Total with SAEs
Group
Value
95% CI
Placebo Matching to BI 1026706
2
BI 1026706
7
Investigator defined drug-related AE
Group
Value
95% CI
Placebo Matching to BI 1026706
7
BI 1026706
7
AESIs
Group
Value
95% CI
Placebo Matching to BI 1026706
0
BI 1026706
1
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration until 4 days after last drug administration, up to 89 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT02652416 — Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers
· Phase 1
· completed
NCT02657408 — Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Vers
· Phase 1
· completed
NCT02642614 — Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD
· Phase 1
· completed
NCT02513446 — Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1026706 in Healthy Male Sub
· Phase 1
· completed
NCT02126826 — Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Fema
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 20 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02732951.