None listed
Conditions
Interventions
Product Name: BAY1101042 sodium modified-release coated 15mg GITS
Product Code: BAY1101042
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Runcaciguat
Current Sponsor code: BAY 11010
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Moderately severe to severe NPDR in the study eye: Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53 2. Diabetes type 1 or 2 3. Best corrected visual aquity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of =69 letters (approximate Snellen equivalent of 20/40 or better) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 157 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39
Exclusion criteria
Exclusion criteria: Uncontrolled diabetes mellitus as defined by HbA1c > 11.0% at screening Presence or history of macular edema involving the center of the macula Any kind of neovascular growth in the study eye, including anterior segment neovascularization Arterial hypotension with systolic blood pressure < 100 or diastolic blood pressure < 60mmHg ALT or AST above 3 x ULN or bilirubin = 1.5 ULN at screening, known ascites Estimated glomerular filtration rate (eGFR CKD-EPI) below 30 ml/min/1.73 m^2 at screening Any prior systemic anti-Vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye Any prior intraocular steroid injection in the study eye Any prior grid or focal laser photocoagulation within 500 microns of the foveal center or any prior Pan-retinal photocoagulation (PRP) in the study eye Use of nitrates or NO donors (such as amyl nitrate) in any form including topical; PDE5 inhibitors, non-specific PDE inhibitors within 1 week or less than 5 half-lives (whichever is longer) before first study drug administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the proof-of-concept for the efficacy of runcaciguat in the treatment of NPDR;Secondary Objective: To investigate the safety and tolerability of runcaciguat in patients with NPDR ;Primary end point(s): Diabetic Retinpathy Severity Scale (DRSS) improvment =2 steps at 24 Weeks of treatment in the study eye;Timepoint(s) of evaluation of this end point: 24 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Vision threatening complications at 48 weeks of treatment DRSS improvement =2 steps at 48 Weeks of treatment Frequency of treatment emergent adverse events;Timepoint(s) of evaluation of this end point: at 48 weeks of treatment at 48 weeks of treatment from first administration till 28 days after the last dose of the treatment | — |
Countries
Bulgaria, Czechia, Czech Republic, Denmark, Germany, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed