Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

A regiszterben nem jelölt feltételek

• Main Inclusion Criteria:
• Moderately severe to severe NPDR in the study eye: Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53
• Diabetes type 1 or 2
• Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
  • Main Exclusion Criteria:
• 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
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 3 x Upper limit of normal (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 Nitric oxide (NO) donors (such as amyl nitrate) in any form including topical; Phosphodiesterase 5 (PDE5) inhibitors, nonspecific PDE inhibitors within 1 week or less than 5 half-lives (whichever is longer) before first study drug administration