Status:
COMPLETED
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
Lead Sponsor:
Bayer
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-fie...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2024
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04722991
Start Date
March 17 2021
End Date
April 22 2024
Last Update
April 8 2025
Active Locations (55)
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1
Retinal Consultants Medical Group, Inc
Modesto, California, United States, 95256
2
Florida Retina Consultants
Lakeland, Florida, United States, 33805
3
Eye Associates of Pinellas
Pinellas Park, Florida, United States, 33782
4
Cumberland Valley Retina Consultants | Hagerstown, MD
Hagerstown, Maryland, United States, 21740