Phase 2
N=109
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT04722991 ↗Enrolled (actual)
109
Serious AEs
11.0%
Results posted
Apr 2025
Primary outcome: Primary: Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye — 0.0; 1.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Runcaciguat (BAY1101042) (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye |
0.0; 1.9 | — |
| SECONDARY Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye |
17.6; 11.5 | — |
| SECONDARY Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale |
0.0; 1.9 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Event (TEAE) |
53; 44 | — |
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-field color fundus photography for central assessment of the diabetic retinopathy severity score, or DRSS. Two-step DRSS improvement at 24 weeks of treatment will be the primary efficacy endpoint. DRSS assessments are repeated after completion of 48 weeks of treatment. In addition, vision threatening complications will be recorded throughout the study and assessed as secondary efficacy endpoint.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04722991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.