Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

Phase 2

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Runcaciguat (BAY1101042); Other: Placebo

• Registration Number: NCT04722991
• Lead Sponsor: Bayer

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-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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-22
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-25
• Study Start: 2021-03-17
• Primary Completion: 2024-03-18
• Study Completion: 2024-04-22
• Results First Submitted: 2025-03-17
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Results First Posted: 2025-04-08
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Runcaciguat (BAY1101042)	Runcaciguat (BAY1101042)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye	At 48 weeks of treatment	DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye	At 24 weeks of treatment	DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
Number of Participants With Treatment Emergent Adverse Event (TEAE)	From first dosing up to 28 days after last dose of study intervention
Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye	At 48 weeks	VTC are defined as occurrence of any of the following AEs: * Proliferative diabetic retinopathy (PDR) (DRSS ≥61); * Any ocular neo-vascularization (retinal or anterior-segment neovascularization); * Center-involved (central Early Treatment Diabetic Retinopathy Study \[ETDRS\] subfield) DME; * Drop of Best corrected visual acuity (BCVA) of 10 letters or more from baseline
Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale	At 48 weeks of treatment	DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.

Trial Locations

Locations (55)

Mid Atlantic Retina Specialists - Hagerstown; 🇺🇸 Hagerstown, Maryland, United States

Gulf Coast Eye Institute / Valley Retina Institute; 🇺🇸 McAllen, Texas, United States

Všeobecná fakultní nemocnice v Praze; 🇨🇿 Praha 2, Czechia

Axon Clinical, s.r.o.; 🇨🇿 Praha 5, Czechia

Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research Group; 🇬🇧 Gloucester, Gloucestershire, United Kingdom

King's College Hospital NHS Foundation Trust | King's College Hospital - Neurology Department; 🇬🇧 London, United Kingdom

Retinal Consultants Medical Group, Inc; 🇺🇸 Modesto, California, United States

Florida Retina Consultants; 🇺🇸 Lakeland, Florida, United States

Eye Associates of Pinellas; 🇺🇸 Pinellas Park, Florida, United States

Cumberland Valley Retina Consultants | Hagerstown, MD; 🇺🇸 Hagerstown, Maryland, United States

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