NCT04722991

Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

A Phase 2 Randomized, Placebo-controlled, Double-masked Proof-of-concept Study to Investigate the Efficacy and Safety of Runcaciguat (BAY 1101042) in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Runcaciguat (BAY1101042)	Oral dose of runcaciguat
OTHER	Placebo	Oral dose of matching placebo

Timeline

• Start date: 2021-03-17
• Primary completion: 2024-03-18
• Completion: 2024-04-22
• First posted: 2021-01-25
• Last updated: 2025-04-08
• Results posted: 2025-04-08

Locations

55 sites across 14 countries: United States, Bulgaria, Czechia, Denmark, Germany, Latvia, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study