Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
Status:
Recruiting
Trial end date:
2026-01-27
Target enrollment:
Participant gender:
Summary
This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the
treatment of diabetic retinopathy. The study consists of two parts, Part A and Part B. Part A
is designed to assess the safety and efficacy of runcaciguat in NPDR patients. Part B is
designed to investigate the dose-response of runcaciguat in the treatment of diabetic
retinopathy and to determine the dose with the best benefit/risk ratio. 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, 72, and 96 weeks of treatment. In addition, vision threatening
complications will be recorded throughout the study and assessed as secondary efficacy
endpoint.