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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
109
Oral dose of runcaciguat
Oral dose of matching placebo
Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye
DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
Time frame: At 48 weeks of treatment
Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye
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
Time frame: At 48 weeks
Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye
DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
Time frame: At 24 weeks of treatment
Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale
DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
Time frame: At 48 weeks of treatment
Number of Participants With Treatment Emergent Adverse Event (TEAE)
Time frame: From first dosing up to 28 days after last dose of study intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates - Central
Austin, Texas, United States
Retinal Consultants of Texas - Bellaire
Bellaire, Texas, United States
Gulf Coast Eye Institute / Valley Retina Institute
McAllen, Texas, United States
Retinal Consultants of Texas - San Antonio
San Antonio, Texas, United States
...and 45 more locations