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

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 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 ≥ 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.
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.
Number of Participants With Treatment Emergent Adverse Event (TEAE)	From first dosing up to 28 days after last dose of study intervention

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
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
Retinal Consultants of Texas - San Antonio
🇺🇸
San Antonio, Texas, United States
Retina Consultants of Texas - The Woodlands
🇺🇸
The Woodlands, Texas, United States
Eye center Sveti Luka
🇧🇬
Plovdiv, Bulgaria
UMHAT Sveti Georgi
🇧🇬
Plovdiv, Bulgaria
SEHAT Pentagram
🇧🇬
Sofia, Bulgaria
Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria
🇧🇬
Sofia, Bulgaria
Sveta Petka Eye Hospital
🇧🇬
Varna, Bulgaria
Ocni klinika Oftex
🇨🇿
Pardubice, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿
Praha 10, Czechia
Aalborg Universitetshospital - Øjenafdelingen
🇩🇰
Aalborg, Denmark
Aarhus Universitetshospital
🇩🇰
Aarhus N, Denmark
Rigshospitalet Glostrup - Øjensygdomme
🇩🇰
Glostrup, Denmark
Odense Universitetshospital, Dept of Ophtalmology
🇩🇰
Odense C, Denmark
Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme
🇩🇰
Roskilde, Denmark
NUVISAN GmbH Neu-Ulm
🇩🇪
Neu-Ulm, Bayern, Germany
Riga East University Hospital, Bikernieki, Ophthalmology Clinic
🇱🇻
Riga, Latvia
Academic Medical Center Dept Ophthalmology
🇳🇱
Amsterdam, Netherlands
Universitair Medisch Centrum St. Radboud
🇳🇱
Nijmegen, Netherlands
ETZ Elisabeth Ziekenhuis
🇳🇱
Tilburg, Netherlands
Biokinetica S.A
🇵🇱
Jozefow, Poland
Klinika Okulistyczna "Jasne Blonia" Sp. z o.o
🇵🇱
Lodz, Poland
Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.
🇵🇱
Rzeszow, Poland
Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski
🇵🇱
Tarnowskie Gory, Poland
NZOZ Centrum Badan Klinicznych
🇵🇱
Wroclaw, Poland
AIBILI
🇵🇹
Coimbra, Portugal
CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia
🇵🇹
Coimbra, Portugal
Centro Hospitalar Universitario do Porto
🇵🇹
Porto, Portugal
Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos
🇵🇹
Porto, Portugal
Clinical Emergency County Hospital
🇷🇴
Cluj-Napoca, Romania
Fakultna Nemocnica s poliklinikou F.D.Roosevelta
🇸🇰
Banska Bystrica, Slovakia
Nemocnica Poprad, a.s.
🇸🇰
Poprad, Slovakia
Hospital General de Catalunya
🇪🇸
Sant Cugat del Valles, Barcelona, Spain
Hospital Universitario del Henares
🇪🇸
Coslada, Madrid, Spain
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
🇪🇸
Barcelona, Spain
Hospital Universitario Virgen de la Macarena
🇪🇸
Sevilla, Spain
Universitätsspital Basel
🇨🇭
Basel, Basel-Stadt, Switzerland
Inselspital Universitätsspital Bern
🇨🇭
Bern, Switzerland
University Eye Hospital Jules Gonin
🇨🇭
Lausanne, Switzerland
Stadtspital Triemli
🇨🇭
Zürich, Switzerland
Sunderland Eye Infirmary
🇬🇧
Sunderland, Tyne And Wear, United Kingdom
Bristol Eye Hospital
🇬🇧
Bristol, United Kingdom
Moorfields Eye Hospital
🇬🇧
London, United Kingdom