Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
NCT ID: NCT04722991
Last Updated: 2025-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2021-03-17
2024-04-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Runcaciguat (BAY1101042)
Runcaciguat (BAY1101042)
Oral dose of runcaciguat
Placebo
Placebo
Oral dose of matching placebo
Interventions
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Runcaciguat (BAY1101042)
Oral dose of runcaciguat
Placebo
Oral dose of matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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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
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
Prague, , Czechia
Všeobecná fakultní nemocnice v Praze
Prague, , Czechia
Axon Clinical, s.r.o.
Prague, , Czechia
Aalborg Universitetshospital - Øjenafdelingen
Aalborg, , Denmark
Aarhus Universitetshospital
Aarhus N, , Denmark
Rigshospitalet Glostrup - Øjensygdomme
Glostrup Municipality, , Denmark
Odense Universitetshospital, Dept of Ophtalmology
Odense C, , Denmark
Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme
Roskilde, , Denmark
NUVISAN GmbH Neu-Ulm
Neu-Ulm, Bavaria, 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
Józefów, , Poland
Klinika Okulistyczna "Jasne Blonia" Sp. z o.o
Lodz, , Poland
Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.
Rzeszów, , Poland
Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski
Tarnowskie Góry, , 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
Banská Bystrica, , Slovakia
Nemocnica Poprad, a.s.
Poprad, , Slovakia
Hospital General de Catalunya
Sant Cugat del Vallès, 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
Seville, , Spain
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
Inselspital Universitätsspital Bern
Bern, , Switzerland
University Eye Hospital Jules Gonin
Lausanne, , Switzerland
Stadtspital Triemli
Zurich, , Switzerland
Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research Group
Gloucester, Gloucestershire, United Kingdom
Sunderland Eye Infirmary
Sunderland, Tyne and Wear, United Kingdom
Bristol Eye Hospital
Bristol, , United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
King's College Hospital NHS Foundation Trust | King's College Hospital - Neurology Department
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
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Other Identifiers
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2020-002333-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20739
Identifier Type: -
Identifier Source: org_study_id
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