Non-proliferative Diabetic Retinopathy Treated With Runcaciguat (NEON-NPDR)

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

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 Overview

• Status: Active, not recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Drug: Runcaciguat (BAY1101042); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • UMHAT Sveti Georgi
  • Plovdiv, Bulgaria, 4001
    • Eye center Sveti Luka
  • Sofia, Bulgaria, 1309
    • SEHAT Pentagram
  • Varna, Bulgaria, 9002
    • Sveta Petka Eye Hospital
• Czechia
  • Pardubice, Czechia, 530 02
    • Ocni klinika Oftex
  • Praha 10, Czechia, 100 34
    • Fakultni nemocnice Kralovske Vinohrady
  • Praha 2, Czechia, 12808
    • Vseobecna fakultni nemocnice v Praze
  • Praha 5, Czechia, 150 00
    • AXON Clinical s.r.o.
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital, Ophtalmology dept.
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital, Skejby
  • Glostrup, Denmark, 2600
    • Glostrup Hospital
  • Odense C, Denmark, 5000
    • Odense Universitetshospital, Dept of Ophtalmology
  • Roskilde, Denmark, 4000
    • Sjællands Universitetshospital Roskilde
• Germany
  • Bayern
    • Neu-Ulm, Bayern, Germany, 89231
      • NUVISAN GmbH Neu-Ulm
• Latvia
  • Riga, Latvia, LV-1006
    • Riga East Clinical University Hospital "Gailezers"
• Netherlands
  • Amsterdam, Netherlands, 1100 DD
    • Academic Medical Center Dept Ophthalmology
  • Nijmegen, Netherlands
    • Universitair Medisch Centrum St. Radboud
  • Tilburg, Netherlands, 5022 GC
    • ETZ Elisabeth Ziekenhuis
• Poland
  • Jozefow, Poland, 05-410
    • Biokinetica S.A
  • Lodz, Poland, 91-134
    • Klinika Okulistyczna "Jasne Blonia" Sp. z o.o
  • Tarnowskie Gory, Poland, 42-600
    • Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski
  • Wroclaw, Poland, 51-162
    • NZOZ Centrum Badan Klinicznych
• Portugal
  • Coimbra, Portugal, 3000-548
    • AIBILI
  • Coimbra, Portugal, 3004-561
    • CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia
  • Porto, Portugal, 4200-319
    • CHUSJ - Hospital Sao Joao
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto
• Romania
  • Cluj-Napoca, Romania, 400006
    • Clinical Emergency County Hospital
• Slovakia
  • Banska Bystrica, Slovakia, 97517
    • Fakultna nemocnica s poliklinikou F.D.Roosevelta
  • Poprad, Slovakia, 058 45
    • Nemocnica Poprad, a.s.
• Spain
  • Barcelona, Spain, 08035
    • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  • Sevilla, Spain, 41071
    • Hospital Universitario Virgen De La Macarena
  • Barcelona
    • Sant Cugat del Vallés, Barcelona, Spain, 08195
      • Hospital General de Catalunya
  • Madrid
    • Coslada, Madrid, Spain, 28822
      • Hospital Universitario de Henares
• Switzerland
  • Lausanne, Switzerland, 1004
    • University Eye Hospital Jules Gonin
• United Kingdom
  • Bristol, United Kingdom, BS12LX
    • Bristol Eye Hospital
  • London, United Kingdom, SE5 9RS
    • King's College Hospital - NHS Foundation Trust
  • London, United Kingdom, EC1V2PD
    • Moorfields Eye Hospital
  • Gloucestershire
    • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
      • Gloucester Royal Infirmary
  • Tyne And Wear
    • Sunderland, Tyne And Wear, United Kingdom, SR29HP
      • Sunderland Eye Infirmary
• United States
  • California
    • Sacramento, California, United States, 95825
      • Retinal Consultants Medical Group, Inc
  • Florida
    • Lakeland, Florida, United States, 33805-2908
      • Florida Retina Consultants
    • Pinellas Park, Florida, United States, 33782
      • Eye Associates of Pinellas
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Mid Atlantic Retina Specialists
    • Hagerstown, Maryland, United States, 21740-5940
      • Cumberland Valley Retina Consultants, PC
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Austin, Texas, United States, 78705-1023
      • Austin Research Center for Retina
    • Bellaire, Texas, United States, 77401
      • Retinal Consultants of Texas - San Antonio
    • McAllen, Texas, United States, 78503
      • Gulf Coast Institute / Valley Retina Institute
    • San Antonio, Texas, United States, 78240
      • Retinal Consultants of Texas - San Antonio
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Oral dose of matching placebo
Experimental: Runcaciguat (BAY1101042)	Drug: Runcaciguat (BAY1101042); Oral dose of runcaciguat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DRSS improvement ≥2 steps at 48 weeks of treatment in the study eye	DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.	At 48 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of treatment emergent adverse events	As reported by Investigators	From first dosing up to 28 days after last dose of study intervention.
Vision threatening complications at 48 weeks of treatment in the study eye		At 48 weeks
DRSS improvement ≥2 steps at 24 weeks of treatment in the study eye	DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.	At 24 weeks

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Estimated): April 25, 2024
• Study Completion (Estimated): April 25, 2024

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Non-proliferative Diabetic Retinopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 20739; 2020-002333-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No