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

Primary Purpose

Diabetic Retinopathy

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Runcaciguat (BAY1101042)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Non-proliferative Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retinal Consultants Medical Group, Inc
  • Florida Retina Consultants
  • Eye Associates of Pinellas
  • Cumberland Valley Retina Consultants, PC
  • Mid Atlantic Retina Specialists
  • Austin Research Center for Retina
  • Austin Retina Associates
  • Retinal Consultants of Texas - San Antonio
  • Gulf Coast Institute / Valley Retina Institute
  • Retinal Consultants of Texas - San Antonio
  • Retina Consultants of Houston
  • UMHAT Sveti Georgi
  • Eye center Sveti Luka
  • SEHAT Pentagram
  • Sveta Petka Eye Hospital
  • Ocni klinika Oftex
  • Fakultni nemocnice Kralovske Vinohrady
  • Vseobecna fakultni nemocnice v Praze
  • AXON Clinical s.r.o.
  • Aalborg Universitetshospital, Ophtalmology dept.
  • Aarhus Universitetshospital, Skejby
  • Glostrup Hospital
  • Odense Universitetshospital, Dept of Ophtalmology
  • Sjællands Universitetshospital Roskilde
  • NUVISAN GmbH Neu-Ulm
  • Riga East Clinical University Hospital "Gailezers"
  • Academic Medical Center Dept Ophthalmology
  • Universitair Medisch Centrum St. Radboud
  • ETZ Elisabeth Ziekenhuis
  • Biokinetica S.A
  • Klinika Okulistyczna "Jasne Blonia" Sp. z o.o
  • Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski
  • NZOZ Centrum Badan Klinicznych
  • AIBILI
  • CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia
  • Centro Hospitalar Universitario do Porto
  • CHUSJ - Hospital Sao Joao
  • Clinical Emergency County Hospital
  • Fakultna Nemocnica s poliklinikou F.D.Roosevelta
  • Nemocnica Poprad, a.s.
  • Hospital General de Catalunya
  • Hospital Universitario de Henares
  • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
  • Hospital Universitario Virgen de la Macarena
  • University Eye Hospital Jules Gonin
  • Gloucester Royal Infirmary
  • Sunderland Eye Infirmary
  • Bristol Eye Hospital
  • Moorfields Eye Hospital
  • King's College Hospital - NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Runcaciguat (BAY1101042)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Vision threatening complications at 48 weeks of treatment in the study eye
DRSS improvement ≥2 steps at 24 weeks of treatment in the study eye
DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.
Frequency of treatment emergent adverse events
As reported by Investigators

Full Information

First Posted
January 22, 2021
Last Updated
September 21, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04722991
Brief Title
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
Acronym
NEON-NPDR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
April 25, 2024 (Anticipated)
Study Completion Date
April 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Non-proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-masked study
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Runcaciguat (BAY1101042)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Runcaciguat (BAY1101042)
Intervention Description
Oral dose of runcaciguat
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral dose of matching placebo
Primary Outcome Measure Information:
Title
DRSS improvement ≥2 steps at 48 weeks of treatment in the study eye
Description
DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.
Time Frame
At 48 weeks of treatment
Secondary Outcome Measure Information:
Title
Vision threatening complications at 48 weeks of treatment in the study eye
Time Frame
At 48 weeks
Title
DRSS improvement ≥2 steps at 24 weeks of treatment in the study eye
Description
DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.
Time Frame
At 24 weeks
Title
Frequency of treatment emergent adverse events
Description
As reported by Investigators
Time Frame
From first dosing up to 28 days after last dose of study intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Retinal Consultants Medical Group, Inc
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Florida Retina Consultants
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805-2908
Country
United States
Facility Name
Eye Associates of Pinellas
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Cumberland Valley Retina Consultants, PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740-5940
Country
United States
Facility Name
Mid Atlantic Retina Specialists
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Austin Research Center for Retina
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-1023
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retinal Consultants of Texas - San Antonio
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Gulf Coast Institute / Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Retinal Consultants of Texas - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
UMHAT Sveti Georgi
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Eye center Sveti Luka
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
SEHAT Pentagram
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Sveta Petka Eye Hospital
City
Varna
ZIP/Postal Code
9002
Country
Bulgaria
Facility Name
Ocni klinika Oftex
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
AXON Clinical s.r.o.
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Aalborg Universitetshospital, Ophtalmology dept.
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus Universitetshospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Odense Universitetshospital, Dept of Ophtalmology
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sjællands Universitetshospital Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
NUVISAN GmbH Neu-Ulm
City
Neu-Ulm
State/Province
Bayern
ZIP/Postal Code
89231
Country
Germany
Facility Name
Riga East Clinical University Hospital "Gailezers"
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
Academic Medical Center Dept Ophthalmology
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
Universitair Medisch Centrum St. Radboud
City
Nijmegen
Country
Netherlands
Facility Name
ETZ Elisabeth Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Biokinetica S.A
City
Jozefow
ZIP/Postal Code
05-410
Country
Poland
Facility Name
Klinika Okulistyczna "Jasne Blonia" Sp. z o.o
City
Lodz
ZIP/Postal Code
91-134
Country
Poland
Facility Name
Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski
City
Tarnowskie Gory
ZIP/Postal Code
42-600
Country
Poland
Facility Name
NZOZ Centrum Badan Klinicznych
City
Wroclaw
ZIP/Postal Code
51-162
Country
Poland
Facility Name
AIBILI
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Facility Name
CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia
City
Coimbra
ZIP/Postal Code
3004-561
Country
Portugal
Facility Name
Centro Hospitalar Universitario do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
CHUSJ - Hospital Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Clinical Emergency County Hospital
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Fakultna Nemocnica s poliklinikou F.D.Roosevelta
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
Facility Name
Nemocnica Poprad, a.s.
City
Poprad
ZIP/Postal Code
058 45
Country
Slovakia
Facility Name
Hospital General de Catalunya
City
Sant Cugat del Vallés
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital Universitario de Henares
City
Coslada
State/Province
Madrid
ZIP/Postal Code
28822
Country
Spain
Facility Name
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
University Eye Hospital Jules Gonin
City
Lausanne
ZIP/Postal Code
1004
Country
Switzerland
Facility Name
Gloucester Royal Infirmary
City
Gloucester
State/Province
Gloucestershire
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
Sunderland Eye Infirmary
City
Sunderland
State/Province
Tyne And Wear
ZIP/Postal Code
SR29HP
Country
United Kingdom
Facility Name
Bristol Eye Hospital
City
Bristol
ZIP/Postal Code
BS12LX
Country
United Kingdom
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V2PD
Country
United Kingdom
Facility Name
King's College Hospital - NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://clinicaltrials.bayer.com/
Description
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.

Learn more about this trial

Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

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