Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

Diabetic Retinopathy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722991
• Other study ID #: 20739
• Secondary ID: 2020-002333-15
• Status: Completed
• Phase: Phase 2
• Start date: March 17, 2021
• Est. completion date: April 22, 2024

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 22, 2024
• Est. primary completion date: March 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Runcaciguat (BAY1101042)
Oral dose of runcaciguat

Other:
• Placebo
Oral dose of matching placebo

Locations

Country	Name	City	State
Bulgaria	Eye center Sveti Luka	Plovdiv
Bulgaria	UMHAT Sveti Georgi	Plovdiv
Bulgaria	SEHAT Pentagram	Sofia
Bulgaria	Sveta Petka Eye Hospital	Varna
Czechia	Ocni klinika Oftex	Pardubice
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Czechia	AXON Clinical s.r.o.	Praha 5
Denmark	Aalborg Universitetshospital, Ophtalmology dept.	Aalborg
Denmark	Aarhus Universitetshospital, Skejby	Aarhus N
Denmark	Glostrup Hospital	Glostrup
Denmark	Odense Universitetshospital, Dept of Ophtalmology	Odense C
Denmark	Sjællands Universitetshospital Roskilde	Roskilde
Germany	NUVISAN GmbH Neu-Ulm	Neu-Ulm	Bayern
Latvia	Riga East Clinical University Hospital "Gailezers"	Riga
Netherlands	Academic Medical Center Dept Ophthalmology	Amsterdam
Netherlands	Universitair Medisch Centrum St. Radboud	Nijmegen
Netherlands	ETZ Elisabeth Ziekenhuis	Tilburg
Poland	Biokinetica S.A	Jozefow
Poland	Klinika Okulistyczna "Jasne Blonia" Sp. z o.o	Lodz
Poland	Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski	Tarnowskie Gory
Poland	NZOZ Centrum Badan Klinicznych	Wroclaw
Portugal	AIBILI	Coimbra
Portugal	CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia	Coimbra
Portugal	Centro Hospitalar Universitario do Porto	Porto
Portugal	CHUSJ - Hospital Sao Joao	Porto
Romania	Clinical Emergency County Hospital	Cluj-Napoca
Slovakia	Fakultna Nemocnica s poliklinikou F.D.Roosevelta	Banska Bystrica
Slovakia	Nemocnica Poprad, a.s.	Poprad
Spain	Ciutat Sanitaria i Universitaria de la Vall d'Hebron	Barcelona
Spain	Hospital Universitario de Henares	Coslada	Madrid
Spain	Hospital General de Catalunya	Sant Cugat del Vallés	Barcelona
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Switzerland	University Eye Hospital Jules Gonin	Lausanne
United Kingdom	Bristol Eye Hospital	Bristol
United Kingdom	Gloucester Royal Infirmary	Gloucester	Gloucestershire
United Kingdom	King's College Hospital - NHS Foundation Trust	London
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	Sunderland Eye Infirmary	Sunderland	Tyne And Wear
United States	Austin Research Center for Retina	Austin	Texas
United States	Austin Retina Associates	Austin	Texas
United States	Retinal Consultants of Texas - San Antonio	Bellaire	Texas
United States	Cumberland Valley Retina Consultants, PC	Hagerstown	Maryland
United States	Mid Atlantic Retina Specialists	Hagerstown	Maryland
United States	Florida Retina Consultants	Lakeland	Florida
United States	Gulf Coast Institute / Valley Retina Institute	McAllen	Texas
United States	Eye Associates of Pinellas	Pinellas Park	Florida
United States	Retinal Consultants Medical Group, Inc	Sacramento	California
United States	Retinal Consultants of Texas - San Antonio	San Antonio	Texas
United States	Retina Consultants of Houston	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Denmark,  Germany,  Latvia,  Netherlands,  Poland,  Portugal,  Romania,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vision threatening complications at 48 weeks of treatment in the study eye		At 48 weeks
Secondary	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
Secondary	Frequency of treatment emergent adverse events	As reported by Investigators	From first dosing up to 28 days after last dose of study intervention.

External Links

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