Clinical trial NCT04722991: Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Keywords: Non-proliferative Diabetic Retinopathy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-01-25
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye
timeFrame: At 48 weeks of treatment
Secondary outcomes:
measure: Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye
timeFrame: At 48 weeks
measure: Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye
timeFrame: At 24 weeks of treatment
measure: Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale
timeFrame: At 48 weeks of treatment
measure: Number of Participants With Treatment Emergent Adverse Event (TEAE)
timeFrame: From first dosing up to 28 days after last dose of study intervention
Other outcomes:
measure: Percentage of Participants With < 3 Steps Deterioration in DRSS at 48 Weeks of Treatment on the for Persons Scale
timeFrame: At 48 weeks of treatment
Locations:
city: Modesto
country: United States
facility: Retinal Consultants Medical Group, Inc
state: California
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Pinellas Park
country: United States
facility: Eye Associates of Pinellas
state: Florida
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants | Hagerstown, MD
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists - Hagerstown
state: Maryland
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates - Central
state: Texas
city: Bellaire
country: United States
facility: Retinal Consultants of Texas - Bellaire
state: Texas
city: McAllen
country: United States
facility: Gulf Coast Eye Institute / Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of Texas - San Antonio
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas - The Woodlands
state: Texas
city: Plovdiv
country: Bulgaria
facility: Eye center Sveti Luka
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi
city: Sofia
country: Bulgaria
facility: SEHAT Pentagram
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria
city: Varna
country: Bulgaria
facility: Sveta Petka Eye Hospital
city: Pardubice
country: Czechia
facility: Ocni klinika Oftex
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze
city: Praha 5
country: Czechia
facility: Axon Clinical, s.r.o.
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital - Øjenafdelingen
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup - Øjensygdomme
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Dept of Ophtalmology
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme
city: Neu-Ulm
country: Germany
facility: NUVISAN GmbH Neu-Ulm
state: Bayern
city: Riga
country: Latvia
facility: Riga East University Hospital, Bikernieki, Ophthalmology Clinic
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Dept Ophthalmology
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum St. Radboud
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth Ziekenhuis
city: Jozefow
country: Poland
facility: Biokinetica S.A
city: Lodz
country: Poland
facility: Klinika Okulistyczna "Jasne Blonia" Sp. z o.o
city: Rzeszow
country: Poland
facility: Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.
city: Tarnowskie Gory
country: Poland
facility: Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski
city: Wroclaw
country: Poland
facility: NZOZ Centrum Badan Klinicznych
city: Coimbra
country: Portugal
facility: AIBILI
city: Coimbra
country: Portugal
facility: CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos
city: Cluj-Napoca
country: Romania
facility: Clinical Emergency County Hospital
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocnica s poliklinikou F.D.Roosevelta
city: Poprad
country: Slovakia
facility: Nemocnica Poprad, a.s.
city: Sant Cugat del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Coslada
country: Spain
facility: Hospital Universitario del Henares
state: Madrid
city: Barcelona
country: Spain
facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel-Stadt
city: Bern
country: Switzerland
facility: Inselspital Universitätsspital Bern
city: Lausanne
country: Switzerland
facility: University Eye Hospital Jules Gonin
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
city: Gloucester
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research Group
state: Gloucestershire
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
state: Tyne And Wear
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust | King's College Hospital - Neurology Department
Study officials:
References: