Fact CheckerSign in

NCT04722991CompletedPhase 2

Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

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

Source: ClinicalTrials.gov · Last updated 8 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
109 (actual)
First submitted
22 Jan 2021
Start date
Mar 2021
Primary completion date
Mar 2024
Lead sponsor
Bayer
NCT number
NCT04722991
EudraCT number
2020-002333-15

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 109
  • From Mar 2021 to the primary completion date, Mar 2024
  • 55 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (55)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UMHAT Sveti Georgi
Coordinator of this site? Confirm its status
PlovdivBulgariaUnknown status
Eye center Sveti Luka
Coordinator of this site? Confirm its status
PlovdivBulgariaUnknown status
SEHAT Pentagram
Coordinator of this site? Confirm its status
SofiaBulgariaUnknown status
Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria
Coordinator of this site? Confirm its status
SofiaBulgariaUnknown status
Sveta Petka Eye Hospital
Coordinator of this site? Confirm its status
VarnaBulgariaUnknown status
Universitätsspital Basel
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status
Inselspital Universitätsspital Bern
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
University Eye Hospital Jules Gonin
Coordinator of this site? Confirm its status
LausanneSwitzerlandUnknown status
Stadtspital Triemli
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status
Ocni klinika Oftex
Coordinator of this site? Confirm its status
PardubiceCzechiaUnknown status
Vseobecna fakultni nemocnice v Praze
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
Axon Clinical s.r.o.
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
Fakultni nemocnice Kralovske Vinohrady
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
NUVISAN GmbH Neu-Ulm
Coordinator of this site? Confirm its status
Neu-UlmGermanyUnknown status
Aalborg Universitetshospital - Øjenafdelingen
Coordinator of this site? Confirm its status
AalborgDenmarkUnknown status
Aarhus Universitetshospital
Coordinator of this site? Confirm its status
Aarhus NDenmarkUnknown status
Rigshospitalet Glostrup - Øjensygdomme
Coordinator of this site? Confirm its status
Glostrup MunicipalityDenmarkUnknown status
Odense Universitetshospital, Dept of Ophtalmology
Coordinator of this site? Confirm its status
Odense CDenmarkUnknown status
Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme
Coordinator of this site? Confirm its status
RoskildeDenmarkUnknown status
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hospital Universitario Del Henares
Coordinator of this site? Confirm its status
CosladaSpainUnknown status
Hospital General De Catalunya
Coordinator of this site? Confirm its status
Sant Cugat del VallèsSpainUnknown status
Hospital Universitario Virgen de la Macarena
Coordinator of this site? Confirm its status
SevilleSpainUnknown status
Bristol Eye Hospital
Coordinator of this site? Confirm its status
BristolUnited KingdomUnknown status
Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research Group
Coordinator of this site? Confirm its status
GloucesterUnited KingdomUnknown status
King's College Hospital NHS Foundation Trust | King's College Hospital - Neurology Department
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Moorfields Eye Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Sunderland Eye Infirmary
Coordinator of this site? Confirm its status
SunderlandUnited KingdomUnknown status
Riga East University Hospital, Bikernieki, Ophthalmology Clinic
Coordinator of this site? Confirm its status
RigaLatviaUnknown status
Academic Medical Center Dept Ophthalmology
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
Universitair Medisch Centrum St. Radboud
Coordinator of this site? Confirm its status
NijmegenNetherlandsUnknown status
ETZ Elisabeth ziekenhuis
Coordinator of this site? Confirm its status
TilburgNetherlandsUnknown status
Biokinetica S.A.
Coordinator of this site? Confirm its status
JozefowPolandUnknown status
Klinika Okulistyczna Jasne Blonia sp. z o.o
Coordinator of this site? Confirm its status
LodzPolandUnknown status
Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o.
Coordinator of this site? Confirm its status
RzeszówPolandUnknown status
Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski
Coordinator of this site? Confirm its status
Tarnowskie GóryPolandUnknown status
NZOZ Centrum Badan Klinicznych
Coordinator of this site? Confirm its status
WroclawPolandUnknown status
CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia
Coordinator of this site? Confirm its status
CoimbraPortugalUnknown status
AIBILI
Coordinator of this site? Confirm its status
CoimbraPortugalUnknown status
Centro Hospitalar Universitario do Porto
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
Clinical Emergency County Hospital
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaUnknown status
Fakultna nemocnica s poliklinikou F.D.Roosevelta
Coordinator of this site? Confirm its status
Banská BystricaSlovakiaUnknown status
Nemocnica Poprad, a.s.
Coordinator of this site? Confirm its status
PopradSlovakiaUnknown status
Austin Research Center for Retina
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Austin Retina Associates - Central
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Retinal Consultants of Texas - Bellaire
Coordinator of this site? Confirm its status
BellaireUnited StatesUnknown status
Cumberland Valley Retina Consultants | Hagerstown, MD
Coordinator of this site? Confirm its status
HagerstownUnited StatesUnknown status
Mid Atlantic Retina Specialists - Hagerstown
Coordinator of this site? Confirm its status
HagerstownUnited StatesUnknown status
Florida Retina Consultants
Coordinator of this site? Confirm its status
LakelandUnited StatesUnknown status
Gulf Coast Eye Institute / Valley Retina Institute
Coordinator of this site? Confirm its status
McAllenUnited StatesUnknown status
Retinal Consultants Medical Group, Inc
Coordinator of this site? Confirm its status
ModestoUnited StatesUnknown status
Eye Associates of Pinellas
Coordinator of this site? Confirm its status
Pinellas ParkUnited StatesUnknown status
Retinal Consultants of Texas- San Antonio
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Retina Consultants of Texas - The Woodlands
Coordinator of this site? Confirm its status
The WoodlandsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.