check_circleStudy Completed

Diabetic Retinopathy

Non-proliferative diabetic retinopathy treated with runcaciguat

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • Main :
    - 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
  • - 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

Trial summary

Enrollment Goal
109
Trial Dates
March 2021 - April 2024
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Runcaciguat (BAY1101042)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
SocraTec R&D GmbHErfurt, 99084, Germany
Completed
NUVISAN GmbH Neu-UlmNeu-Ulm, 89231, Germany
Withdrawn
Augenzentrum am St. Franziskus-HospitalMünster, 48145, Germany
Withdrawn
Makula-Netzhaut-Zentrum OberkasselDüsseldorf, 40549, Germany
Completed
Odense Universitetshospital, Dept of OphtalmologyOdense C, 5000, Denmark
Completed
Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdommeRoskilde, 4000, Denmark
Completed
Rigshospitalet Glostrup - ØjensygdommeGlostrup, 2600, Denmark
Completed
Aalborg Universitetshospital - ØjenafdelingenAalborg, 9000, Denmark
Completed
Aarhus UniversitetshospitalAarhus N, 8200, Denmark
Completed
Biokinetica S.AJozefow, 05-410, Poland
Completed
NZOZ Centrum Badan KlinicznychWroclaw, 51-162, Poland
Withdrawn
IRCCS Fondazione G.B. Bietti Studio e Ricerca in OtalmologiaRoma, 00198, Italy
Withdrawn
Ospedale San Raffaele s.r.l.Milano, 20132, Italy
Withdrawn
ASST Fatebenefratelli SaccoMilano, 20157, Italy
Withdrawn
A.O.U. di CagliariCagliari, 09124, Italy
Withdrawn
A.O.U. di PadovaPadova, 35128, Italy
Completed
CHUC - Hospitais da U. Coimbra - Servico de OftalmologiaCoimbra, 3004-561, Portugal
Completed
Centro Hospitalar Universitario do PortoPorto, 4099-001, Portugal
Withdrawn
Hospital de Vila Franca de Xira | Centro de Desenvolvimento e InvestigacaoVila Franca de Xira, 2600-178, Portugal
Completed
Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research GroupGloucester, GL1 3NN, United Kingdom
Completed
Sunderland Eye InfirmarySunderland, SR29HP, United Kingdom
Completed
Moorfields Eye HospitalLondon, EC1V2PD, United Kingdom
Completed
Bristol Eye HospitalBristol, BS12LX, United Kingdom
Withdrawn
Fakultni nemocnice OstravaOstrava, 708 52, Czechia
Completed
Všeobecná fakultní nemocnice v PrazePraha 2, 128 08, Czech Republic
Completed
Fakultni nemocnice Kralovske VinohradyPraha 10, 100 34, Czech Republic
Withdrawn
Fakultni nemocnice BrnoBrno, 625 00, Czechia
Completed
Universitätsspital BaselBasel, 4056, Switzerland
Completed
University Eye Hospital Jules GoninLausanne, 1004, Switzerland
Completed
Stadtspital TriemliZürich, 8063, Switzerland
Completed
Inselspital Universitätsspital BernBern, 3010, Switzerland
Completed
King’s College Hospital NHS Foundation Trust | King's College Hospital - Neurology DepartmentLondon, SE5 9RS, United Kingdom
Withdrawn
Krajska Nemocnice LiberecLiberec, 460 63, Czech Republic
Completed
Axon Clinical, s.r.o.Praha 5, 150 00, Czech Republic
Completed
Academic Medical Center Dept OphthalmologyAmsterdam, 1081HV, Netherlands
Withdrawn
VUmcAMSTERDAM, 1081 HV, Netherlands
Completed
Universitair Medisch Centrum St. RadboudNIJMEGEN, 6525 GA, Netherlands
Completed
ETZ Elisabeth ZiekenhuisTILBURG, 5022GC, Netherlands
Withdrawn
OogziekenhuisROTTERDAM, 3011 BH, Netherlands
Completed
Hospital Universitario Virgen de la MacarenaSevilla, 41071, Spain
Completed
Ciutat Sanitaria i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital General de CatalunyaSant Cugat del Valles, 08195, Spain
Withdrawn
Instituto de Salud Carlos IIIMadrid, 28029, Spain
Completed
Hospital Universitario del HenaresCoslada, 28822, Spain
Completed
AIBILICoimbra, 3000-548, Portugal
Completed
Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios ClinicosPorto, 4200-319, Portugal
Withdrawn
Universitair Medisch Centrum GroningenGroningen, 9713 GZ, Netherlands
Withdrawn
Ophthal sp. z o.o.Lublin, 20-567, Poland
Completed
Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.Rzeszow, 35-017, Poland
Completed
Klinika Okulistyczna "Jasne Blonia" Sp. z o.oLodz, 91-134, Poland
Withdrawn
Magyar Honvedseg Egeszsegugyi KozpontBudapest, 1062, Hungary
Withdrawn
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és SzakrendeloBudapest, 1125, Hungary
Withdrawn
Budapesti Peterfy Sandor utcai Korhaz-RendelointezetBudapest, 1076, Hungary
Withdrawn
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Withdrawn
Leids Universitair Medisch CentrumLEIDEN, 2333 ZA, Netherlands
Withdrawn
Budapest Retina AssociatesBudapest, 1133, Hungary
Withdrawn
Ganglion Medical CenterPecs, 7621, Hungary
Completed
Ind. Spec. Prakt. Lek. Dr W. JedrzejewskiTarnowskie Gory, 42-600, Poland
Withdrawn
CHEDV - Hospital Sao SebastiaoSanta Maria da Feira, 4520-211, Portugal
Withdrawn
Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research CenterLisboa, 1350-352, Portugal
Completed
Nemocnica Poprad, a.s.Poprad, 058 45, Slovakia
Withdrawn
Fakultna nemocnica s poliklinikou ZilinaZilina, 012 07, Slovakia
Completed
Fakultna Nemocnica s poliklinikou F.D.RooseveltaBanska Bystrica, 97517, Slovakia
Withdrawn
Clinique d’ophtalmologie des LaurentidesBoisbrand, J7H 0E8, Canada
Completed
Gulf Coast Eye Institute / Valley Retina InstituteMcAllen, 78503, United States
Completed
Florida Retina ConsultantsLakeland, 33805, United States
Completed
Austin Research Center for RetinaAustin, 78705-1023, United States
Completed
Retina Consultants of Texas - The WoodlandsThe Woodlands, 77384, United States
Completed
Riga East University Hospital, Bikernieki, Ophthalmology ClinicRiga, LV1006, Latvia
Withdrawn
S.C. ONIOPTIC MEDICAL PD SRLCraiova, TBC, Romania
Completed
Clinical Emergency County HospitalCluj-Napoca, 400347, Romania
Completed
Ocni klinika OftexPardubice, 530 02, Czech Republic
Completed
Diagnostic-Consultative Center Alexandrovska | Sofia, BulgariaSofia, 1431, Bulgaria
Completed
UMHAT Sveti GeorgiPlovdiv, 4002, Bulgaria
Completed
Eye center Sveti LukaPlovdiv, 4001, Bulgaria
Completed
Sveta Petka Eye HospitalVarna, 9000, Bulgaria
Completed
SEHAT PentagramSofia, 1309, Bulgaria
Completed
Cumberland Valley Retina Consultants | Hagerstown, MDHagerstown, 21740, United States
Completed
Retinal Consultants of Texas - San AntonioSan Antonio, 78240, United States
Completed
Austin Retina Associates - CentralAustin, 78705, United States
Withdrawn
Palmetto Retina Center, LLC - FlorenceFlorence, 29501, United States
Completed
Retinal Consultants Medical Group, IncModesto, 95256, United States
Withdrawn
Retina Consultants of Southern CaliforniaRedlands, 92374, United States
Completed
Eye Associates of PinellasPinellas Park, 33782, United States
Completed
Mid Atlantic Retina Specialists - HagerstownHagerstown, 21740, United States
Completed
Retinal Consultants of Texas - BellaireBellaire, 77401, United States

Primary Outcome

  • Percentage of participants with improvement in DRSS by ≥ 2 steps at 48 weeks of treatment in the study eye
    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
    date_rangeTime Frame:
    At 48 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage participants with vision threatening complications (VTC) at 48 weeks of treatment in the study eye
    VTC are defined as occurrence of any of the following AEs: • Proliferative diabetic retinopathy (PDR) (DRSS ≥61) • Any ocular neo-vascularization (retinal or anterior-segment neovascularization) • Center-involved (central Early Treatment Diabetic Retinopathy Study [ETDRS] subfield) DME • Drop of Best corrected visual acuity (BCVA) of 10 letters or more from baseline
    date_rangeTime Frame:
    At 48 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with ≥ 2 steps improvement in DRSS at 24 weeks of treatment in the study eye
    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
    date_rangeTime Frame:
    At 24 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with ≥ 3 steps improvement in DRSS at 48 weeks of treatment on the for persons scale
    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
    date_rangeTime Frame:
    At 48 weeks of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with treatment emergent adverse event (TEAE)
    date_rangeTime Frame:
    From first dosing up to 28 days after last dose of study intervention
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2