check_circleStudy Completed
Diabetic Retinopathy
Bayer Identifier:
20739
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
AllAge
18 - N/ATrial summary
Enrollment Goal
109Trial Dates
March 2021 - April 2024Phase
Phase 2Could I Receive a placebo
YesProducts
Runcaciguat (BAY1101042)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | SocraTec R&D GmbH | Erfurt, 99084, Germany |
Completed | NUVISAN GmbH Neu-Ulm | Neu-Ulm, 89231, Germany |
Withdrawn | Augenzentrum am St. Franziskus-Hospital | Münster, 48145, Germany |
Withdrawn | Makula-Netzhaut-Zentrum Oberkassel | Düsseldorf, 40549, Germany |
Completed | Odense Universitetshospital, Dept of Ophtalmology | Odense C, 5000, Denmark |
Completed | Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme | Roskilde, 4000, Denmark |
Completed | Rigshospitalet Glostrup - Øjensygdomme | Glostrup, 2600, Denmark |
Completed | Aalborg Universitetshospital - Øjenafdelingen | Aalborg, 9000, Denmark |
Completed | Aarhus Universitetshospital | Aarhus N, 8200, Denmark |
Completed | Biokinetica S.A | Jozefow, 05-410, Poland |
Completed | NZOZ Centrum Badan Klinicznych | Wroclaw, 51-162, Poland |
Withdrawn | IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia | Roma, 00198, Italy |
Withdrawn | Ospedale San Raffaele s.r.l. | Milano, 20132, Italy |
Withdrawn | ASST Fatebenefratelli Sacco | Milano, 20157, Italy |
Withdrawn | A.O.U. di Cagliari | Cagliari, 09124, Italy |
Withdrawn | A.O.U. di Padova | Padova, 35128, Italy |
Completed | CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia | Coimbra, 3004-561, Portugal |
Completed | Centro Hospitalar Universitario do Porto | Porto, 4099-001, Portugal |
Withdrawn | Hospital de Vila Franca de Xira | Centro de Desenvolvimento e Investigacao | Vila Franca de Xira, 2600-178, Portugal |
Completed | Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research Group | Gloucester, GL1 3NN, United Kingdom |
Completed | Sunderland Eye Infirmary | Sunderland, SR29HP, United Kingdom |
Completed | Moorfields Eye Hospital | London, EC1V2PD, United Kingdom |
Completed | Bristol Eye Hospital | Bristol, BS12LX, United Kingdom |
Withdrawn | Fakultni nemocnice Ostrava | Ostrava, 708 52, Czechia |
Completed | Všeobecná fakultní nemocnice v Praze | Praha 2, 128 08, Czech Republic |
Completed | Fakultni nemocnice Kralovske Vinohrady | Praha 10, 100 34, Czech Republic |
Withdrawn | Fakultni nemocnice Brno | Brno, 625 00, Czechia |
Completed | Universitätsspital Basel | Basel, 4056, Switzerland |
Completed | University Eye Hospital Jules Gonin | Lausanne, 1004, Switzerland |
Completed | Stadtspital Triemli | Zürich, 8063, Switzerland |
Completed | Inselspital Universitätsspital Bern | Bern, 3010, Switzerland |
Completed | King’s College Hospital NHS Foundation Trust | King's College Hospital - Neurology Department | London, SE5 9RS, United Kingdom |
Withdrawn | Krajska Nemocnice Liberec | Liberec, 460 63, Czech Republic |
Completed | Axon Clinical, s.r.o. | Praha 5, 150 00, Czech Republic |
Completed | Academic Medical Center Dept Ophthalmology | Amsterdam, 1081HV, Netherlands |
Withdrawn | VUmc | AMSTERDAM, 1081 HV, Netherlands |
Completed | Universitair Medisch Centrum St. Radboud | NIJMEGEN, 6525 GA, Netherlands |
Completed | ETZ Elisabeth Ziekenhuis | TILBURG, 5022GC, Netherlands |
Withdrawn | Oogziekenhuis | ROTTERDAM, 3011 BH, Netherlands |
Completed | Hospital Universitario Virgen de la Macarena | Sevilla, 41071, Spain |
Completed | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Hospital General de Catalunya | Sant Cugat del Valles, 08195, Spain |
Withdrawn | Instituto de Salud Carlos III | Madrid, 28029, Spain |
Completed | Hospital Universitario del Henares | Coslada, 28822, Spain |
Completed | AIBILI | Coimbra, 3000-548, Portugal |
Completed | Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos | Porto, 4200-319, Portugal |
Withdrawn | Universitair Medisch Centrum Groningen | Groningen, 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.o | Lodz, 91-134, Poland |
Withdrawn | Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, 1062, Hungary |
Withdrawn | Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz és Szakrendelo | Budapest, 1125, Hungary |
Withdrawn | Budapesti Peterfy Sandor utcai Korhaz-Rendelointezet | Budapest, 1076, Hungary |
Withdrawn | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Withdrawn | Leids Universitair Medisch Centrum | LEIDEN, 2333 ZA, Netherlands |
Withdrawn | Budapest Retina Associates | Budapest, 1133, Hungary |
Withdrawn | Ganglion Medical Center | Pecs, 7621, Hungary |
Completed | Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski | Tarnowskie Gory, 42-600, Poland |
Withdrawn | CHEDV - Hospital Sao Sebastiao | Santa Maria da Feira, 4520-211, Portugal |
Withdrawn | Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center | Lisboa, 1350-352, Portugal |
Completed | Nemocnica Poprad, a.s. | Poprad, 058 45, Slovakia |
Withdrawn | Fakultna nemocnica s poliklinikou Zilina | Zilina, 012 07, Slovakia |
Completed | Fakultna Nemocnica s poliklinikou F.D.Roosevelta | Banska Bystrica, 97517, Slovakia |
Withdrawn | Clinique d’ophtalmologie des Laurentides | Boisbrand, J7H 0E8, Canada |
Completed | Gulf Coast Eye Institute / Valley Retina Institute | McAllen, 78503, United States |
Completed | Florida Retina Consultants | Lakeland, 33805, United States |
Completed | Austin Research Center for Retina | Austin, 78705-1023, United States |
Completed | Retina Consultants of Texas - The Woodlands | The Woodlands, 77384, United States |
Completed | Riga East University Hospital, Bikernieki, Ophthalmology Clinic | Riga, LV1006, Latvia |
Withdrawn | S.C. ONIOPTIC MEDICAL PD SRL | Craiova, TBC, Romania |
Completed | Clinical Emergency County Hospital | Cluj-Napoca, 400347, Romania |
Completed | Ocni klinika Oftex | Pardubice, 530 02, Czech Republic |
Completed | Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria | Sofia, 1431, Bulgaria |
Completed | UMHAT Sveti Georgi | Plovdiv, 4002, Bulgaria |
Completed | Eye center Sveti Luka | Plovdiv, 4001, Bulgaria |
Completed | Sveta Petka Eye Hospital | Varna, 9000, Bulgaria |
Completed | SEHAT Pentagram | Sofia, 1309, Bulgaria |
Completed | Cumberland Valley Retina Consultants | Hagerstown, MD | Hagerstown, 21740, United States |
Completed | Retinal Consultants of Texas - San Antonio | San Antonio, 78240, United States |
Completed | Austin Retina Associates - Central | Austin, 78705, United States |
Withdrawn | Palmetto Retina Center, LLC - Florence | Florence, 29501, United States |
Completed | Retinal Consultants Medical Group, Inc | Modesto, 95256, United States |
Withdrawn | Retina Consultants of Southern California | Redlands, 92374, United States |
Completed | Eye Associates of Pinellas | Pinellas Park, 33782, United States |
Completed | Mid Atlantic Retina Specialists - Hagerstown | Hagerstown, 21740, United States |
Completed | Retinal Consultants of Texas - Bellaire | Bellaire, 77401, United States |
Primary Outcome
- Percentage of participants with improvement in DRSS by ≥ 2 steps at 48 weeks of treatment in the study eyeDRSS (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 treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Percentage participants with vision threatening complications (VTC) at 48 weeks of treatment in the study eyeVTC 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 baselinedate_rangeTime Frame:At 48 weeksenhanced_encryptionNoSafety Issue:
- Percentage of participants with ≥ 2 steps improvement in DRSS at 24 weeks of treatment in the study eyeDRSS (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 treatmentenhanced_encryptionNoSafety Issue:
- Percentage of participants with ≥ 3 steps improvement in DRSS at 48 weeks of treatment on the for persons scaleDRSS (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 treatmentenhanced_encryptionNoSafety Issue:
- Number of participants with treatment emergent adverse event (TEAE)date_rangeTime Frame:From first dosing up to 28 days after last dose of study interventionenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2