Trial Condition(s):
Diabetic Retinopathy
Non-proliferative diabetic retinopathy treated with runcaciguat (NEON-NPDR)
Bayer Identifier:
20739
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations NUVISAN GmbH Neu-Ulm Neu-Ulm, Germany, 89231 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Odense Universitetshospital, Dept of Ophtalmology Odense C, Denmark, 5000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme Roskilde, Denmark, 4000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rigshospitalet Glostrup - Øjensygdomme Glostrup, Denmark, 2600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aalborg Universitetshospital - Øjenafdelingen Aalborg, Denmark, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus Universitetshospital Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Biokinetica S.A Jozefow, Poland, 05-410 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ Centrum Badan Klinicznych Wroclaw, Poland, 51-162 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia Coimbra, Portugal, 3004-561 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gloucestershire Royal Hospital Gloucester, United Kingdom, GL1 3NN | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sunderland Eye Infirmary Sunderland, United Kingdom, SR29HP | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Moorfields Eye Hospital London, United Kingdom, EC1V2PD | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bristol Eye Hospital Bristol, United Kingdom, BS12LX | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vseobecna fakultni nemocnice v Praze Praha 2, Czech Republic, 128 08 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 100 34 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsspital Basel Basel, Switzerland, 4056 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Eye Hospital Jules Gonin Lausanne, Switzerland, 1004 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stadtspital Triemli Zürich, Switzerland, 8063 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inselspital Universitätsspital Bern Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations King's College Hospital - NHS Foundation Trust London, United Kingdom, SE5 9RS | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AXON Clinical s.r.o. Praha 5, Czech Republic, 150 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academic Medical Center Dept Ophthalmology Amsterdam, Netherlands, 1081HV | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ETZ Elisabeth Ziekenhuis TILBURG, Netherlands, 5022GC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de la Macarena Sevilla, Spain, 41071 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General de Catalunya Sant Cugat del Valles, Spain, 08195 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario del Henares Coslada, Spain, 28822 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AIBILI Coimbra, Portugal, 3000-548 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos Porto, Portugal, 4200-319 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o. Rzeszow, Poland, 35-017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinika Okulistyczna "Jasne Blonia" Sp. z o.o Lodz, Poland, 91-134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski Tarnowskie Gory, Poland, 42-600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnica Poprad, a.s. Poprad, Slovakia, 058 45 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna Nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica, Slovakia, 97517 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gulf Coast Institute / Valley Retina Institute McAllen, United States, 78503 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Retina Consultants Lakeland, United States, 33805-2908 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Research Center for Retina Austin, United States, 78705-1023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Texas - The Woodlands The Woodlands, United States, 77384 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Riga East University Hospital, Bikernieki, Ophthalmology Clinic Riga, Latvia, LV1006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Emergency County Hospital Cluj-Napoca, Romania, 400347 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ocni klinika Oftex Pardubice, Czech Republic, 530 02 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Sveti Georgi Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye center Sveti Luka Plovdiv, Bulgaria, 4001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sveta Petka Eye Hospital Varna, Bulgaria, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SEHAT Pentagram Sofia, Bulgaria, 1309 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cumberland Valley Retina Consultants | Hagerstown, MD Hagerstown, United States, 21740 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retinal Consultants of Texas - San Antonio San Antonio, United States, 78240 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Retina Associates - Central Austin, United States, 78705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retinal Consultants Medical Group, Inc Modesto, United States, 95256 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye Associates of Pinellas Pinellas Park, United States, 33782 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mid Atlantic Retina Specialists Hagerstown, United States, 21740 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retinal Consultants of Texas - Bellaire Bellaire, United States, 77401 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- DRSS improvement ≥2 steps at 48 weeks of treatment in the study eyeDRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.Timeframe: At 48 weeks of treatment
Secondary Outcome
- Vision threatening complications at 48 weeks of treatment in the study eyeTimeframe: At 48 weeks
- DRSS improvement ≥2 steps at 24 weeks of treatment in the study eyeDRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.Timeframe: At 24 weeks
- DRSS improvement ≥ 3 steps at 48 weeks of treatment on the scale for personsThis secondary endpoint is pre-specified in the Statistical Analysis Plan (SAP) Version 3.0.Timeframe: At 48 weeks
- Frequency of treatment emergent adverse eventsAs reported by InvestigatorsTimeframe: From first dosing up to 28 days after last dose of study intervention.
Additional Information
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