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 | Status | |
|---|---|---|
Locations NUVISAN GmbH Neu-Ulm Neu-Ulm, Germany, 89231 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Odense Universitetshospital, Dept of Ophtalmology Odense C, Denmark, 5000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sjællands Universitetshospital Roskilde Roskilde, Denmark, 4000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Glostrup Hospital Glostrup, Denmark, 2600 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aalborg Universitetshospital, Ophtalmology dept. Aalborg, Denmark, 9000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Biokinetica S.A Jozefow, Poland, 05-410 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ Centrum Badan Klinicznych Wroclaw, Poland, 51-162 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia Coimbra, Portugal, 3004-561 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitario do Porto Porto, Portugal, 4099-001 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gloucester Royal Infirmary Gloucester, United Kingdom, GL1 3NN | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sunderland Eye Infirmary Sunderland, United Kingdom, SR2 9HP | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Moorfields Eye Hospital London, United Kingdom, EC1V 2PD | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bristol Eye Hospital Bristol, United Kingdom, BS1 2LX | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vseobecna fakultni nemocnice v Praze Praha 2, Czech Republic, 12808 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Kralovske Vinohrady Praha 10, Czech Republic, 100 34 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsspital Basel Basel, Switzerland, 4056 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Eye Hospital Jules Gonin Lausanne, Switzerland, 1004 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stadtspital Triemli Zürich, Switzerland, 8063 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inselspital Universitätsspital Bern Bern, Switzerland, 3010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations King's College Hospital - NHS Foundation Trust London, United Kingdom, SE5 9RS | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krajska Nemocnice Liberec Liberec, Czech Republic, 460 63 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AXON Clinical s.r.o. Praha 5, Czech Republic, 150 00 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academic Medical Center Dept Ophthalmology Amsterdam, Netherlands, 1100 DD | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ETZ Elisabeth Ziekenhuis Tilburg, Netherlands, 5022 GC | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de la Macarena Sevilla, Spain, 41071 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General de Catalunya Sant Cugat del Vallés, Spain, 08195 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario de Henares Coslada, Spain, 28822 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AIBILI Coimbra, Portugal, 3000-548 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUSJ - Hospital Sao Joao Porto, Portugal, 4200-319 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitair Medisch Centrum Groningen Groningen, Netherlands, 9713 GZ | Status Not yet recruiting | 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 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinika Okulistyczna "Jasne Blonia" Sp. z o.o Lodz, Poland, 91-134 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Leids Universitair Medisch Centrum LEIDEN, Netherlands, 2333 ZA | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski Tarnowskie Gory, Poland, 42-600 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHEDV - Hospital Sao Sebastiao Santa Maria da Feira, Portugal, 4520-211 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnica Poprad, a.s. Poprad, Slovakia, 058 45 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultna Nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica, Slovakia, 97517 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gulf Coast Institute / Valley Retina Institute McAllen, United States, 78503 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Florida Retina Consultants Lakeland, United States, 33805 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Research Center for Retina Austin, United States, 78705 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retina Consultants of Houston The Woodlands, United States, 77384 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Riga East Clinical University Hospital "Gailezers" Riga, Latvia, LV-1006 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations S.C. ONIOPTIC MEDICAL PD SRL Craiova, Romania | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Emergency County Hospital Cluj-Napoca, Romania, 400006 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ocni klinika Oftex Pardubice, Czech Republic, 530 02 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DCC Aleksandrovska Sofia, Bulgaria, 1431 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Sveti Georgi Plovdiv, Bulgaria, 4000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye center Sveti Luka Plovdiv, Bulgaria, 4001 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sveta Petka Eye Hospital Varna, Bulgaria, 9002 | Status Recruiting | Contact Us: E-mail: [email protected]com Phone: (+)1-888-84 22937 |
Locations SEHAT Pentagram Sofia, Bulgaria, 1309 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cumberland Valley Retina Consultants, PC Hagerstown, United States, 21740 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retinal Consultants of Texas - San Antonio San Antonio, United States, 78240 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Retina Associates Austin, United States, 78705 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Palmetto Retina Center, LLC - Florence Florence, United States, 29501 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retinal Consultants Medical Group, Inc Sacramento, United States, 95825 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eye Associates of Pinellas Pinellas Park, United States, 33782 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mid Atlantic Retina Specialists Hagerstown, United States, 21740 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Retinal Consultants of Texas - San Antonio Bellaire, United States, 77401 | Status Recruiting | 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
- 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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