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
- Diseases
- Diabetic eye disease
- 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
Sites (55)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMHAT Sveti Georgi Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| Eye center Sveti Luka Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| SEHAT Pentagram Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Sveta Petka Eye Hospital Coordinator of this site? Confirm its status | Varna | Bulgaria | Unknown status |
| Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Universitätsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| University Eye Hospital Jules Gonin Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Stadtspital Triemli Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Ocni klinika Oftex Coordinator of this site? Confirm its status | Pardubice | Czechia | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Axon Clinical s.r.o. Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| NUVISAN GmbH Neu-Ulm Coordinator of this site? Confirm its status | Neu-Ulm | Germany | Unknown status |
| Aalborg Universitetshospital - Øjenafdelingen Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
| Rigshospitalet Glostrup - Øjensygdomme Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
| Odense Universitetshospital, Dept of Ophtalmology Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
| Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme Coordinator of this site? Confirm its status | Roskilde | Denmark | Unknown status |
| Ciutat Sanitaria i Universitaria de la Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Del Henares Coordinator of this site? Confirm its status | Coslada | Spain | Unknown status |
| Hospital General De Catalunya Coordinator of this site? Confirm its status | Sant Cugat del Vallès | Spain | Unknown status |
| Hospital Universitario Virgen de la Macarena Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Bristol Eye Hospital Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research Group Coordinator of this site? Confirm its status | Gloucester | United Kingdom | Unknown status |
| King's College Hospital NHS Foundation Trust | King's College Hospital - Neurology Department Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Moorfields Eye Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Sunderland Eye Infirmary Coordinator of this site? Confirm its status | Sunderland | United Kingdom | Unknown status |
| Riga East University Hospital, Bikernieki, Ophthalmology Clinic Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| Academic Medical Center Dept Ophthalmology Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Universitair Medisch Centrum St. Radboud Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| ETZ Elisabeth ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Unknown status |
| Biokinetica S.A. Coordinator of this site? Confirm its status | Jozefow | Poland | Unknown status |
| Klinika Okulistyczna Jasne Blonia sp. z o.o Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Ośrodek Chirurgii Oka Prof. Zagórskiego Sp. Z o.o. Coordinator of this site? Confirm its status | Rzeszów | Poland | Unknown status |
| Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski Coordinator of this site? Confirm its status | Tarnowskie Góry | Poland | Unknown status |
| NZOZ Centrum Badan Klinicznych Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| AIBILI Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
| Centro Hospitalar Universitario do Porto Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos Coordinator of this site? Confirm its status | Porto | Portugal | Unknown status |
| Clinical Emergency County Hospital Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Fakultna nemocnica s poliklinikou F.D.Roosevelta Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Unknown status |
| Nemocnica Poprad, a.s. Coordinator of this site? Confirm its status | Poprad | Slovakia | Unknown status |
| Austin Research Center for Retina Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Austin Retina Associates - Central Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Retinal Consultants of Texas - Bellaire Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Cumberland Valley Retina Consultants | Hagerstown, MD Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Mid Atlantic Retina Specialists - Hagerstown Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Florida Retina Consultants Coordinator of this site? Confirm its status | Lakeland | United States | Unknown status |
| Gulf Coast Eye Institute / Valley Retina Institute Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| Retinal Consultants Medical Group, Inc Coordinator of this site? Confirm its status | Modesto | United States | Unknown status |
| Eye Associates of Pinellas Coordinator of this site? Confirm its status | Pinellas Park | United States | Unknown status |
| Retinal Consultants of Texas- San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Retina Consultants of Texas - The Woodlands Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.