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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002333-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Runcaciguat (BAY1101042) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Runcaciguat (BAY1101042) | Drug | Oral dose of runcaciguat |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 48 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With < 3 Steps Deterioration 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. | At 48 weeks of treatment |
Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants Medical Group, Inc | Modesto | California | 95256 | United States | ||
| Florida Retina Consultants |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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Out of the 224 screened participants, 109 participants were randomized and started treatment. 115 participants did not pass screening. The primary reason for screen failure was that one or more inclusion or exclusion criteria were not met by the participant.
The study was conducted at 39 study centers in Europe and US that randomized 109 participants from 17 MAR 2021 (first patient first visit) to 22 APR 2024 (last patient last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Runcacigat (BAY1101042) | Participants received runcaciguat gastrointestinal therapeutic system (GITS) tablets and were treated following an intra-individual dose-titration design with three titration steps. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2023 | Apr 7, 2025 |
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double-masked study
| Placebo |
| Other |
Oral dose of matching placebo |
|
| At 48 weeks |
| 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. | At 24 weeks of treatment |
| 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. | At 48 weeks of treatment |
| Number of Participants With Treatment Emergent Adverse Event (TEAE) | From first dosing up to 28 days after last dose of study intervention |
| Lakeland |
| Florida |
| 33805 |
| United States |
| Eye Associates of Pinellas | Pinellas Park | Florida | 33782 | United States |
| Cumberland Valley Retina Consultants | Hagerstown, MD | Hagerstown | Maryland | 21740 | United States |
| Mid Atlantic Retina Specialists - Hagerstown | Hagerstown | Maryland | 21740 | United States |
| Austin Research Center for Retina | Austin | Texas | 78705-1023 | United States |
| Austin Retina Associates - Central | Austin | Texas | 78705 | United States |
| Retinal Consultants of Texas - Bellaire | Bellaire | Texas | 77401 | United States |
| Gulf Coast Eye Institute / Valley Retina Institute | McAllen | Texas | 78503 | United States |
| Retinal Consultants of Texas - San Antonio | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas - The Woodlands | The Woodlands | Texas | 77384 | United States |
| Eye center Sveti Luka | Plovdiv | 4001 | Bulgaria |
| UMHAT Sveti Georgi | Plovdiv | 4002 | Bulgaria |
| SEHAT Pentagram | Sofia | 1309 | Bulgaria |
| Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria | Sofia | 1431 | Bulgaria |
| Sveta Petka Eye Hospital | Varna | 9000 | Bulgaria |
| Ocni klinika Oftex | Pardubice | 530 02 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Všeobecná fakultnà nemocnice v Praze | Prague | 128 08 | Czechia |
| Axon Clinical, s.r.o. | Prague | 150 00 | Czechia |
| Aalborg Universitetshospital - Øjenafdelingen | Aalborg | 9000 | Denmark |
| Aarhus Universitetshospital | Aarhus N | 8200 | Denmark |
| Rigshospitalet Glostrup - Øjensygdomme | Glostrup Municipality | 2600 | Denmark |
| Odense Universitetshospital, Dept of Ophtalmology | Odense C | 5000 | Denmark |
| Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme | Roskilde | 4000 | Denmark |
| NUVISAN GmbH Neu-Ulm | Neu-Ulm | Bavaria | 89231 | Germany |
| Riga East University Hospital, Bikernieki, Ophthalmology Clinic | Riga | LV1006 | Latvia |
| Academic Medical Center Dept Ophthalmology | Amsterdam | 1081HV | Netherlands |
| Universitair Medisch Centrum St. Radboud | Nijmegen | 6525 GA | Netherlands |
| ETZ Elisabeth Ziekenhuis | Tilburg | 5022GC | Netherlands |
| Biokinetica S.A | Józefów | 05-410 | Poland |
| Klinika Okulistyczna "Jasne Blonia" Sp. z o.o | Lodz | 91-134 | Poland |
| Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o. | Rzeszów | 35-017 | Poland |
| Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski | Tarnowskie Góry | 42-600 | Poland |
| NZOZ Centrum Badan Klinicznych | Wroclaw | 51-162 | Poland |
| AIBILI | Coimbra | 3000-548 | Portugal |
| CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia | Coimbra | 3004-561 | Portugal |
| Centro Hospitalar Universitario do Porto | Porto | 4099-001 | Portugal |
| Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos | Porto | 4200-319 | Portugal |
| Clinical Emergency County Hospital | Cluj-Napoca | 400347 | Romania |
| Fakultna Nemocnica s poliklinikou F.D.Roosevelta | Banská Bystrica | 97517 | Slovakia |
| Nemocnica Poprad, a.s. | Poprad | 058 45 | Slovakia |
| Hospital General de Catalunya | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| Hospital Universitario del Henares | Coslada | Madrid | 28822 | Spain |
| Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Virgen de la Macarena | Seville | 41071 | Spain |
| Universitätsspital Basel | Basel | Canton of Basel-City | 4056 | Switzerland |
| Inselspital Universitätsspital Bern | Bern | 3010 | Switzerland |
| University Eye Hospital Jules Gonin | Lausanne | 1004 | Switzerland |
| Stadtspital Triemli | Zurich | 8063 | Switzerland |
| Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research Group | Gloucester | Gloucestershire | GL1 3NN | United Kingdom |
| Sunderland Eye Infirmary | Sunderland | Tyne and Wear | SR29HP | United Kingdom |
| Bristol Eye Hospital | Bristol | BS12LX | United Kingdom |
| Moorfields Eye Hospital | London | EC1V2PD | United Kingdom |
| King's College Hospital NHS Foundation Trust | King's College Hospital - Neurology Department | London | SE5 9RS | United Kingdom |
Participants received matching placebo GITS tablets.
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| COMPLETED | All participants who completed the week 48 treatment |
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| NOT COMPLETED |
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The full analysis set (FAS) included 109 participants (all randomized participants)
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| ID | Title | Description |
|---|---|---|
| BG000 | Runcacigat (BAY1101042) | Participants received runcaciguat gastrointestinal therapeutic system (GITS) tablets and were treated following an intra-individual dose-titration design with three titration steps. |
| BG001 | Placebo | Participants received matching placebo GITS tablets. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | Posted | Number | 95% Confidence Interval | percentage of participants | At 48 weeks of treatment |
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| Secondary | 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:
| per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | Posted | Number | percentage of participants | At 48 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | Posted | Number | 95% Confidence Interval | percentage of participants | At 24 weeks of treatment |
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| Secondary | 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. | per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | Posted | Number | 95% Confidence Interval | percentage of participants | At 48 weeks of treatment |
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| Secondary | Number of Participants With Treatment Emergent Adverse Event (TEAE) | Safety analysis set (SAF): All participants of the respective study part who took at least one dose of study intervention. | Posted | Count of Participants | Participants | No | From first dosing up to 28 days after last dose of study intervention |
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| Other Pre-specified | Percentage of Participants With < 3 Steps Deterioration 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. | per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | Posted | Number | 95% Confidence Interval | percentage of participants | At 48 weeks of treatment |
|
|
After the first study intervention up to 28 days after the end of study intervention, with an average up to 53 weeks. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with an average of/ up to 54 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Runcaciguat (BAY1101042) | Participants received runcaciguat gastrointestinal therapeutic system (GITS) tablets and were treated following an intra-individual dose-titration design with three titration steps. | 2 | 56 | 9 | 56 | 50 | 56 |
| EG001 | Placebo | Participants received matching placebo GITS tablets. | 0 | 53 | 3 | 53 | 32 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA (27.0) | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Abdominal sepsis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Diabetic foot infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (27.0) | Systematic Assessment |
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| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
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| Dry gangrene | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
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| Peripheral artery thrombosis | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
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| Erythropenia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
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| Diabetic retinal oedema | Eye disorders | MedDRA (27.0) | Systematic Assessment |
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| Diabetic retinopathy | Eye disorders | MedDRA (27.0) | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA (27.0) | Systematic Assessment |
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| Retinal exudates | Eye disorders | MedDRA (27.0) | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA (27.0) | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA (27.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (27.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (27.0) | Systematic Assessment |
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| Glomerular filtration rate decreased | Investigations | MedDRA (27.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2024 | Apr 7, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000722786 | BAY 1101042 |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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