Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

NCT04722991 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 207392020-002333-15
• Study Type: interventional
• Target: 109
• Locations: 14 countries
• Sites: 55

Brief Summary

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.

Conditions

Diabetic Retinopathy

Keywords

Non-proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye

  At 48 weeks

• Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye

  At 24 weeks of treatment

• Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale

  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

Other Outcomes (1)

• Percentage of Participants With < 3 Steps Deterioration in DRSS at 48 Weeks of Treatment on the for Persons Scale

  At 48 weeks of treatment

Study Arms (2)

Runcaciguat (BAY1101042)

EXPERIMENTAL

Drug: Runcaciguat (BAY1101042)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Runcaciguat (BAY1101042) DRUG

Oral dose of runcaciguat

Runcaciguat (BAY1101042)

Placebo OTHER

Oral dose of matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (55)

Retinal Consultants Medical Group, Inc

Modesto, California, 95256, United States

Location

Florida Retina Consultants

Lakeland, Florida, 33805, United States

Location

Eye Associates of Pinellas

Pinellas Park, Florida, 33782, United States

Location

Cumberland Valley Retina Consultants | Hagerstown, MD

Hagerstown, Maryland, 21740, United States

Location

Mid Atlantic Retina Specialists - Hagerstown

Hagerstown, Maryland, 21740, United States

Location

Austin Research Center for Retina

Austin, Texas, 78705-1023, United States

Location

Austin Retina Associates - Central

Austin, Texas, 78705, United States

Location

Retinal Consultants of Texas - Bellaire

Bellaire, Texas, 77401, United States

Location

Gulf Coast Eye Institute / Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Retinal Consultants of Texas - San Antonio

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas - The Woodlands

The Woodlands, Texas, 77384, United States

Location

Eye center Sveti Luka

Plovdiv, 4001, Bulgaria

Location

UMHAT Sveti Georgi

Plovdiv, 4002, Bulgaria

Location

SEHAT Pentagram

Sofia, 1309, Bulgaria

Location

Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria

Sofia, 1431, Bulgaria

Location

Sveta Petka Eye Hospital

Varna, 9000, Bulgaria

Location

Ocni klinika Oftex

Pardubice, 530 02, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

Všeobecná fakultní nemocnice v Praze

Prague, 128 08, Czechia

Location

Axon Clinical, s.r.o.

Prague, 150 00, Czechia

Location

Aalborg Universitetshospital - Øjenafdelingen

Aalborg, 9000, Denmark

Location

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

Location

Rigshospitalet Glostrup - Øjensygdomme

Glostrup Municipality, 2600, Denmark

Location

Odense Universitetshospital, Dept of Ophtalmology

Odense C, 5000, Denmark

Location

Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme

Roskilde, 4000, Denmark

Location

NUVISAN GmbH Neu-Ulm

Neu-Ulm, Bavaria, 89231, Germany

Location

Riga East University Hospital, Bikernieki, Ophthalmology Clinic

Riga, LV1006, Latvia

Location

Academic Medical Center Dept Ophthalmology

Amsterdam, 1081HV, Netherlands

Location

Universitair Medisch Centrum St. Radboud

Nijmegen, 6525 GA, Netherlands

Location

ETZ Elisabeth Ziekenhuis

Tilburg, 5022GC, Netherlands

Location

Biokinetica S.A

Józefów, 05-410, Poland

Location

Klinika Okulistyczna "Jasne Blonia" Sp. z o.o

Lodz, 91-134, Poland

Location

Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.

Rzeszów, 35-017, Poland

Location

Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski

Tarnowskie Góry, 42-600, Poland

Location

NZOZ Centrum Badan Klinicznych

Wroclaw, 51-162, Poland

Location

AIBILI

Coimbra, 3000-548, Portugal

Location

CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia

Coimbra, 3004-561, Portugal

Location

Centro Hospitalar Universitario do Porto

Porto, 4099-001, Portugal

Location

Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos

Porto, 4200-319, Portugal

Location

Clinical Emergency County Hospital

Cluj-Napoca, 400347, Romania

Location

Fakultna Nemocnica s poliklinikou F.D.Roosevelta

Banská Bystrica, 97517, Slovakia

Location

Nemocnica Poprad, a.s.

Poprad, 058 45, Slovakia

Location

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Hospital Universitario del Henares

Coslada, Madrid, 28822, Spain

Location

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, 41071, Spain

Location

Universitätsspital Basel

Basel, Canton of Basel-City, 4056, Switzerland

Location

Inselspital Universitätsspital Bern

Bern, 3010, Switzerland

Location

University Eye Hospital Jules Gonin

Lausanne, 1004, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research Group

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

Location

Sunderland Eye Infirmary

Sunderland, Tyne and Wear, SR29HP, United Kingdom

Location

Bristol Eye Hospital

Bristol, BS12LX, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V2PD, United Kingdom

Location

King's College Hospital NHS Foundation Trust | King's College Hospital - Neurology Department

London, SE5 9RS, United Kingdom

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

BAY 1101042

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-masked study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 25, 2021
• Study Start: March 17, 2021
• Primary Completion: March 18, 2024
• Study Completion: April 22, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4); US (11); CZ (4); BU (5); ES (4); PL (5); RO (1); LA (1); DE (1); NL (3); PT (4); GB (5); DK (5); SL (2)