Trial Condition(s):

Diabetic Retinopathy

Non-proliferative diabetic retinopathy treated with runcaciguat (NEON-NPDR)

Bayer Identifier:

20739

ClinicalTrials.gov Identifier:

NCT04722991

EudraCT Number:

2020-002333-15

Recruiting

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
98
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Runcaciguat (BAY1101042)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

NUVISAN GmbH Neu-Ulm

Neu-Ulm, Germany, 89231

Status
Completed
 
Locations

Odense Universitetshospital, Dept of Ophtalmology

Odense C, Denmark, 5000

Status
Recruiting
 
Locations

Sjællands Universitetshospital Roskilde

Roskilde, Denmark, 4000

Status
Recruiting
 
Locations

Glostrup Hospital

Glostrup, Denmark, 2600

Status
Not yet recruiting
 
Locations

Aalborg Universitetshospital, Ophtalmology dept.

Aalborg, Denmark, 9000

Status
Recruiting
 
Locations

Aarhus Universitetshospital, Skejby

Aarhus N, Denmark, 8200

Status
Recruiting
 
Locations

Biokinetica S.A

Jozefow, Poland, 05-410

Status
Recruiting
 
Locations

NZOZ Centrum Badan Klinicznych

Wroclaw, Poland, 51-162

Status
Recruiting
 
Locations

CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia

Coimbra, Portugal, 3004-561

Status
Not yet recruiting
 
Locations

Centro Hospitalar Universitario do Porto

Porto, Portugal, 4099-001

Status
Recruiting
 
Locations

Gloucester Royal Infirmary

Gloucester, United Kingdom, GL1 3NN

Status
Not yet recruiting
 
Locations

Sunderland Eye Infirmary

Sunderland, United Kingdom, SR2 9HP

Status
Recruiting
 
Locations

Moorfields Eye Hospital

London, United Kingdom, EC1V 2PD

Status
Recruiting
 
Locations

Bristol Eye Hospital

Bristol, United Kingdom, BS1 2LX

Status
Not yet recruiting
 
Locations

Vseobecna fakultni nemocnice v Praze

Praha 2, Czech Republic, 128 08

Status
Recruiting
 
Locations

Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czech Republic, 100 34

Status
Recruiting
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4056

Status
Not yet recruiting
 
Locations

University Eye Hospital Jules Gonin

Lausanne, Switzerland, 1004

Status
Not yet recruiting
 
Locations

Stadtspital Triemli

Zürich, Switzerland, 8063

Status
Not yet recruiting
 
Locations

Inselspital Universitätsspital Bern

Bern, Switzerland, 3010

Status
Not yet recruiting
 
Locations

King's College Hospital - NHS Foundation Trust

London, United Kingdom, SE5 9RS

Status
Recruiting
 
Locations

Krajska Nemocnice Liberec a.s.

Liberec, Czech Republic, 460 63

Status
Not yet recruiting
 
Locations

AXON Clinical s.r.o.

Praha 5, Czech Republic, 150 00

Status
Not yet recruiting
 
Locations

Academic Medical Center Dept Ophthalmology

Amsterdam, Netherlands, 1100 DD

Status
Recruiting
 
Locations

Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands

Status
Recruiting
 
Locations

ETZ Elisabeth Ziekenhuis

Tilburg, Netherlands, 5022 GC

Status
Recruiting
 
Locations

Hospital Universitario Virgen de la Macarena

Sevilla, Spain, 41071

Status
Recruiting
 
Locations

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Recruiting
 
Locations

Hospital General de Catalunya

Sant Cugat del Vallés, Spain, 08195

Status
Recruiting
 
Locations

Hospital Universitario de Henares

Coslada, Spain, 28822

Status
Recruiting
 
Locations

AIBILI

Coimbra, Portugal, 3000-548

Status
Recruiting
 
Locations

CHUSJ - Hospital Sao Joao

Porto, Portugal, 4200-319

Status
Recruiting
 
Locations

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9713 GZ

Status
Not yet recruiting
 
Locations

Ophthal sp. z o.o.

Lublin, Poland, 20-567

Status
Not yet recruiting
 
Locations

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

Rzeszow, Poland, 35-017

Status
Not yet recruiting
 
Locations

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

Lodz, Poland, 91-134

Status
Recruiting
 
Locations

Leids Universitair Medisch Centrum

LEIDEN, Netherlands, 2333 ZA

Status
Not yet recruiting
 
Locations

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

Tarnowskie Gory, Poland, 42-600

Status
Recruiting
 
Locations

CHEDV - Hospital Sao Sebastiao

Santa Maria da Feira, Portugal, 4520-211

Status
Not yet recruiting
 
Locations

Hospital CUF Tejo

Lisboa, Portugal, 1350-352

Status
Not yet recruiting
 
Locations

Nemocnica Poprad, a.s.

Poprad, Slovakia, 058 45

Status
Not yet recruiting
 
Locations

Fakultna Nemocnica s poliklinikou F.D.Roosevelta

Banska Bystrica, Slovakia, 97517

Status
Recruiting
 
Locations

Gulf Coast Institute / Valley Retina Institute

McAllen, United States, 78503

Status
Recruiting
 
Locations

Florida Retina Consultants

Lakeland, United States, 33805

Status
Recruiting
 
Locations

Austin Research Center for Retina

Austin, United States, 78705

Status
Recruiting
 
Locations

Retina Consultants of Houston

The Woodlands, United States, 77384

Status
Recruiting
 
Locations

Riga East Clinical University Hospital "Gailezers"

Riga, Latvia, LV-1006

Status
Not yet recruiting
 
Locations

S.C. ONIOPTIC MEDICAL PD SRL

Craiova, Romania

Status
Not yet recruiting
 
Locations

Clinical Emergency County Hospital

Cluj-Napoca, Romania, 400006

Status
Not yet recruiting
 
Locations

Ocni klinika Oftex

Pardubice, Czech Republic, 530 02

Status
Not yet recruiting
 
Locations

DCC Aleksandrovska

Sofia, Bulgaria, 1431

Status
Not yet recruiting
 
Locations

UMHAT Sveti Georgi

Plovdiv, Bulgaria, 4002

Status
Recruiting
 
Locations

Eye center Sveti Luka

Plovdiv, Bulgaria, 4001

Status
Recruiting
 
Locations

Sveta Petka Eye Hospital

Varna, Bulgaria, 9002

Status
Recruiting
 
Locations

SEHAT Pentagram

Sofia, Bulgaria, 1309

Status
Recruiting
 
Locations

Cumberland Valley Retina Consultants, PC

Hagerstown, United States, 21740

Status
Recruiting
 
Locations

Retinal Consultants of Texas - San Antonio

San Antonio, United States, 78240

Status
Recruiting
 
Locations

Austin Retina Associates

Austin, United States, 78705

Status
Recruiting
 
Locations

Palmetto Retina Center, LLC - Florence

Florence, United States, 29501

Status
Not yet recruiting
 
Locations

Retinal Consultants Medical Group, Inc

Sacramento, United States, 95825

Status
Not yet recruiting
 
Locations

Retina Consultants of Southern California

Redlands, United States, 92374

Status
Not yet recruiting
 
Locations

Eye Associates of Pinellas

Pinellas Park, United States, 33782

Status
Not yet recruiting
 
Locations

Mid Atlantic Retina Specialists

Hagerstown, United States, 21740

Status
Recruiting
 
Locations

Retinal Consultants of Texas - San Antonio

Bellaire, United States, 77401

Status
Not yet recruiting
 

Trial Design