Diabetic RetinopathyPhase 2NEON-NPDRNCT04722991
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
A Phase 2 study testing Runcaciguat (BAY1101042) in people with Diabetic Retinopathy, run by Bayer at 55 sites in 14 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Runcaciguat (BAY1101042)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 55 sitesin 14 countries
- Study dates
- 17 Mar 2021to 22 Apr 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
55 sites in 14 countries.
55 sites in 14 countries
United States11 sites
Austin Research Center for Retina
Austin, Texas, 78705-1023
Austin Retina Associates - Central
Austin, Texas, 78705
Retinal Consultants of Texas - Bellaire
Bellaire, Texas, 77401
Cumberland Valley Retina Consultants | Hagerstown, MD
Hagerstown, Maryland, 21740
Mid Atlantic Retina Specialists - Hagerstown
Hagerstown, Maryland, 21740
Florida Retina Consultants
Lakeland, Florida, 33805
Gulf Coast Eye Institute / Valley Retina Institute
McAllen, Texas, 78503
Retinal Consultants Medical Group, Inc
Modesto, California, 95256
Eye Associates of Pinellas
Pinellas Park, Florida, 33782
Retinal Consultants of Texas - San Antonio
San Antonio, Texas, 78240
Retina Consultants of Texas - The Woodlands
The Woodlands, Texas, 77384
Bulgaria5 sites
Eye center Sveti Luka
Plovdiv, 4001
UMHAT Sveti Georgi
Plovdiv, 4002
SEHAT Pentagram
Sofia, 1309
Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria
Sofia, 1431
Sveta Petka Eye Hospital
Varna, 9000
Denmark5 sites
Aalborg Universitetshospital - Øjenafdelingen
Aalborg, 9000
Aarhus Universitetshospital
Aarhus N, 8200
Rigshospitalet Glostrup - Øjensygdomme
Glostrup Municipality, 2600
Odense Universitetshospital, Dept of Ophtalmology
Odense C, 5000
Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme
Roskilde, 4000
Poland5 sites
Biokinetica S.A
Józefów, 05-410
Klinika Okulistyczna "Jasne Blonia" Sp. z o.o
Lodz, 91-134
Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.
Rzeszów, 35-017
Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski
Tarnowskie Góry, 42-600
NZOZ Centrum Badan Klinicznych
Wroclaw, 51-162
United Kingdom5 sites
Bristol Eye Hospital
Bristol, BS12LX
Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire Royal Hospital - Gloucestershire Retinal Research Group
Gloucester, Gloucestershire, GL1 3NN
Moorfields Eye Hospital
London, EC1V2PD
King's College Hospital NHS Foundation Trust | King's College Hospital - Neurology Department
London, SE5 9RS
Sunderland Eye Infirmary
Sunderland, Tyne and Wear, SR29HP
Czechia4 sites
Ocni klinika Oftex
Pardubice, 530 02
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Všeobecná fakultní nemocnice v Praze
Prague, 128 08
Axon Clinical, s.r.o.
Prague, 150 00
Portugal4 sites
AIBILI
Coimbra, 3000-548
CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia
Coimbra, 3004-561
Centro Hospitalar Universitario do Porto
Porto, 4099-001
Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos
Porto, 4200-319
Spain4 sites
Ciutat Sanitaria i Universitaria de la Vall d'Hebron
Barcelona, 08035
Hospital Universitario del Henares
Coslada, Madrid, 28822
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Hospital Universitario Virgen de la Macarena
Seville, 41071
Switzerland4 sites
Universitätsspital Basel
Basel, Canton of Basel-City, 4056
Inselspital Universitätsspital Bern
Bern, 3010
University Eye Hospital Jules Gonin
Lausanne, 1004
Stadtspital Triemli
Zurich, 8063
Netherlands3 sites
Academic Medical Center Dept Ophthalmology
Amsterdam, 1081HV
Universitair Medisch Centrum St. Radboud
Nijmegen, 6525 GA
ETZ Elisabeth Ziekenhuis
Tilburg, 5022GC
Slovakia2 sites
Fakultna Nemocnica s poliklinikou F.D.Roosevelta
Banská Bystrica, 97517
Nemocnica Poprad, a.s.
Poprad, 058 45
Latvia1 site
Riga East University Hospital, Bikernieki, Ophthalmology Clinic
Riga, LV1006
About this study
Official title: 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
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
- Being tested
- Runcaciguat (BAY1101042), Placebo
- Keywords
- Non-proliferative Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Runcaciguat (BAY1101042)Drug
Oral dose of runcaciguat
PlaceboOther
Oral dose of matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Runcaciguat (BAY1101042) | Experimental | Not described Receives: Drug: Runcaciguat (BAY1101042) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 48 weeks of treatment
Secondary outcomes (4)
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:
- Proliferative diabetic retinopathy (PDR) (DRSS ≥61)
- Any ocular neo-vascularization (retinal or anterior-segment neovascularization)
- Center-involved (central Early Treatment Diabetic Retinopathy Study [ETDRS] subfield) DME
- Drop of Best corrected visual acuity (BCVA) of 10 letters or more from baseline
Measured: 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.
Measured: 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.
Measured: At 48 weeks of treatment
Number of Participants With Treatment Emergent Adverse Event (TEAE)
Measured: From first dosing up to 28 days after last dose of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start17 Mar 2021
- Primary completion18 Mar 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722991
- Sponsor's protocol ID
- 20739
- Other IDs
- 2020-002333-15
- Acronym
- NEON-NPDR
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2021
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No