NEON-NPDR: Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

Sponsor
Bayer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04722991
Collaborator
(none)
98
Enrollment
75
Locations
2
Arms
35.7
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Runcaciguat (BAY1101042)
  • Other: Placebo
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-masked study
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 17, 2021
Anticipated Primary Completion Date :
Aug 16, 2023
Anticipated Study Completion Date :
Mar 9, 2024

Arms and Interventions

ArmIntervention/Treatment
Experimental: Runcaciguat (BAY1101042)

Drug: Runcaciguat (BAY1101042)
Oral dose of runcaciguat

Placebo Comparator: Placebo

Other: Placebo
Oral dose of matching placebo

Outcome Measures

Primary Outcome Measures

  1. DRSS improvement ≥2 steps at 24 weeks of treatment in the study eye [At 24 weeks of treatment]

    DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.

Secondary Outcome Measures

  1. Frequency of treatment emergent adverse events [From first dosing up to 28 days after last dose of study intervention.]

    As reported by Investigators

  2. Vision threatening complications at 48 weeks of treatment in the study eye [At 48 weeks]

  3. DRSS improvement ≥2 steps at 48 weeks of treatment in the study eye [At 48 weeks]

    DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Fakultni Nemocnice BrnoBrnoCzechia625 00
2Fakultni Nemocnice BrnoBrnoCzechia625 00
3Krajska Nemocnice LiberecLiberecCzechia46063
4Fakultni nemocnice OstravaOstravaCzechia708 52
5Fakultni nemocnice OstravaOstravaCzechia708 52
6Fakultni nemocnice Kralovske VinohradyPraha 10Czechia100 34
7Vseobecna fakultni nemocnice v PrazePraha 2Czechia12808
8AXON Clinical s.r.o.Praha 5Czechia150 00
9Aalborg UniversitetshospitalAalborgDenmark9000
10Aarhus Universitetshospital, SkejbyAarhus NDenmark8200
11Glostrup HospitalGlostrupDenmark2600
12Odense UniversitetshospitalOdense CDenmark5000
13Sjællands Universitetshospital RoskildeRoskildeDenmark4000
14NUVISAN GmbHNeu-UlmBayernGermany89231
15NUVISAN GmbHNeu-UlmBayernGermany89231
16Makula-Netzhaut-Zentrum OberkasselDüsseldorf OberkasselNordrhein-WestfalenGermany40549
17Makula-Netzhaut-Zentrum OberkasselDüsseldorf OberkasselNordrhein-WestfalenGermany40549
18Augenzentrum am St. Franziskus-HospitalMünsterNordrhein-WestfalenGermany48145
19Augenzentrum am St. Franziskus-HospitalMünsterNordrhein-WestfalenGermany48145
20SocraTec R&D GmbHErfurtThüringenGermany99084
21SocraTec R&D GmbHErfurtThüringenGermany99084
22MH Egeszsegugyi KozpontBudapestHungary1062
23MH Egeszsegugyi KozpontBudapestHungary1062
24Peterfy Kh-RI es Manninger Jeno Orszagos Traum. IntezetBudapestHungary1076
25Peterfy Kh-RI es Manninger Jeno Orszagos Traum. IntezetBudapestHungary1076
26EKBC, Uj Szent Janos Korhaz es SzakrendeloBudapestHungary1125
27EKBC, Uj Szent Janos Korhaz es SzakrendeloBudapestHungary1125
28Budapest Retina AssociatesBudapestHungary1133
29Debreceni Egyetem Klinikai KozpontDebrecenHungary4032
30Debreceni Egyetem Klinikai KozpontDebrecenHungary4032
31Ganglion Medical CenterPecsHungary7621
32IRCCS Fondazione G.B. Bietti Studio e Ricerca in OtalmologiaRomaLazioItaly00198
33IRCCS Fondazione G.B. Bietti Studio e Ricerca in OtalmologiaRomaLazioItaly00198
34Ospedale San Raffaele s.r.l.MilanoLombardiaItaly20132
35Ospedale San Raffaele s.r.l.MilanoLombardiaItaly20132
36ASST Fatebenefratelli SaccoMilanoLombardiaItaly20157
37ASST Fatebenefratelli SaccoMilanoLombardiaItaly20157
38A.O.U. di CagliariCagliariSardegnaItaly09124
39A.O.U. di CagliariCagliariSardegnaItaly09124
40A.O.U. di PadovaPadovaVenetoItaly35128
41A.O.U. di PadovaPadovaVenetoItaly35128
42VUmcAmsterdamNetherlands1081 HV
43Academic Medical Center Dept OphthalmologyAmsterdamNetherlands1100 DD
44Universitair Medisch Centrum GroningenGroningenNetherlands9713 GZ
45Leids Universitair Medisch CentrumLeidenNetherlands2333 ZA
46Universitair Medisch Centrum St. RadboudNijmegenNetherlands
47OogziekenhuisRotterdamNetherlands3011 BH
48ETZ Elisabeth ZiekenhuisTilburgNetherlands5022 GC
49Biokinetica S.AJozefowPoland05-410
50Centrum Medyczne Dietla 19 Sp. z o.o.KrakowPoland31-070
51Klinika Okulistyczna "Jasne Blonia" Sp. z o.oLodzPoland91-134
52Indywidualna Praktyka Lekarska Robert Adam RejdakLublinPoland20-562
53Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o.RzeszowPoland35-017
54Ind. Spec. Prakt. Lek. Dr W. JedrzejewskiTarnowskie GoryPoland42-600
55NZOZ Centrum Badan KlinicznychWroclawPoland51-162
56Hospital de Vila Franca de XiraVila Franca de XiraLisboaPortugal2600-178
57Hospital de Vila Franca de XiraVila Franca de XiraLisboaPortugal2600-178
58CHUC - Hospitais da Universidade de CoimbraCoimbraPortugal3000-075
59AIBILICoimbraPortugal3000-548
60CHUP - Hospital Santo AntonioPortoPortugal4099-001
61CHUSJ - Hospital Sao JoaoPortoPortugal4200-319
62Hospital General de CatalunyaSant Cugat del VallésBarcelonaSpain08195
63Hospital Universitario de HenaresCosladaMadridSpain28822
64Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelonaSpain08035
65Instituto de Salud Carlos IIIMadridSpain28029
66Hospital Universitario Virgen de la MacarenaSevillaSpain41071
67Universitätsspital BaselBaselBasel-StadtSwitzerland4056
68Inselspital Universitätsspital BernBernSwitzerland3010
69University Eye Hospital Jules GoninLausanneSwitzerland1004
70Stadtspital TriemliZürichSwitzerland8063
71Gloucester Royal InfirmaryGloucesterGloucestershireUnited KingdomGL1 3NN
72Sunderland Eye InfirmarySunderlandTyne And WearUnited KingdomSR2 9HP
73Bristol Eye HospitalBristolUnited KingdomBS1 2LX
74Moorfields Eye HospitalLondonUnited KingdomEC1V 2PD
75King's College Hospital - NHS Foundation TrustLondonUnited KingdomSE5 9RS

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT04722991
Other Study ID Numbers:
  • 20739
  • 2020-002333-15
First Posted:
Jan 25, 2021
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bayer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2022