NEON-NPDR: Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
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 Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/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
- 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
- Frequency of treatment emergent adverse events [From first dosing up to 28 days after last dose of study intervention.]
As reported by Investigators
- Vision threatening complications at 48 weeks of treatment in the study eye [At 48 weeks]
- 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
Main Inclusion Criteria:
-
Moderately severe to severe NPDR in the study eye: Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53
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Diabetes type 1 or 2
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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:
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Presence or history of macular edema involving the center of the macula
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Any kind of neovascular growth in the study eye, including anterior segment neovascularization
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Arterial hypotension with systolic blood pressure < 100 or diastolic blood pressure < 60mmHg
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Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 3 x Upper limit of normal (ULN) or bilirubin ≥ 1.5 ULN at screening, known ascites
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Estimated glomerular filtration rate (eGFR CKD-EPI) below 30 ml/min/1.73 m^2 at screening
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Any prior systemic anti-Vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye
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Any prior intraocular steroid injection in the study eye
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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
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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
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Florida Retina Consultants | Lakeland | Florida | United States | 33805 |
2 | Cumberland Valley Retina Consultants, PC | Hagerstown | Maryland | United States | 21740 |
3 | Austin Research Center for Retina | Austin | Texas | United States | 78705 |
4 | Retina Consultants of Houston | Houston | Texas | United States | 77030 |
5 | Gulf Coast Institute / Valley Retina Institute | McAllen | Texas | United States | 78503 |
6 | Eye center Sveti Luka | Plovdiv | Bulgaria | 4001 | |
7 | UMHAT Sveti Georgi | Plovdiv | Bulgaria | 4002 | |
8 | SEHAT Pentagram | Sofia | Bulgaria | 1309 | |
9 | DCC Aleksandrovska | Sofia | Bulgaria | 1606 | |
10 | Sveta Petka Eye Hospital | Varna | Bulgaria | 9002 | |
11 | Clinique d'ophtalmologie des Laurentides | Boisbrand | Quebec | Canada | J7H 0E8 |
12 | Fakultni nemocnice Brno | Brno | Czechia | 625 00 | |
13 | Fakultni Nemocnice Brno | Brno | Czechia | 625 00 | |
14 | Krajska Nemocnice Liberec a.s. | Liberec | Czechia | 460 63 | |
15 | Krajska Nemocnice Liberec | Liberec | Czechia | 46063 | |
16 | Fakultni nemocnice Ostrava | Ostrava | Czechia | 708 52 | |
17 | Fakultni nemocnice Ostrava | Ostrava | Czechia | 708 52 | |
18 | Ocni klinika Oftex | Pardubice | Czechia | 530 02 | |
19 | Fakultni nemocnice Kralovske Vinohrady | Praha 10 | Czechia | 100 34 | |
20 | Vseobecna fakultni nemocnice v Praze | Praha 2 | Czechia | 128 08 | |
21 | Vseobecna fakultni nemocnice v Praze | Praha 2 | Czechia | 12808 | |
22 | AXON Clinical s.r.o. | Praha 5 | Czechia | 150 00 | |
23 | Aalborg Universitetshospital, Ophtalmology dept. | Aalborg | Denmark | 9000 | |
24 | Aalborg Universitetshospital | Aalborg | Denmark | 9000 | |
25 | Aarhus Universitetshospital, Skejby | Aarhus N | Denmark | 8200 | |
26 | Glostrup Hospital | Glostrup | Denmark | 2600 | |
27 | Odense Universitetshospital, Dept of Ophtalmology | Odense C | Denmark | 5000 | |
28 | Odense Universitetshospital | Odense C | Denmark | 5000 | |
29 | Sjællands Universitetshospital Roskilde | Roskilde | Denmark | 4000 | |
30 | NUVISAN GmbH | Neu-Ulm | Bayern | Germany | 89231 |
31 | NUVISAN GmbH | Neu-Ulm | Bayern | Germany | 89231 |
32 | Makula-Netzhaut-Zentrum Oberkassel | Düsseldorf Oberkassel | Nordrhein-Westfalen | Germany | 40549 |
33 | Internationale Innovative Ophthalmochirurgie GbR | Düsseldorf | Nordrhein-Westfalen | Germany | 40549 |
34 | Augenzentrum am St. Franziskus-Hospital | Münster | Nordrhein-Westfalen | Germany | 48145 |
35 | Augenzentrum am St. Franziskus-Hospital | Münster | Nordrhein-Westfalen | Germany | 48145 |
36 | SocraTec R&D GmbH | Erfurt | Thüringen | Germany | 99084 |
37 | SocraTec R&D GmbH | Erfurt | Thüringen | Germany | 99084 |
38 | MH Egeszsegugyi Kozpont | Budapest | Hungary | 1062 | |
39 | MH Egeszsegugyi Kozpont | Budapest | Hungary | 1062 | |
40 | Peterfy Kh-RI es Manninger Jeno Orszagos Traum. Intezet | Budapest | Hungary | 1076 | |
41 | Peterfy Kh-RI es Manninger Jeno Orszagos Traum. Intezet | Budapest | Hungary | 1076 | |
42 | EKBC, Uj Szent Janos Korhaz es Szakrendelo | Budapest | Hungary | 1125 | |
43 | EKBC, Uj Szent Janos Korhaz es Szakrendelo | Budapest | Hungary | 1125 | |
44 | Budapest Retina Associates | Budapest | Hungary | 1133 | |
45 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | 4032 | |
46 | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hungary | 4032 | |
47 | Ganglion Medical Center | Pecs | Hungary | 7621 | |
48 | IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia | Roma | Lazio | Italy | 00198 |
49 | IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia | Roma | Lazio | Italy | 00198 |
50 | Ospedale San Raffaele s.r.l. | Milano | Lombardia | Italy | 20132 |
51 | Ospedale San Raffaele s.r.l. | Milano | Lombardia | Italy | 20132 |
52 | ASST Fatebenefratelli Sacco | Milano | Lombardia | Italy | 20157 |
53 | ASST Fatebenefratelli Sacco | Milano | Lombardia | Italy | 20157 |
54 | A.O.U. di Cagliari | Cagliari | Sardegna | Italy | 09124 |
55 | A.O.U. di Cagliari | Cagliari | Sardegna | Italy | 09124 |
56 | A.O.U. di Padova | Padova | Veneto | Italy | 35128 |
57 | A.O.U. di Padova | Padova | Veneto | Italy | 35128 |
58 | Riga East Clinical University Hospital "Gailezers" | Riga | Latvia | LV-1006 | |
59 | VUmc | Amsterdam | Netherlands | 1081 HV | |
60 | Academic Medical Center Dept Ophthalmology | Amsterdam | Netherlands | 1100 DD | |
61 | Universitair Medisch Centrum Groningen | Groningen | Netherlands | 9713 GZ | |
62 | Leids Universitair Medisch Centrum | Leiden | Netherlands | 2333 ZA | |
63 | Universitair Medisch Centrum St. Radboud | Nijmegen | Netherlands | ||
64 | Universitair Medisch Centrum St. Radboud | Nijmegen | Netherlands | ||
65 | Oogziekenhuis | Rotterdam | Netherlands | 3011 BH | |
66 | ETZ Elisabeth Ziekenhuis | Tilburg | Netherlands | 5022 GC | |
67 | Biokinetica S.A | Jozefow | Poland | 05-410 | |
68 | Centrum Medyczne Dietla 19 Sp. z o.o. | Krakow | Poland | 31-070 | |
69 | Klinika Okulistyczna "Jasne Blonia" Sp. z o.o | Lodz | Poland | 91-134 | |
70 | Indywidualna Praktyka Lekarska Robert Adam Rejdak | Lublin | Poland | 20-562 | |
71 | Ophthal sp. z o.o. | Lublin | Poland | 20-567 | |
72 | Osrodek Chirurgii Oka prof. Zagorskiego Sp. z o.o. | Rzeszow | Poland | 35-017 | |
73 | Ind. Spec. Prakt. Lek. Dr W. Jedrzejewski | Tarnowskie Gory | Poland | 42-600 | |
74 | NZOZ Centrum Badan Klinicznych | Wroclaw | Poland | 51-162 | |
75 | CHEDV - Hospital Sao Sebastiao | Santa Maria da Feira | Aveiro | Portugal | 4520-211 |
76 | Hospital de Vila Franca de Xira | Vila Franca de Xira | Lisboa | Portugal | 2600-178 |
77 | Hospital de Vila Franca de Xira | Vila Franca de Xira | Lisboa | Portugal | 2600-178 |
78 | CHUC - Hospitais da Universidade de Coimbra | Coimbra | Portugal | 3000-075 | |
79 | AIBILI | Coimbra | Portugal | 3000-548 | |
80 | AIBILI | Coimbra | Portugal | 3000-548 | |
81 | CHUC - Hospitais da U. Coimbra - Servico de Oftalmologia | Coimbra | Portugal | 3004-561 | |
82 | Hospital CUF Tejo | Lisboa | Portugal | 1350-352 | |
83 | Centro Hospitalar Universitario do Porto | Porto | Portugal | 4099-001 | |
84 | CHUP - Hospital Santo Antonio | Porto | Portugal | 4099-001 | |
85 | CHUSJ - Hospital Sao Joao | Porto | Portugal | 4200-319 | |
86 | S.C. Onioptic Medical Pd Srl | Craiova | Dolj | Romania | |
87 | Clinical Emergency County Hospital | Cluj-Napoca | Romania | 400006 | |
88 | Fakultna Nemocnica s poliklinikou F.D.Roosevelta | Banska Bystrica | Slovakia | 97517 | |
89 | Nemocnica Poprad, a.s. | Poprad | Slovakia | 058 45 | |
90 | Fakultna nemocnica s poliklinikou Zilina | Zilina | Slovakia | 012 07 | |
91 | Hospital General de Catalunya | Sant Cugat del Vallés | Barcelona | Spain | 08195 |
92 | Hospital Universitario de Henares | Coslada | Madrid | Spain | 28822 |
93 | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona | Spain | 08035 | |
94 | Instituto de Salud Carlos III | Madrid | Spain | 28029 | |
95 | Hospital Universitario Virgen de la Macarena | Sevilla | Spain | 41071 | |
96 | Universitätsspital Basel | Basel | Basel-Stadt | Switzerland | 4056 |
97 | Inselspital Universitätsspital Bern | Bern | Switzerland | 3010 | |
98 | University Eye Hospital Jules Gonin | Lausanne | Switzerland | 1004 | |
99 | Stadtspital Triemli | Zürich | Switzerland | 8063 | |
100 | Gloucester Royal Infirmary | Gloucester | Gloucestershire | United Kingdom | GL1 3NN |
101 | Sunderland Eye Infirmary | Sunderland | Tyne And Wear | United Kingdom | SR2 9HP |
102 | Bristol Eye Hospital | Bristol | United Kingdom | BS1 2LX | |
103 | Moorfields Eye Hospital | London | United Kingdom | EC1V 2PD | |
104 | King's College Hospital - NHS Foundation Trust | London | United Kingdom | SE5 9RS |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20739
- 2020-002333-15