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

Sponsor

Bayer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04722991

Collaborator

(none)

Enrollment

104

Locations

Arms

35.7

Anticipated Duration (Months)

0.9

Patients Per Site

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 Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	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

Arm	Intervention/Treatment
Experimental: Runcaciguat (BAY1101042)	Drug: Runcaciguat (BAY1101042) Oral dose of runcaciguat
Placebo Comparator: Placebo	Other: Placebo Oral dose of matching placebo

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	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.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT04722991

Other Study ID Numbers:

20739
2020-002333-15

First Posted:

Jan 25, 2021

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bayer

Non-proliferative Diabetic Retinopathy

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Study Results

No Results Posted as of Jul 19, 2022