CANBERRA: A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04265261
Collaborator
(none)
135
Enrollment
71
Locations
3
Arms
20.2
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study's main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Masked, 48-Week, Parallel-Group, Placebo-Controlled, Proof-of-Concept Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
Actual Study Start Date :
Jun 5, 2020
Anticipated Primary Completion Date :
Feb 9, 2022
Anticipated Study Completion Date :
Feb 9, 2022

Arms and Interventions

ArmIntervention/Treatment
Placebo Comparator: Group A

Participants will receive an oral dose of placebo matched to RG7774 once daily (QD)

Drug: Placebo
Participants will receive oral placebo matched to RG7774

Experimental: Group B

Participants will receive a low oral dose of RG7774 QD

Drug: RG7774
Participants will receive oral RG7774

Experimental: Group C

Participants will receive a high oral dose of RG7774 QD

Drug: RG7774
Participants will receive oral RG7774

Outcome Measures

Primary Outcome Measures

  1. Proportion of Participants with >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) from Baseline at Week 36 Measured in the Study Eye [Week 36]

  2. Percentage of Participants with Adverse Events (AEs) [From baseline up to 52 weeks]

Secondary Outcome Measures

  1. Percentage of Participants with Anterior Segment Neovascularization (ASNV), new Proliferative Diabetic Retinopathy (PDR), new Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention [From baseline up to 52 weeks]

  2. Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [Baseline; Week 36]

Eligibility Criteria

Criteria

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

Inclusion Criteria

  • Able and willing to provide written informed consent and to comply with the study protocol according to International Conference of Harmonization (ICH) and local regulations

  • Male and female patients of at least 18 years of age

  • Treatment naïve with moderately severe to severe NPDR defined as ETDRS DRSS 47 or 53

  • Patients are eligible with and without DME in either eye

  • BCVA score at screening of at least 70 letters in study eyes without DME and at least 75 letters in case DME is present

  • Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images.

  • Diagnosis of diabetes mellitus (DM) type 1 or type 2

  • Hemoglobin A1c (HbA1c) </= 12%.

  • A female is eligible to participate if she is not pregnant, not breastfeeding

Exclusion Criteria

Ocular criteria for study eye:
  • Prior treatment for DR or other retinal diseases with any approved or investigational therapy, including but not limited to intravitreal steroids, intravitreal anti-VEGF, light therapy, periocular pharmacological intervention, and laser (e.g. focal, grid, micropulse, or pan-retinal)

  • Uncontrolled glaucoma

  • Any concurrent intraocular condition (e.g. retinal detachment, dense cataract, epiretinal membrane with traction, or vitreomacular traction, etc.) that in the opinion of the Investigator could reduce the potential for improvement, require medical surgical intervention or may confound the visual and functional assessment and interpretation of study results

Concurrent ocular conditions in either eye:
  • Any active ocular infection

  • Any active intraocular inflammation

General Criteria:
  • Previous systemic use of anti-VEGF drugs within 6 months prior to screening

  • Complications of diabetes such as end-stage renal disease or liver disease

  • Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to screening

  • Uncontrolled blood pressure ([BP] defined as systolic > 180mmHg and/or diastolic >100 mmHg while patient at rest)

  • History of concurrent cardio-vascular disease not considered well controlled by the Investigator

  • Any major illness or major surgical procedure within one month before screening

  • History of or currently active other diseases, metabolic dysfunction, physical examination finding, malignancies not considered cured, or clinical laboratory findings giving reasonable suspicion of a condition that contraindicated the use of the investigational medicinal drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications in the opinion of the investigator

  • Known hypersensitivity to any of the excipients of the drug used, fluorescein dye or dilating eye drops

  • Use of systemic medications known to be toxic to the lens, retina or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol) used during the 6-month period prior to screening or likely need to be used

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Arizona Retina and Vitreous ConsultantsPhoenixArizonaUnited States85021
2Retina Associates TucsonTucsonArizonaUnited States85710
3Win RetinaArcadiaCaliforniaUnited States91006
4Global Research ManagementGlendaleCaliforniaUnited States91204
5Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCaliforniaUnited States90502
6Retina Consultants of Southern Colorado PCColorado SpringsColoradoUnited States80909
7Retina Group of New EnglandWaterfordConnecticutUnited States06385
8Rand EyeDeerfield BeachFloridaUnited States33064
9Florida Retina ConsultantsLakelandFloridaUnited States33805
10Florida Eye AssociatesMelbourneFloridaUnited States32901
11Medeye AssociatesMiamiFloridaUnited States33143
12Retina Specialty InstitutePensacolaFloridaUnited States32503
13Retina Vitreous Assoc of FLSaint PetersburgFloridaUnited States33711
14Southeast Retina CenterAugustaGeorgiaUnited States30909
15Marietta Eye ClinicMariettaGeorgiaUnited States30060
16Retina Associated LtdElmhurstIllinoisUnited States60126
17University Retina and Macula Associates, PCOak ForestIllinoisUnited States60452
18Cumberland Valley Retina PCHagerstownMarylandUnited States21740
19University of Michigan, Kellogg Eye CenterAnn ArborMichiganUnited States48105
20Deep Blue Retina PLLCSouthavenMississippiUnited States38671
21Discover Vision CentersIndependenceMissouriUnited States64055
22Sierra Eye AssociatesRenoNevadaUnited States89502
23Retina Center of New JerseyBloomfieldNew JerseyUnited States07003
24Eye Associates of New MexicoAlbuquerqueNew MexicoUnited States87109
25Ophthalmic Consultants of Long IslandRockville CentreNew YorkUnited States11570
26Charlotte Eye Ear Nose and Throat AssociatesCharlotteNorth CarolinaUnited States28210
27Sterling Research Group, LtdCincinnatiOhioUnited States45219
28EyeHealth NorthwestPortlandOregonUnited States97224
29Erie Retinal SurgeryEriePennsylvaniaUnited States16507
30Charleston Neuroscience InstituteLadsonSouth CarolinaUnited States29456
31Southeastern Retina Associates ChattanoogaChattanoogaTennesseeUnited States37421
32Charles Retina InstituteMemphisTennesseeUnited States38119
33Retina Res Institute of TexasAbileneTexasUnited States79606
34Retina Research CenterAustinTexasUnited States78750
35Retina Consultants of TexasBellaireTexasUnited States77401
36San Antonio Eye CenterSan AntonioTexasUnited States78215
37Retinal Consultants of HoustonThe WoodlandsTexasUnited States77384
38Strategic Clinical Research Group, LLCWillow ParkTexasUnited States76087
39Sydney Eye HospitalSydneyNew South WalesAustralia2000
40Sydney Retina Clinic and Day SurgerySydneyNew South WalesAustralia2000
41Centre For Eye Research AustraliaEast MelbourneVictoriaAustralia3002
42Specjalistyczny Ośrodek Okulistyczny OculomedicaBydgoszczPoland85-870
43Dobry Wzrok Sp Z O OGdańskPoland80-402
44Optimum Profesorskie Centrum OkulistykiGdańskPoland80-809
45Gabinet Okulistyczny Prof Edward WylegalaKatowicePoland40-594
46Centrum Medyczne UNO-MEDKrakowPoland31-070
47Centrum Diagnostyki i Mikrochirurgii Oka LENSOlsztynPoland10-424
48LensClinicRybnikPoland44-203
49Centrum Medyczne Julianow; ZeglarskaŁódźPoland91-321
50Emanuelli Research and Development Center LLCAreciboPuerto Rico00613
51Fakultna nemocnica s poliklinikou F.D. RooseveltaBanska BystricaSlovakia975 17
52Klinika Oftalmológie LFUK a UNBBratislavaSlovakia826 06
53Očná klinika UNB a SZUBratislavaSlovakia851 07
543F s.r.oKošiceSlovakia040 11
55Fakultna nemocnica TrencinTrencinSlovakia911 71
56Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenieZilinaSlovakia012 07
57Hospital Universitari de Bellvitge; Servicio de OftalmologiaHospitalet De LlobregatBarcelonaSpain8907
58Hospital General de CatalunyaSan Cugat Del VallesBarcelonaSpain08195
59Hospital Universitario Puerta de Hierro; Servicio de oftalmologiaMajadahondaMadridSpain28222
60Clinica Oftalvist ValenciaBurjassotValenciaSpain46100
61Hospital Dos de MaigBarcelonaSpain08025
62Clinica BarraquerBarcelonaSpain8021
63Hosp Clinic y Provincial de BarcelonaBarcelonaSpain8028
64Pio del Rio Hortega University HospitalValladolidSpain47012
65Miguel Servet University HospitalZaragozaSpain50009
66Royal Victoria Hospital; Outpatients DepartmentBelfastUnited KingdomBT12 6BA
67Colchester General HospitalColchester, EssexUnited KingdomCO4 5JL
68Royal Surrey County Hospital; Eye Clinic Research officeGuilfordUnited KingdomGU2 7XX
69Hull University Teaching Hospitals NHS TrustHullUnited KingdomHU3 2JZ
70Royal Liverpool University HospitalLiverpoolUnited KingdomL7 8XP
71Nottingham University Hospitals NHS TrustNottinghamUnited KingdomNG7 2UH

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT04265261
Other Study ID Numbers:
  • BP41321
  • 2019-002067-10
First Posted:
Feb 11, 2020
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021