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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
Active, not recruiting
CT.gov ID
NCT04265261
Collaborator
(none)
135
Enrollment
68
Locations
3
Arms
35.8
Anticipated Duration (Months)
2
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 Disease Intervention/Treatment Phase
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 :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/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

Site City State Country Postal Code
1 Arizona Retina and Vitreous Consultants Phoenix Arizona United States 85021
2 Retina Associates Tucson Tucson Arizona United States 85710
3 Win Retina Arcadia California United States 91006
4 Global Research Management Glendale California United States 91204
5 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
6 Retina Consultants of Southern Colorado PC Colorado Springs Colorado United States 80909
7 Retina Group of New England Waterford Connecticut United States 06385
8 Rand Eye Deerfield Beach Florida United States 33064
9 Florida Retina Consultants Lakeland Florida United States 33805
10 Florida Eye Associates Melbourne Florida United States 32901
11 Medeye Associates Miami Florida United States 33143
12 Retina Specialty Institute Pensacola Florida United States 32503
13 Retina Vitreous Assoc of FL Saint Petersburg Florida United States 33711
14 Southeast Retina Center Augusta Georgia United States 30909
15 Marietta Eye Clinic Marietta Georgia United States 30060
16 Retina Associated Ltd Elmhurst Illinois United States 60126
17 University Retina and Macula Associates, PC Lemont Illinois United States 60439
18 Cumberland Valley Retina PC Hagerstown Maryland United States 21740
19 University of Michigan, Kellogg Eye Center Ann Arbor Michigan United States 48105
20 Deep Blue Retina PLLC Southaven Mississippi United States 38671
21 Sierra Eye Associates Reno Nevada United States 89502
22 Envision Ocular, LLC Bloomfield New Jersey United States 07003
23 Eye Associates of New Mexico Albuquerque New Mexico United States 87109
24 Ophthalmic Consultants of Long Island Rockville Centre New York United States 11570
25 Charlotte Eye Ear Nose and Throat Associates Charlotte North Carolina United States 28210
26 Meridian Clinical Research Cincinnati Ohio United States 45219
27 Erie Retinal Surgery Erie Pennsylvania United States 16507
28 Charleston Neuroscience Institute Ladson South Carolina United States 29456
29 Southeastern Retina Associates Chattanooga Chattanooga Tennessee United States 37421
30 Charles Retina Institute Memphis Tennessee United States 38119
31 Retina Res Institute of Texas Abilene Texas United States 79606
32 Austin Clinical Research LLC Austin Texas United States 78750
33 Retina Consultants of Texas Bellaire Texas United States 77401
34 San Antonio Eye Center San Antonio Texas United States 78215
35 Retinal Consultants of Houston The Woodlands Texas United States 77384
36 Strategic Clinical Research Group, LLC Willow Park Texas United States 76087
37 Sydney Eye Hospital Sydney New South Wales Australia 2000
38 Sydney Retina Clinic and Day Surgery Sydney New South Wales Australia 2000
39 Centre For Eye Research Australia East Melbourne Victoria Australia 3002
40 Retina Specialists Victoria Rowville Victoria Australia 3178
41 Specjalistyczny Ośrodek Okulistyczny Oculomedica Bydgoszcz Poland 85-870
42 Gabinet Okulistyczny Prof Edward Wylegala Katowice Poland 40-594
43 Centrum Medyczne UNO-MED Krakow Poland 31-070
44 Centrum Diagnostyki i Mikrochirurgii Oka LENS Olsztyn Poland 10-424
45 LensClinic Rybnik Poland 44-203
46 Centrum Medyczne Julianow; Zeglarska Łódź Poland 91-321
47 Emanuelli Research and Development Center LLC Arecibo Puerto Rico 00612
48 Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica Slovakia 975 17
49 Klinika Oftalmológie LFUK a UNB Bratislava Slovakia 826 06
50 Očná klinika UNB a SZU Bratislava Slovakia 851 07
51 3F s.r.o Košice Slovakia 040 11
52 Fakultna nemocnica Trencin Trencin Slovakia 911 71
53 Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie Zilina Slovakia 012 07
54 Hospital Universitari de Bellvitge; Servicio de Oftalmologia Hospitalet De Llobregat Barcelona Spain 8907
55 Hospital General de Catalunya San Cugat Del Valles Barcelona Spain 08195
56 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222
57 Hospital Dos de Maig Barcelona Spain 08025
58 Hospital Clinic I Provincial Barcelona Spain 08036
59 Clinica Barraquer Barcelona Spain 8021
60 Pio del Rio Hortega University Hospital Valladolid Spain 47012
61 Miguel Servet University Hospital Zaragoza Spain 50009
62 Royal Victoria Hospital; Outpatients Department Belfast United Kingdom BT12 6BA
63 Colchester General Hospital Colchester, Essex United Kingdom CO4 5JL
64 Royal Surrey County Hospital; Eye Clinic Research office Guilford United Kingdom GU2 7XX
65 Hull University Teaching Hospitals NHS Trust Hull United Kingdom HU3 2JZ
66 Royal Liverpool University Hospital Liverpool United Kingdom L7 8XP
67 Nottingham University Hospitals NHS Trust Nottingham United Kingdom NG7 2UH
68 Sunderland Eye Infirmary Sunderland United Kingdom SR2 9HP

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:
Aug 22, 2022
Last Verified:
Aug 1, 2022
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:
Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Aug 22, 2022