Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04265261




Registration number
NCT04265261
Ethics application status
Date submitted
5/02/2020
Date registered
11/02/2020

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2019-002067-10
Secondary ID [2] 0 0
BP41321
Universal Trial Number (UTN)
Trial acronym
CANBERRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Retinopathy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - RG7774

Placebo comparator: Group A - Participants will receive an oral dose of placebo matched to RG7774 once daily (QD)

Experimental: Group B - Participants will receive a low oral dose of RG7774 QD

Experimental: Group C - Participants will receive a high oral dose of RG7774 QD


Treatment: Drugs: Placebo
Participants will receive oral placebo matched to RG7774

Treatment: Drugs: RG7774
Participants will receive oral RG7774
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 36
Primary outcome [2] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
From baseline up to 52 weeks
Secondary outcome [1] 0 0
Percentage of Participants with Anterior Segment Neovascularization (ASNV), new Proliferative Diabetic Retinopathy (PDR), new Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention
Timepoint [1] 0 0
From baseline up to 52 weeks
Secondary outcome [2] 0 0
Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Timepoint [2] 0 0
Baseline; Week 36

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/07/2023
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [3] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [4] 0 0
Retina Specialists Victoria - Rowville
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
3178 - Rowville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
Poland
State/province [21] 0 0
?ód?
Country [22] 0 0
Poland
State/province [22] 0 0
Katowice
Country [23] 0 0
Poland
State/province [23] 0 0
Krakow
Country [24] 0 0
Poland
State/province [24] 0 0
Olsztyn
Country [25] 0 0
Poland
State/province [25] 0 0
Rybnik
Country [26] 0 0
Puerto Rico
State/province [26] 0 0
Arecibo
Country [27] 0 0
Slovakia
State/province [27] 0 0
Banska Bystrica
Country [28] 0 0
Slovakia
State/province [28] 0 0
Bratislava
Country [29] 0 0
Slovakia
State/province [29] 0 0
Košice
Country [30] 0 0
Slovakia
State/province [30] 0 0
Trencin
Country [31] 0 0
Slovakia
State/province [31] 0 0
Zilina
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Spain
State/province [34] 0 0
Valladolid
Country [35] 0 0
Spain
State/province [35] 0 0
Zaragoza
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Belfast
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Colchester, Essex
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Guilford
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Hull
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Liverpool
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Nottingham
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Sunderland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04265261