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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
Date last updated
25/09/2024

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
Up to 1 year (baseline through follow-up period)
Secondary outcome [1] 0 0
Time-to-Event for Vision-Threatening DR in the Study Eye
Timepoint [1] 0 0
Up to Day 277
Secondary outcome [2] 0 0
Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye
Timepoint [2] 0 0
Week 36
Secondary outcome [3] 0 0
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36
Timepoint [3] 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
139
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
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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Florida
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Georgia
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Illinois
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Maryland
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Michigan
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Mississippi
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Nevada
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New Jersey
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United States of America
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New Mexico
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New York
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North Carolina
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Oregon
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Poland
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?ód?
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Olsztyn
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Poland
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Rybnik
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Puerto Rico
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Arecibo
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Košice
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Slovakia
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Trencin
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Slovakia
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Zilina
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valladolid
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Spain
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Zaragoza
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United Kingdom
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Belfast
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United Kingdom
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Colchester, Essex
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United Kingdom
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Guilford
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United Kingdom
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Hull
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United Kingdom
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Liverpool
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United Kingdom
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Nottingham
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT04265261
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04265261