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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04432831




Registration number
NCT04432831
Ethics application status
Date submitted
12/06/2020
Date registered
16/06/2020
Date last updated
3/05/2021

Titles & IDs
Public title
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
Scientific title
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema
Secondary ID [1] 0 0
2020-000402-29
Secondary ID [2] 0 0
GR41987
Universal Trial Number (UTN)
Trial acronym
Rhone-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Faricimab
Other interventions - Sham Procedure

Experimental: Faricimab PTI -


Treatment: Drugs: Faricimab
Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.

Other interventions: Sham Procedure
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Severity of Ocular Adverse Events
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Incidence and Severity of Systemic (Non-Ocular) Adverse Events
Timepoint [2] 0 0
Up to 2 years
Primary outcome [3] 0 0
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
Timepoint [3] 0 0
From Baseline up to 2 years

Eligibility
Key inclusion criteria
- Previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398
(NCT03622593), without study or study drug discontinuation

- Ability to comply with the study protocol, in the investigator's judgment

- For women of childbearing potential: agreement to remain abstinent or use acceptable
contraceptive methods that result in a failure rate of <1% per year during the
treatment period and for at least 3 months after the final dose of study treatment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or breastfeeding, or intending to become pregnant during the study or within
28 days after the final intravitreal injection of faricimab

- Presence of other ocular diseases that give reasonable suspicion of a disease or
condition that contraindicates the use of faricimab, that might affect interpretation
of the results of the study or that renders the patient at high risk for treatment
complications

- Presence of other diseases, metabolic dysfunction, or clinical laboratory finding
giving reasonable suspicion of a disease or condition that contraindicates the use of
faricimab and that might affect interpretation of the results of the study or that
renders the patient at high risk of treatment complications

- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or
known hypersensitivity to any component of the faricimab injections, study treatment
procedure, dilating drops, or any of the anesthetic and antimicrobial preparations
used by a patient during the study

- Requirement for continuous use of any medications or treatments indicated as
prohibited therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [2] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney Retina Clinic and Day Surgery - Sydney
Recruitment hospital [4] 0 0
Sydney West Retina - Westmead
Recruitment hospital [5] 0 0
Centre For Eye Research Australia - East Melbourne
Recruitment hospital [6] 0 0
Retina Specialists Victoria - Rowville
Recruitment hospital [7] 0 0
The Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2135 - Strathfield
Recruitment postcode(s) [2] 0 0
2000 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3178 - Rowville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter long-term extension study designed to evaluate the long-term safety and
tolerability of faricimab administered by intravitreal (IVT) injection at a personalized
treatment interval (PTI) to participants who enrolled in and completed one of the two Phase
III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent
studies.
Trial website
https://clinicaltrials.gov/show/NCT04432831
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
Reference Study ID Number: GR41987 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. only)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04432831