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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04777201




Registration number
NCT04777201
Ethics application status
Date submitted
26/02/2021
Date registered
2/03/2021
Date last updated
7/03/2024

Titles & IDs
Public title
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Scientific title
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X)
Secondary ID [1] 0 0
2020-004523-16
Secondary ID [2] 0 0
GR42691
Universal Trial Number (UTN)
Trial acronym
AVONELLE-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

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

Experimental: Main Study: Faricimab PTI -

Experimental: Substudy: Faricimab PTI -


Treatment: Drugs: Faricimab
Faricimab 6 mg will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.

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 12 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
Main Study: Incidence and Severity of Ocular Adverse Events
Timepoint [1] 0 0
Up to 2 years
Primary outcome [2] 0 0
Main Study: Incidence and Severity of Systemic (Non-Ocular) Adverse Events
Timepoint [2] 0 0
Up to 2 years
Primary outcome [3] 0 0
Main Study: 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
Primary outcome [4] 0 0
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye
Timepoint [4] 0 0
Baseline and 1 year
Secondary outcome [1] 0 0
Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye
Timepoint [1] 0 0
Baseline and Week 24

Eligibility
Key inclusion criteria
Inclusion Criteria for the Main Study:

- Previous enrollment in and completion of Study GR40306 (NCT03823287) or Study GR40844
(NCT03823300), without study or study drug discontinuation

- For women of childbearing potential: agreement to remain abstinent or use
contraception, and agreement to refrain from donating eggs. Women must remain
abstinent or use contraceptive methods with a failure rate of < 1% per year during the
treatment period and for 3 months after the final dose of faricimab. Women must
refrain from donating eggs during the same period.

Inclusion Criteria for the Substudy:

- In addition to all inclusion criteria specified in the main Study GR42691,
participants in the Substudy must meet the following criteria:

- Sign an informed consent form for the Substudy

- Must be able to participate for at least 48 weeks in the Substudy and have at least
the first visit while enrolled in the main Study GR42691

- A difference of <10% in corneal endothelial cell density at screening between the two
eyes as measured by specular microscopy and determined by the independent reading
center
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria for the Main Study:

- Pregnant or breastfeeding, or intending to become pregnant during the study or within
3 months after the final dose 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-related
procedure preparations, 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

Exclusion Criteria for the Substudy:

In addition to the exclusion criteria specified in the main Study GR42691, patients will be
excluded from this substudy if they meet any of the following exclusion criteria:

- Prior and/or current administration of faricimab in the fellow (non-study) eye

- Prior administration of brolucizumab in the fellow (non-study) eye

Exclusion Criteria in Either Eye for the Substudy:

- Corneal endothelial cell density =1500 cells/mm2 in either eye at screening as
determined by the independent corneal reading center

- Fuchs endothelial corneal dystrophy Grade =2

- Previous ocular trauma (blunt or penetrating) and/or corneal endothelial cell damage,
including from blunt or surgical trauma (including complicated cataract surgery
resulting in complicated lens placement such as anterior chamber intraocular lens,
sulcus intraocular lens, aphakia, etc.)

- Any ocular condition that precludes obtaining an analyzable specular microscopy image

- Active or history of corneal edema

- Any active or history of corneal dystrophies, excluding Fuchs endothelial corneal
dystrophy Grade <2

- Active or history of iridocorneal endothelial syndrome

- Active or history of pseudoexfoliation syndrome

- Active or history of herpetic keratitis or kerato-uveitis (including herpes simplex
virus and herpes zoster virus)

- Intraocular laser therapy including selective laser trabeculoplasty, yttrium-aluminum
garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG
capsulotomy within 3 months of screening

- Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD

- Prior pars plana vitrectomy surgery

- Previous intraocular device implantation excluding intraocular lenses

- Cataract surgery within 6 months of screening or planned for during the study

- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery.
Other types of prior glaucoma surgery are allowed providing that the surgery occur
more than 6 months before screening

- Administration of topical Rho kinase inhibitors (e.g., Rhopressa eye drops) within 1
month prior to the screening visit

- Contact lens wear in either eye within 2 months of screening

- History of corneal transplantation, including partial-thickness corneal grafts (e.g.,
Descemet membrane endothelial keratoplasty, Descemet stripping endothelial
keratoplasty)

- Active or history of iridocorneal endothelial syndrome

- Active or history of pseudoexfoliation syndrome

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/08/2024
Actual
Sample size
Target
Accrual to date
Final
1036
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Eyeclinic Albury Wodonga - Albury
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Strathfield Retina Clinic - Strathfield
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Sydney Eye Hospital - Sydney
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Sydney Retina Clinic and Day Surgery - Sydney
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Sydney West Retina - Westmead
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Centre For Eye Research Australia - East Melbourne
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Retina Specialists Victoria - Rowville
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The Lions Eye Institute - Nedlands
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2640 - Albury
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2135 - Strathfield
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2000 - Sydney
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2145 - Westmead
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3002 - East Melbourne
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3178 - Rowville
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6009 - Nedlands
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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 main long-term extension study is designed to evaluate the long-term safety and
tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a
personalized treatment interval (PTI) to participants with neovascular age-related macular
degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306
(NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible
patients who consent to participate in this main study will be enrolled upon completion of
the end-of-study visit in the parent study.

Additionally, there is a substudy that is being conducted. The aim of this substudy is to
evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells
in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA)
post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy
will serve as the controls.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04777201
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/ct2/show/NCT04777201