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Trial registered on ANZCTR


Registration number
ACTRN12623000215628
Ethics application status
Approved
Date submitted
13/12/2022
Date registered
28/02/2023
Date last updated
28/02/2023
Date data sharing statement initially provided
28/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the Efficacy and Durability of Faricimab in Patients Currently Treated for Neovascular Age-Related Macular Degeneration.
Scientific title
A Phase IV, Prospective, Open Labelled, Single-arm, Multi-centered Study Assessing the Efficacy and Durability of Faricimab in Patients Currently Treated for Neovascular Age-Related Macular Degeneration.
Secondary ID [1] 308611 0
Sponsor: CUREOS
Protocol Number: CUR-001-22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration 328505 0
Condition category
Condition code
Eye 325531 325531 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravitreal injections of faricimab 6mg/0.05mL will be delivered by the treating ophthalmologist at each site. Following four monthly loading doses, all patients will receive treatment under a treat-and-extend regimen until 12 months post baseline. Under the treat-and-extend regimen, the interval between treatments will be extended or reduced (determined by the treating ophthalmologist) depending on if there is disease activity present. Treatment intervals range from 4-weekly dosing to 16-weekly intervals. Treatment will be administered at each study visit. Study visits will align with treatment requirements during the treat-and-extend period. Study staff will schedule study visits with patients within a specified visit window (+-1 week). Ongoing communication between study staff and patients between study visits will ensure treatment adherence.

At each visit, a variety of ocular imaging procedures and assessments will be conducted to monitor the ocular health of the eye and assess visual function prior to treatment administration.
Intervention code [1] 325059 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333369 0
Change from Baseline in best-corrected visual acuity (BCVA), assessed using a 4-meter Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Timepoint [1] 333369 0
Baseline and Weeks 12, 24 and 52 (primary endpoint)
Secondary outcome [1] 416774 0
Proportion of patients on different treatment intervals (4-weekly, 8-weekly, 12-weekly and 16-weekly). Treatment interval will be determined using the interval listed in study visit record at the previous treatment visit.
Timepoint [1] 416774 0
Week 52
Secondary outcome [2] 416775 0
Number of injections received as recorded in study source documents (patient medical record).
Timepoint [2] 416775 0
Week 52
Secondary outcome [3] 416776 0
Proportions of patients gaining greater than or equal to 15, 10, or 5 letters in BCVA, assessed using a 4-meter ETDRS chart.
Timepoint [3] 416776 0
Baseline and Weeks 12, 24 and 52
Secondary outcome [4] 416777 0
Proportions of patients losing greater than or equal 15, 10, or 5 letters in BCVA, assessed using a 4-meter ETDRS chart.
Timepoint [4] 416777 0
Baseline and Weeks 12, 24 and 52
Secondary outcome [5] 416778 0
Change from Baseline in macular function measured via microperimetry.
Timepoint [5] 416778 0
Baseline and Weeks 12, 24 and 52
Secondary outcome [6] 416779 0
Change from Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) score.
Timepoint [6] 416779 0
Baseline and Weeks 12, 24 and 52
Secondary outcome [7] 416780 0
Change from Baseline in central macular thickness (CMT) measured by optical coherence tomography (OCT).
Timepoint [7] 416780 0
Baseline and Weeks 12, 24 and 52
Secondary outcome [8] 416781 0
Proportion of subjects with fluid-free (absence of intra-retinal, sub-retinal or sub-retinal pigment epithelial fluid) status on OCT
Timepoint [8] 416781 0
Weeks 4, 12, 24 and 52
Secondary outcome [9] 416782 0
Proportion of subjects developing fibrosis on OCT
Timepoint [9] 416782 0
Weeks 12, 24 and 52
Secondary outcome [10] 416783 0
Change from baseline in choroidal neovascularization lesion size on OCT.
Timepoint [10] 416783 0
Baseline and Weeks 12, 24 and 52
Secondary outcome [11] 416786 0
Frequency and severity of ocular and systemic adverse events (AEs). This will be assessed as a composite outcome graded via Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Timepoint [11] 416786 0
Weeks 12, 24 and 52
Secondary outcome [12] 417132 0
Proportion of subjects developing macular atrophy on OCT
Timepoint [12] 417132 0
Weeks 12, 24 and 52

Eligibility
Key inclusion criteria
1. BCVA better than 20 letters as measured by an ETDRS chart (Snellen equivalent 6/120)
2. Previously treated neovascular age-related macular degeneration (nAMD), diagnosed within 36 months of the screening visit:
a. Subjects must have had at least 3 consecutive monthly injections (loading/initiation phase) of an anti-VEGF (ranibizumab or aflibercept) with a demonstrated early treatment response. An early treatment response is defined as:
i. Any reduction in retinal exudation (IRF and/or SRF) within the first 4 months of anti-VEGF treatment
b. Previous treatment with a single anti-VEGF agent (ranibizumab or aflibercept) following a treat-and-extend principle
c. First anti-VEGF injection within 36 months at screening
d. Most recent anti-VEGF injection between 1-3 months at screening
3. Active CNV, secondary to age-related macular degeneration (AMD) affecting the central subfield at screening
a. Active CNV is considered to be evidence of recurrent IRF and/or SRF affecting the central 3-mm subfield of the study eye, confirmed by confirmed by the Principal Investigator and central reading center (CRC) using spectral-domain optical coherence tomography (SD-OCT) and angiography
4. Availability of historical OCT imaging to demonstrate treatment response
5. Availability of comprehensive historical anti-VEGF injection data including anti-VEGF agent administered, total number and date of administration from the first anti-VEGF treatment for nAMD.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unless specified otherwise, ocular specific exclusion criteria apply to the study eye only.
1. CNV or retinal exudation due to causes other than typical AMD, such as vitelliform macular dystrophy, ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
2. Active intraocular inflammation or suspected or active intraocular or periocular infection (eg, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Baseline
3. Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by colour fundus photography autofluorescence.
4. Subretinal blood affecting the central subfield and/or greater than or equal to 50% of the lesion of the study eye
5. Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than neovascular AMD, that, in the judgment of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product
o Cataract surgery during the study is permitted at the discretion of the investigator.
6. Retinal pigment epithelium (RPE) rip/tear in the study eye at Baseline
7. Current vitreous haemorrhage or history of vitreous haemorrhage in the study eye within 4 weeks prior to Baseline
8. History of rhegmatogenous retinal detachment, stage 3/4 macular hole or any retinal break unless adequate repair has been performed
9. History of the following in the study eye:
o Previous pars plana vitrectomy
o Previous treatment with anti-VEGF other than ranibizumab or aflibercept (e.g. brolucizumab or bevacizumab)
o Previous photodynamic therapy (PDT)
o Intraocular or refractive surgery within the 90-day period prior to Baseline
o Previous penetrating keratoplasty or vitrectomy
o Previous panretinal photocoagulation
o Previous submacular surgery, other surgical intervention or laser treatment for AMD
10. Uncontrolled glaucoma or ocular hypertension in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator’s judgment at Baseline
11. Intra- or periocular use of corticosteroids in the study eye during the 6-month period prior to Baseline
12. Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within the 90-day period prior to Baseline
13. Use of systemic corticosteroids for 30 or more consecutive days within the 90 days prior to Baseline, with the exception of low stable doses of corticosteroids (defined as less than or equal to 10 mg prednisolone or equivalent dose used for 90 days or more). Inhaled, nasal or dermal steroids are also permitted
14. Previous therapeutic radiation near the region of the study eye
15. History of a medical condition (disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product
16. History of hypersensitivity to any component of the test article or clinically relevant sensitivity to fluorescein dye (or indocyanine green), as assessed by the Investigator
17. Participation in an investigational drug, biologic, or device study within 30 days or the duration of 5 half-lives of the investigational product (whichever is longer) prior to Baseline
o Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary
18. Systemic anti-vascular endothelial growth factor (VEGF) therapy within the 90-day period prior to Baseline
19. Stroke or myocardial infarction in the 90-day period prior to Baseline
20. Uncontrolled blood pressure defined as a systolic value greater than or equal to 160 mmHg and/or diastolic value greater than or equal to 100 mmHg at Screening
21. Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the study period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections

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



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 150 subjects was chosen to provide a 95% confidence interval margin on BCVA gain at 1 year within 5-letters.

Descriptive statistics will be used to present efficacy and safety variables (at Baseline, Weeks 4, 12, 24 and 52). Mean values + 95% confidence intervals will be used for continuous variables (e.g. BCVA, CMT, CNV lesion size, macular function, number of injections) while frequency counts and percentages (+95% confidence intervals) will be used for categorical values (e.g. fluid status, fibrosis, macular atrophy, current treatment interval, ocular and systemic AE’s). Changes in continuous endpoints will be compared using an ANCOVA model while categorical endpoints will be compared using chi-square tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment outside Australia
Country [1] 25268 0
Singapore
State/province [1] 25268 0

Funding & Sponsors
Funding source category [1] 312855 0
Commercial sector/Industry
Name [1] 312855 0
Roche
Country [1] 312855 0
Australia
Primary sponsor type
Other Collaborative groups
Name
CUREOS
Address
Level 6/187 Macquarie St, Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 314505 0
None
Name [1] 314505 0
None
Address [1] 314505 0
None
Country [1] 314505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312133 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 312133 0
Ethics committee country [1] 312133 0
Australia
Date submitted for ethics approval [1] 312133 0
30/01/2023
Approval date [1] 312133 0
28/02/2023
Ethics approval number [1] 312133 0
2022-12-1388

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

Contacts
Principal investigator
Name 123594 0
A/Prof Andrew Chang
Address 123594 0
Sydney Retina, Level 13/187 Macquarie St, Sydney NSW 2000
Country 123594 0
Australia
Phone 123594 0
+61292213755
Fax 123594 0
Email 123594 0
achang@sydneyretina.com.au
Contact person for public queries
Name 123595 0
Thomas Hong
Address 123595 0
CUREOS, Level 6/187 Macquarie St, Sydney NSW 2000
Country 123595 0
Australia
Phone 123595 0
+61292213755
Fax 123595 0
Email 123595 0
thomas.hong@cureos.com.au
Contact person for scientific queries
Name 123596 0
Thomas Hong
Address 123596 0
CUREOS, Level 6/187 Macquarie St, Sydney NSW 2000
Country 123596 0
Australia
Phone 123596 0
+61292213755
Fax 123596 0
Email 123596 0
thomas.hong@cureos.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.