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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06795048




Registration number
NCT06795048
Ethics application status
Date submitted
24/01/2025
Date registered
27/01/2025

Titles & IDs
Public title
A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Scientific title
A Phase IIIb/IV, Multicenter, Randomized, Open-Label, Two-Arm Study to Investigate the Efficacy, Safety, and Durability of Faricimab Administered up to Every 24 Weeks in Patients With Neovascular Age-Related Macular Degeneration
Secondary ID [1] 0 0
2024-517545-13-00
Secondary ID [2] 0 0
MR45638
Universal Trial Number (UTN)
Trial acronym
CONSTANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration (nAMD) 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

Experimental: Arm A: Faricimab Early Treat & Extend Regimen -

Experimental: Arm B: Faricimab Modified Treat & Extend Regimen -


Treatment: Drugs: Faricimab
Participants will receive 6-mg faricimab intravitreal (IVT) injections in the study eye according to the dosing regimen for the study arm to which they are randomized.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52
Timepoint [1] 0 0
Baseline and average of Weeks 44, 48, and 52
Secondary outcome [1] 0 0
Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100
Timepoint [1] 0 0
Baseline and average of Weeks 92, 96, and 100
Secondary outcome [2] 0 0
Change from Baseline in BCVA Score Over Time
Timepoint [2] 0 0
From Baseline to Week 100
Secondary outcome [3] 0 0
Percentage of Participants Avoiding a Loss of =15 Letters in BCVA from Baseline Over Time
Timepoint [3] 0 0
From Baseline to Week 100
Secondary outcome [4] 0 0
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
Timepoint [4] 0 0
From Baseline to Week 100
Secondary outcome [5] 0 0
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
Timepoint [5] 0 0
From Baseline to Week 100
Secondary outcome [6] 0 0
Change from Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44, 48, and 52
Timepoint [6] 0 0
Baseline and average of Weeks 44, 48, and 52
Secondary outcome [7] 0 0
Change from Baseline in CST Averaged Over Weeks 92, 96, and 100
Timepoint [7] 0 0
Baseline and average of Weeks 92, 96, and 100
Secondary outcome [8] 0 0
Change from Baseline in CST Over Time
Timepoint [8] 0 0
From Baseline to Week 100
Secondary outcome [9] 0 0
Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100
Timepoint [9] 0 0
Weeks 52 and 100
Secondary outcome [10] 0 0
Incidence and Severity of Ocular Adverse Events
Timepoint [10] 0 0
From first study treatment to Week 100
Secondary outcome [11] 0 0
Incidence and Severity of Non-Ocular Adverse Events
Timepoint [11] 0 0
From first study treatment to Week 100

Eligibility
Key inclusion criteria
* Overtly healthy as determined by medical evaluation that includes medical history and physical examination
* Agreement to adhere to the contraception requirements described in the protocol

Ocular Inclusion Criteria for Study Eye:

* Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT)
* BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study [ETDRS] protocol and addressed at the initial testing distance of 4 meters on Day 1)
* Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ocular Exclusion Criteria for Study Eye:

* MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
* Retinal pigment epithelial tear involving the macula on Day 1
* Current vitreous hemorrhage on Day 1
* Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor [VEGF], or complement inhibitor medication) for other retinal diseases

Ocular Exclusion Criteria for Fellow (Non-Study) Eye:

* Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits

Ocular Exclusion for Both Eyes:

* History of idiopathic or autoimmune associated uveitis in either eye
* Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
14/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2028
Actual
Sample size
Target
274
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Strathfield Retina Clinic - Strathfield
Recruitment hospital [2] 0 0
Adelaide Eye and Retina Centre - Adelaide
Recruitment hospital [3] 0 0
Retina Specialists Victoria - Rowville
Recruitment postcode(s) [1] 0 0
2135 - Strathfield
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3178 - Rowville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Taiwan
State/province [4] 0 0
Kaohsiung

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
Reference Study ID Number: MR45638 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06795048