Study to Evaluate Faricimab (RO6867461; RG7716) for Exten... | NCT03038880 | Trialant
NCT03038880
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Jan 5, 2021Actual
Enrollment
76Actual
Phase
Phase 2
Conditions
Neovascularization, Choroidal
Macular Degeneration, Age-Related
Interventions
Faricimab
Ranibizumab
Sham Procedure
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03038880
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR39521
Secondary IDs
Not provided
Brief Title
Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration
Official Title
STAIRWAY: Simultaneous Blockade of Angiopoietin-2 and VEGF-A With the Bispecific Antibody RO6867461 (RG7716) for Extended Durability in the Treatment of Neovascular Age-Related Macular Degeneration
Acronym
STAIRWAY
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Dec 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 27, 2017Actual
Primary Completion Date
Jan 11, 2018Actual
Completion Date
Mar 29, 2018Actual
First Submitted Date
Jan 31, 2017
First Submission Date that Met QC Criteria
Jan 31, 2017
First Posted Date
Feb 1, 2017Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 9, 2020
Results First Submitted that Met QC Criteria
Dec 9, 2020
Results First Posted Date
Jan 5, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 11, 2019
Certification/Extension First Submitted that Passed QC Review
Jan 11, 2019
Certification/Extension First Posted Date
Jan 15, 2019Actual
Last Update Submitted Date
Dec 9, 2020
Last Update Posted Date
Jan 5, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a Phase II, multicenter, randomized, active comparator-controlled, 52-week study to investigate the efficacy, safety and pharmacokinetics of faricimab (RO6867461; RG7716) administered with extended dosing regimens in treatment-naive participants with neovascular age related macular degeneration (nAMD). Only one eye was chosen as the study eye.
Detailed Description
Not provided
Conditions Module
Conditions
Neovascularization, Choroidal
Macular Degeneration, Age-Related
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
76Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
6 mg Faricimab Q12W
Experimental
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
Drug: Faricimab
Drug: Sham Procedure
6 mg Faricimab Q16W
Experimental
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
Drug: Faricimab
Drug: Sham Procedure
0.5 mg Ranibizumab Q4W
Active Comparator
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Drug: Ranibizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Faricimab
Drug
Faricimab was administered via IVT injections as specified during the treatment period.
6 mg Faricimab Q12W
6 mg Faricimab Q16W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 40, Using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA Charts
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline BCVA.
Baseline, Week 40
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline BCVA.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Treatment-naive CNV secondary to AMD (nAMD)
Subfoveal or juxtafoveal CNV with a subfoveal component related to the CNV activity by fundus fluorescein angiography (FFA) or spectral-domain optical coherence tomography (SD-OCT; as evidenced by subretinal fluid, subretinal hyperreflective material, evidence of leakage, or hemorrhage)
CNV lesion of all types with: total lesion size (including blood, atrophy, fibrosis, and neovascularization) of 6 disc areas or less by FFA; and CNV component area of at least 50% of total lesion size by FFA; and active CNV confirmed by FFA (evidence of leakage); and CNV exudation confirmed by SD-OCT (presence of fluid)
BCVA letter score of 73 to 24 letters (inclusive) on ETDRS-like charts (20/40-20/320 Snellen equivalent) on day 1
Clear ocular media and adequate pupillary dilatation to allow acquisition of good-quality retinal images to confirm diagnosis
Exclusion Criteria:
CNV due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
Central serous chorioretinopathy at screening
Retinal pigment epithelial tear involving the macula
On FFA: subretinal hemorrhage, fibrosis, or atrophy of more than (>)50% of the total lesion area and/or that involves the fovea
Any prior or concomitant treatment for CNV including (but not restricted to) IVT treatment (steroids, anti-VEGF, tissue plasminogen activator, ocriplasmin, C3F8 gas, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or surgical intervention
Cataract surgery within 3 months of baseline assessments
Any other intraocular surgery (pars plana vitrectomy, glaucoma surgery, corneal transplant, radiotherapy)
Prior IVT treatment (including anti-VEGF medication) except for management of cataract complication with steroid IVT treatment
Prior periocular pharmacological intervention for other retinal diseases
Any concurrent intraocular condition in the study eye (eg, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the course of the study
Active intraocular inflammation (grade trace or above) in the study eye on day 1 (before randomization)
Current vitreous hemorrhage in the study eye
Uncontrolled glaucoma (eg, progressive loss of visual fields or defined as IOP ≥25 mm Hg despite treatment with antiglaucoma medication) in the study eye
Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia in the study eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye on day 1 (before randomization)
Any major illness or major surgical procedure within 1 month before screening
Uncontrolled blood pressure (defined as systolic >180 mm Hg and/or diastolic >100 mm Hg while participant at rest). If a participant's initial reading exceeded these values, a second reading was taken later on the same day, or on another day during the screening period. If the participant's blood pressure was controlled by antihypertensive medication, the participant was taking the same medication continuously for at least 30 days before day 1
Stroke or myocardial infarction within 3 months before day 1
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory findings giving reasonable suspicion of a condition that contraindicated the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
Pregnant or breastfeeding, or intended to become pregnant during the study
Known hypersensitivity to ranibizumab, fluorescein, any ingredients of the formulation used, dilating eye drops, or any of the anesthetic and antimicrobial drops used
Treatment with investigational therapy within 3 months before initiation of study treatment
Khanani AM, Patel SS, Ferrone PJ, Osborne A, Sahni J, Grzeschik S, Basu K, Ehrlich JS, Haskova Z, Dugel PU. Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):964-972. doi: 10.1001/jamaophthalmol.2020.2699.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
3
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Feb 14, 2017
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantOutcomes Assessor
RO6867461
RG7716
Ranibizumab
Drug
Ranibizumab was administered via IVT injections as specified during the treatment period.
0.5 mg Ranibizumab Q4W
Lucentis®
Sham Procedure
Drug
The sham was a procedure that mimicked an IVT injection and involved the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in the faricimab treatments arms at applicable visits to maintain masking among treatment arms.
6 mg Faricimab Q12W
6 mg Faricimab Q16W
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a loss in BCVA letter score from baseline indicates worsening in visual acuity. This analysis was performed on observed data.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Central foveal thickness (CFT) was defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea, and it was measured using spectral domain optical coherence tomography (SD-OCT). The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline CFT.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Central subfield thickness (CST) was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield, and it was measured using spectral domain optical coherence tomography (SD-OCT). The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline CST.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Intraretinal fluid was defined as the presence of fluid within the retina. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Subretinal fluid was defined as the presence of fluid between the retina and the retinal pigment epithelium. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants With No Cysts at Specified Timepoints
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Cysts were defined as the presence of cystoid space (fluid) in the retina. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Pigment epithelial detachment was defined as the presence of a detachment of the pigment epithelium from the Bruch's membrane. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Mean Baseline Value and Mean Change From Baseline of Total Area of Choroidal Neovascularization (CNV) at Week 40 and Week 52
The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Baseline, Week 40, Week 52
Mean Baseline Value and Mean Change From Baseline of Total Area of CNV Component at Week 40 and Week 52
The total area of choroidal neovascularization (CNV) component (i.e., total area of CNV membrane) was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Baseline, Week 40, Week 52
Mean Baseline Value and Mean Change From Baseline of Total Area of Leakage at Week 40 and Week 52
The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Baseline, Week 40, Week 52
Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline
Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to faricimab by a validated enzyme-linked immunosorbent assay (ELISA).
Predose at Baseline (Day 1), Weeks 16, 24, 28, 44, and 52
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. The investigator independently assessed the seriousness and severity for each AE. Severity was graded according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Severity and seriousness are not synonymous; regardless of severity, some AEs may have also met seriousness criteria.
From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
Tucson
Arizona
85704
United States
California Retina Consultants
Bakersfield
California
93309
United States
Retinal Diagnostic Center
Campbell
California
95008
United States
Retina Consultants of Southern Colorado PC; Clinical Research Department
Colorado Springs
Colorado
80909-1183
United States
Rand Eye
Deerfield Beach
Florida
33064
United States
Florida Eye Associates
Melbourne
Florida
32901
United States
Retina Vitreous Assoc of FL
St. Petersburg
Florida
33711
United States
Southern Vitreoretinal Assoc
Tallahassee
Florida
32308
United States
Southeast Retina Center
Augusta
Georgia
30909
United States
Midwest Eye Institute
Indianapolis
Indiana
46290
United States
Wolfe Eye Clinic
West Des Moines
Iowa
50266
United States
The Retina Care Center
Baltimore
Maryland
21209
United States
Vitreo Retinal Surgery
Minneapolis
Minnesota
55435
United States
Sierra Eye Associates
Reno
Nevada
89502
United States
Eye Associates of New Mexico
Albuquerque
New Mexico
87109
United States
Vitreoretinal Consultants
Great Neck
New York
11021
United States
Oregon Retina, LLP
Eugene
Oregon
97401
United States
Retina Northwest
Portland
Oregon
97221
United States
Charles Retina Institute
Germantown
Tennessee
38138
United States
Retina Res Institute of Texas
Abilene
Texas
79606
United States
Texas Retina Associates
Arlington
Texas
76012
United States
Retina Research Center
Austin
Texas
78750
United States
Strategic Clinical Research Group, LLC
Willow Park
Texas
76087
United States
Retina Associates of Utah
Salt Lake City
Utah
84107
United States
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
FG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
FG00024 subjects
FG00131 subjects
FG00216 subjects
COMPLETED
FG00021 subjects
FG00128 subjects
FG00216 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0020 subjects
Type
Comment
Reasons
Death
FG0001 subjects
FG0012 subjects
FG0020 subjects
Physician Decision
FG0002 subjects
FG0011 subjects
FG0020 subjects
The efficacy population includes randomized participants grouped according to their assigned treatment. A total of 76 patients were randomized in the study, but 5 participants in total (all randomized to the 6 mg Faricimab Q12W Arm) were excluded from the analysis populations because of Good Clinical Practice (GCP) violations at a single site.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
BG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
BG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00024
BG00131
BG00216
BG00371
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00080.3± 7.23
BG00177.7± 8.38
BG00277.3± 10.29
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00118
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0000
BG0011
BG002
Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Baseline
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R). The BCVA letter score ranges from 0 to 100 (best score attainable), with a higher score indicating better visual acuity.
Mean
Standard Deviation
ETDRS Letters
Title
Denominators
Categories
Title
Measurements
BG00057.8± 10.46
BG001
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Classic and Occult CNV
BG0000
BG0012
BG002
Central Foveal Thickness in the Study Eye at Baseline
Central foveal thickness (CFT) was defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea, and it was measured using spectral domain optical coherence tomography (SD-OCT).
Mean
Standard Deviation
microns (μm)
Title
Denominators
Categories
Title
Measurements
BG000290.8± 118.61
BG001
Central Subfield Thickness in the Study Eye at Baseline
Central subfield thickness (CST) was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield, and it was measured using spectral domain optical coherence tomography (SD-OCT).
Mean
Standard Deviation
microns (μm)
Title
Denominators
Categories
Title
Measurements
BG000417.9± 84.28
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 40, Using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA Charts
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline BCVA.
Efficacy population: participants grouped according to their assigned treatment.
Posted
Least Squares Mean
80% Confidence Interval
ETDRS Letters
Baseline, Week 40
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Title
Measurements
OG0009.3(6.4 to 12.3)
OG00112.5(9.9 to 15.1)
OG00211.4(7.8 to 15.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Mean Difference (Net)
-2.1
2-Sided
80
-6.8
2.6
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Secondary
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline BCVA.
Efficacy population: participants grouped according to their assigned treatment.
Posted
Least Squares Mean
80% Confidence Interval
ETDRS Letters
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
Secondary
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Count of Participants
Participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
Secondary
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Number
80% Confidence Interval
Percentage of participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
Secondary
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a loss in BCVA letter score from baseline indicates worsening in visual acuity. This analysis was performed on observed data.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Count of Participants
Participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
Secondary
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Number
80% Confidence Interval
Percentage of participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Number
80% Confidence Interval
Percentage of participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Number
80% Confidence Interval
Percentage of participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
Secondary
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Central foveal thickness (CFT) was defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea, and it was measured using spectral domain optical coherence tomography (SD-OCT). The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline CFT.
Efficacy population: participants grouped according to their assigned treatment.
Posted
Least Squares Mean
80% Confidence Interval
microns (μm)
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
Secondary
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Central subfield thickness (CST) was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield, and it was measured using spectral domain optical coherence tomography (SD-OCT). The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline CST.
Efficacy population: participants grouped according to their assigned treatment.
Posted
Least Squares Mean
80% Confidence Interval
microns (μm)
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
Secondary
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Intraretinal fluid was defined as the presence of fluid within the retina. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Number
80% Confidence Interval
Percentage of participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
Secondary
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Subretinal fluid was defined as the presence of fluid between the retina and the retinal pigment epithelium. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Number
80% Confidence Interval
Percentage of participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
Secondary
Percentage of Participants With No Cysts at Specified Timepoints
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Cysts were defined as the presence of cystoid space (fluid) in the retina. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Number
80% Confidence Interval
Percentage of participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
Secondary
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Pigment epithelial detachment was defined as the presence of a detachment of the pigment epithelium from the Bruch's membrane. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Number
80% Confidence Interval
Percentage of participants
Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
Secondary
Mean Baseline Value and Mean Change From Baseline of Total Area of Choroidal Neovascularization (CNV) at Week 40 and Week 52
The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Mean
Standard Deviation
millimetres squared (mm^2)
Baseline, Week 40, Week 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
Secondary
Mean Baseline Value and Mean Change From Baseline of Total Area of CNV Component at Week 40 and Week 52
The total area of choroidal neovascularization (CNV) component (i.e., total area of CNV membrane) was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Mean
Standard Deviation
millimetres squared (mm^2)
Baseline, Week 40, Week 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
Secondary
Mean Baseline Value and Mean Change From Baseline of Total Area of Leakage at Week 40 and Week 52
The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Posted
Mean
Standard Deviation
millimetres squared (mm^2)
Baseline, Week 40, Week 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
0.5 mg Ranibizumab Q4W
Secondary
Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline
Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to faricimab by a validated enzyme-linked immunosorbent assay (ELISA).
Safety Population: participants who received at least one dose of study treatment, grouped according to treatment received. The analysis only included participants who received treatment with faricimab (i.e., 0.5 mg Ranibizumab Q4W arm was excluded) and had evaluable samples at baseline and/or any post-baseline timepoint.
Posted
Count of Participants
Participants
Predose at Baseline (Day 1), Weeks 16, 24, 28, 44, and 52
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
Secondary
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. The investigator independently assessed the seriousness and severity for each AE. Severity was graded according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Severity and seriousness are not synonymous; regardless of severity, some AEs may have also met seriousness criteria.
Safety Population: participants who received at least one dose of the study treatment, grouped according to treatment received.
Posted
Count of Participants
Participants
From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
ID
Title
Description
OG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
OG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
Time Frame
From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
1
24
4
24
18
24
EG001
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
2
31
3
31
22
31
EG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
0
16
0
16
13
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute left ventricular failure
Cardiac disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Atrial fibrillation
Cardiac disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Coronary artery disease
Cardiac disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Vertigo
Ear and labyrinth disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Sepsis
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Fall
Injury, poisoning and procedural complications
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Headache
Nervous system disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Ischaemic stroke
Nervous system disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Mental status changes
Psychiatric disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Conjunctival haemorrhage
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0005 affected24 at risk
EG0014 affected31 at risk
EG0024 affected16 at risk
Neovascular age-related macular degeneration
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0003 affected24 at risk
EG0010 affected31 at risk
EG0022 affected16 at risk
Eye pain
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0002 affected24 at risk
EG0010 affected31 at risk
EG0022 affected16 at risk
Retinal haemorrhage
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0002 affected24 at risk
EG0010 affected31 at risk
EG0022 affected16 at risk
Cataract
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0002 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Choroidal neovascularisation
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Dry eye
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
Maculopathy
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0012 affected31 at risk
EG0020 affected16 at risk
Ocular discomfort
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
Vitreous detachment
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Vitreous floaters
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Eye haemorrhage
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Macular oedema
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Ocular hypertension
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Optic disc haemorrhage
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Vision blurred
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Nasopharyngitis
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0004 affected24 at risk
EG0012 affected31 at risk
EG0021 affected16 at risk
Urinary tract infection
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0012 affected31 at risk
EG0021 affected16 at risk
Influenza
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0012 affected31 at risk
EG0020 affected16 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Fungal skin infection
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Tooth infection
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Vaginal infection
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Fall
Injury, poisoning and procedural complications
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0015 affected31 at risk
EG0021 affected16 at risk
Muscle strain
Injury, poisoning and procedural complications
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0012 affected31 at risk
EG0020 affected16 at risk
Rib fracture
Injury, poisoning and procedural complications
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0012 affected31 at risk
EG0020 affected16 at risk
Eye contusion
Injury, poisoning and procedural complications
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Constipation
Gastrointestinal disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Pain
General disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
Cyst
General disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Biopsy palate
Investigations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 20.1
Systematic Assessment
EG0002 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Anxiety
Psychiatric disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0012 affected31 at risk
EG0020 affected16 at risk
Hypothyroidism
Endocrine disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0012 affected31 at risk
EG0020 affected16 at risk
Hypertension
Vascular disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0021 affected16 at risk
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Headache
Nervous system disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Nephrolithiasis
Renal and urinary disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Anterior chamber flare
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Chalazion
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Eye irritation
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Eye pruritus
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Foreign body sensation in eyes
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Iritis
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Subretinal fibrosis
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Visual acuity reduced
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Punctate keratitis
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Sinusitis
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Abscess limb
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Catheter site infection
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Cellulitis
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Ear infection
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Gastroenteritis
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Gastroenteritis viral
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Joint abscess
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Mycobacterium avium complex infection
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Rhinitis
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Subcutaneous abscess
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Urethritis
Infections and infestations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Hiatus hernia
Gastrointestinal disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Fatigue
General disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Inflammatory pain
General disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Blood sodium decreased
Investigations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Catheterisation cardiac
Investigations
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Hypotension
Vascular disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Aortic stenosis
Vascular disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Arrhythmia
Cardiac disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Cerebral infarction
Nervous system disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Cerebral small vessel ischaemic disease
Nervous system disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Iron deficiency
Metabolism and nutrition disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Bladder pain
Renal and urinary disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Cholecystitis
Hepatobiliary disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Hypersensitivity
Immune system disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Chorioretinal atrophy
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Macular fibrosis
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Retinal drusen
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Vitreous disorder
Eye disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Eye naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 20.1
Systematic Assessment
EG0001 affected24 at risk
EG0010 affected31 at risk
EG0020 affected16 at risk
Aneurysm
Vascular disorders
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0011 affected31 at risk
EG0020 affected16 at risk
Intraocular pressure increased
Investigations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Ophthalmological examination abnormal
Investigations
MedDRA version 20.1
Systematic Assessment
EG0000 affected24 at risk
EG0010 affected31 at risk
EG0021 affected16 at risk
Interpretability of the imaging endpoints is limited by the relatively small sample size of the study and imbalances between the arms at baseline. Formal comparisons could not be performed across the treatment arms.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Day 7
Title
Measurements
OG0003.78(2.33 to 5.24)
OG0014.62(3.33 to 5.91)
OG0023.53(1.74 to 5.33)
Week 4
Title
Measurements
OG0005.99(4.10 to 7.88)
OG0017.55(5.88 to 9.22)
OG0027.53(5.21 to 9.86)
Week 8
Title
Measurements
OG0005.28(2.88 to 7.69)
OG0019.15(7.01 to 11.29)
OG00210.55(7.55 to 13.54)
Week 12
Title
Measurements
OG0007.31(4.87 to 9.75)
OG00110.19(8.04 to 12.34)
OG0029.91(6.94 to 12.88)
Week 16
Title
Measurements
OG0008.31(5.93 to 10.68)
OG00111.62(9.52 to 13.71)
OG00210.78(7.89 to 13.68)
Week 20
Title
Measurements
OG0008.02(5.35 to 10.69)
OG00110.40(8.05 to 12.76)
OG00211.53(8.28 to 14.78)
Week 24
Title
Measurements
OG0008.11(5.53 to 10.69)
OG00110.37(8.10 to 12.65)
OG00210.97(7.83 to 14.11)
Week 28
Title
Measurements
OG0009.59(7.06 to 12.12)
OG00111.82(9.59 to 14.05)
OG00212.16(9.08 to 15.23)
Week 32
Title
Measurements
OG0009.87(7.21 to 12.53)
OG00112.44(10.10 to 14.79)
OG00211.91(8.67 to 15.14)
Week 36
Title
Measurements
OG0009.01(6.14 to 11.87)
OG00112.38(9.86 to 14.90)
OG00212.03(8.57 to 15.50)
Week 40
Title
Measurements
OG0009.33(6.37 to 12.29)
OG00112.47(9.86 to 15.08)
OG00211.42(7.83 to 15.01)
Week 44
Title
Measurements
OG0009.38(6.42 to 12.34)
OG00112.07(9.48 to 14.67)
OG00211.22(7.65 to 14.79)
Week 48
Title
Measurements
OG0009.53(6.51 to 12.55)
OG00110.99(8.33 to 13.64)
OG00210.22(6.57 to 13.86)
Week 52
Title
Measurements
OG00010.08(7.05 to 13.12)
OG00111.42(8.75 to 14.09)
OG0029.59(5.93 to 13.25)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 40: Faricimab Q12W vs. Ranibizumab Q4W
Mean Difference (Net)
-2.09
2-Sided
80
-6.75
2.56
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 40: Faricimab Q16W vs. Ranibizumab Q4W
Mean Difference (Net)
1.05
2-Sided
80
-3.40
5.49
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG000
OG002
Week 52: Faricimab Q12W vs. Ranibizumab Q4W
Mean Difference (Net)
0.49
2-Sided
80
-4.26
5.25
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 52: Faricimab Q16W vs. Ranibizumab Q4W
Mean Difference (Net)
1.83
2-Sided
80
-2.71
6.37
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Day 7: Gaining ≥15 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG0001
OG0012
OG0021
Day 7: Gaining ≥10 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Day 7: Gaining ≥5 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Day 7: Gaining ≥0 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4: Gaining ≥15 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4: Gaining ≥10 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4: Gaining ≥5 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4: Gaining ≥0 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8: Gaining ≥15 Letters
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 8: Gaining ≥10 Letters
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 8: Gaining ≥5 Letters
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 8: Gaining ≥0 Letters
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12: Gaining ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 12: Gaining ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 12: Gaining ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 12: Gaining ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16: Gaining ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16: Gaining ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16: Gaining ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16: Gaining ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20: Gaining ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20: Gaining ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20: Gaining ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20: Gaining ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24: Gaining ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24: Gaining ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24: Gaining ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24: Gaining ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28: Gaining ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28: Gaining ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28: Gaining ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28: Gaining ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32: Gaining ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32: Gaining ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32: Gaining ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32: Gaining ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36: Gaining ≥15 Letters
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 36: Gaining ≥10 Letters
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 36: Gaining ≥5 Letters
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 36: Gaining ≥0 Letters
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40: Gaining ≥15 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 40: Gaining ≥10 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 40: Gaining ≥5 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 40: Gaining ≥0 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44: Gaining ≥15 Letters
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 44: Gaining ≥10 Letters
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 44: Gaining ≥5 Letters
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 44: Gaining ≥0 Letters
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48: Gaining ≥15 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 48: Gaining ≥10 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 48: Gaining ≥5 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 48: Gaining ≥0 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52: Gaining ≥15 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52: Gaining ≥10 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52: Gaining ≥5 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52: Gaining ≥0 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Day 7
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG0004.2(0.00 to 9.39)
OG0016.5(0.80 to 12.11)
OG0026.3(0.00 to 14.01)
Week 4
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 40: Faricimab Q12W vs. Ranibizumab Q4W
Difference in Percentage of Participants
4.76
2-Sided
80
-15.92
25.44
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 40: Faricimab Q16W vs. Ranibizumab Q4W
Difference in Percentage of Participants
5.95
2-Sided
80
-13.62
25.53
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG000
OG002
Week 52: Faricimab Q12W vs. Ranibizumab Q4W
Difference in Percentage of Participants
-4.17
2-Sided
80
-24.52
16.19
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 52: Faricimab Q16W vs. Ranibizumab Q4W
Difference in Percentage of Participants
8.93
2-Sided
80
-10.73
28.59
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Day 7: Not Losing ≥15 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG00024
OG00131
OG00216
Day 7: Not Losing ≥10 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Day 7: Not Losing ≥5 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Day 7: Not Losing ≥0 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4: Not Losing ≥15 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4: Not Losing ≥10 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4: Not Losing ≥5 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4: Not Losing ≥0 Letters
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8: Not Losing ≥15 Letters
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 8: Not Losing ≥10 Letters
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 8: Not Losing ≥5 Letters
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 8: Not Losing ≥0 Letters
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12: Not Losing ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 12: Not Losing ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 12: Not Losing ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 12: Not Losing ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16: Not Losing ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16: Not Losing ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16: Not Losing ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16: Not Losing ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20: Not Losing ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20: Not Losing ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20: Not Losing ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20: Not Losing ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24: Not Losing ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24: Not Losing ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24: Not Losing ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24: Not Losing ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28: Not Losing ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28: Not Losing ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28: Not Losing ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28: Not Losing ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32: Not Losing ≥15 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32: Not Losing ≥10 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32: Not Losing ≥5 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32: Not Losing ≥0 Letters
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36: Not Losing ≥15 Letters
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 36: Not Losing ≥10 Letters
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 36: Not Losing ≥5 Letters
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 36: Not Losing ≥0 Letters
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40: Not Losing ≥15 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 40: Not Losing ≥10 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 40: Not Losing ≥5 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 40: Not Losing ≥0 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44: Not Losing ≥15 Letters
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 44: Not Losing ≥10 Letters
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 44: Not Losing ≥5 Letters
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 44: Not Losing ≥0 Letters
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48: Not Losing ≥15 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 48: Not Losing ≥10 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 48: Not Losing ≥5 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 48: Not Losing ≥0 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52: Not Losing ≥15 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52: Not Losing ≥10 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52: Not Losing ≥5 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52: Not Losing ≥0 Letters
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Day 7
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000100.0(100.00 to 100.00)
OG001100.0(100.00 to 100.00)
OG002100.0(100.00 to 100.00)
Week 4
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 40: Faricimab Q12W vs. Ranibizumab Q4W
Difference in Percentage of Participants
-4.76
2-Sided
80
-10.72
1.19
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 40: Faricimab Q16W vs. Ranibizumab Q4W
Difference in Percentage of Participants
-3.57
2-Sided
80
-8.07
0.92
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG000
OG002
Week 52: Faricimab Q12W vs. Ranibizumab Q4W
Difference in Percentage of Participants
0
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 52: Faricimab Q16W vs. Ranibizumab Q4W
Difference in Percentage of Participants
-3.57
2-Sided
80
-8.07
0.92
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Baseline
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG00012.5(3.85 to 21.15)
OG00122.6(12.96 to 32.20)
OG00218.8(6.24 to 31.26)
Day 7
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 40: Faricimab Q12W vs. Ranibizumab Q4W
Difference in Percentage of Participants
21.90
2-Sided
80
0.76
43.05
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 40: Faricimab Q16W vs. Ranibizumab Q4W
Difference in Percentage of Participants
38.57
2-Sided
80
19.56
57.59
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG000
OG002
Week 52: Faricimab Q12W vs. Ranibizumab Q4W
Difference in Percentage of Participants
19.64
2-Sided
80
-1.14
40.43
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 52: Faricimab Q16W vs. Ranibizumab Q4W
Difference in Percentage of Participants
33.93
2-Sided
80
14.95
52.91
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Baseline
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG0008.3(1.10 to 15.56)
OG0013.2(0.00 to 7.29)
OG00212.5(1.90 to 23.10)
Day 7
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 40: Faricimab Q12W vs. Ranibizumab Q4W
Difference in Percentage of Participants
0
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 40: Faricimab Q16W vs. Ranibizumab Q4W
Difference in Percentage of Participants
3.57
2-Sided
80
-0.92
8.07
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG000
OG002
Week 52: Faricimab Q12W vs. Ranibizumab Q4W
Difference in Percentage of Participants
4.76
2-Sided
80
-1.19
10.72
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 52: Faricimab Q16W vs. Ranibizumab Q4W
Difference in Percentage of Participants
3.57
2-Sided
80
-0.92
8.07
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Day 7
Title
Measurements
OG000-93.56(-109.05 to -78.07)
OG001-94.31(-107.78 to -80.83)
OG002-76.01(-95.07 to -56.95)
Week 4
Title
Measurements
OG000-132.27(-146.13 to -118.41)
OG001-130.11(-142.37 to -117.85)
OG002-122.07(-139.47 to -104.67)
Week 8
Title
Measurements
OG000-134.47(-148.30 to -120.65)
OG001-136.15(-148.42 to -123.89)
OG002-127.64(-145.03 to -110.24)
Week 12
Title
Measurements
OG000-142.26(-157.01 to -127.52)
OG001-139.63(-152.66 to -126.59)
OG002-126.63(-145.03 to -108.24)
Week 16
Title
Measurements
OG000-134.94(-150.26 to -119.63)
OG001-137.81(-151.37 to -124.25)
OG002-120.48(-139.55 to -101.40)
Week 20
Title
Measurements
OG000-125.05(-143.75 to -106.35)
OG001-125.35(-141.86 to -108.84)
OG002-120.70(-143.69 to -97.70)
Week 24
Title
Measurements
OG000-121.13(-140.94 to -101.31)
OG001-108.66(-126.14 to -91.17)
OG002-131.29(-155.62 to -106.96)
Week 28
Title
Measurements
OG000-131.58(-148.18 to -114.99)
OG001-116.76(-131.41 to -102.12)
OG002-130.29(-150.80 to -109.78)
Week 32
Title
Measurements
OG000-127.85(-149.31 to -106.38)
OG001-123.44(-142.37 to -104.51)
OG002-134.29(-160.61 to -107.97)
Week 36
Title
Measurements
OG000-114.27(-134.82 to -93.71)
OG001-114.97(-133.02 to -96.92)
OG002-149.26(-174.17 to -124.35)
Week 40
Title
Measurements
OG000-137.54(-156.68 to -118.40)
OG001-123.31(-140.20 to -106.42)
OG002-137.99(-161.27 to -114.71)
Week 44
Title
Measurements
OG000-135.30(-154.78 to -115.82)
OG001-110.26(-127.23 to -93.30)
OG002-135.70(-159.16 to -112.23)
Week 48
Title
Measurements
OG000-125.93(-145.69 to -106.17)
OG001-121.67(-139.07 to -104.26)
OG002-130.76(-154.93 to -106.58)
Week 52
Title
Measurements
OG000-140.95(-157.06 to -124.85)
OG001-134.99(-149.21 to -120.76)
OG002-136.10(-155.98 to -116.23)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 40: Faricimab Q12W vs. Ranibizumab Q4W
Mean Difference (Net)
0.45
2-Sided
80
-29.81
30.71
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 40: Faricimab Q16W vs. Ranibizumab Q4W
Mean Difference (Net)
14.68
2-Sided
80
-14.29
43.65
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG000
OG002
Week 52: Faricimab Q12W vs. Ranibizumab Q4W
Mean Difference (Net)
-4.85
2-Sided
80
-30.57
20.87
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 52: Faricimab Q16W vs. Ranibizumab Q4W
Mean Difference (Net)
1.12
2-Sided
80
-23.57
25.80
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Day 7
Title
Measurements
OG000-88.87(-100.40 to -77.34)
OG001-84.23(-94.35 to -74.11)
OG002-80.08(-94.15 to -66.01)
Week 4
Title
Measurements
OG000-127.20(-139.69 to -114.72)
OG001-123.10(-134.18 to -112.02)
OG002-111.58(-126.99 to -96.17)
Week 8
Title
Measurements
OG000-132.03(-145.40 to -118.67)
OG001-131.25(-143.13 to -119.37)
OG002-117.04(-133.54 to -100.53)
Week 12
Title
Measurements
OG000-134.70(-148.96 to -120.44)
OG001-132.87(-145.53 to -120.20)
OG002-122.39(-139.93 to -104.85)
Week 16
Title
Measurements
OG000-132.96(-147.69 to -118.23)
OG001-132.50(-145.58 to -119.42)
OG002-122.70(-140.81 to -104.60)
Week 20
Title
Measurements
OG000-114.97(-131.83 to -98.12)
OG001-118.89(-133.77 to -104.00)
OG002-120.77(-141.28 to -100.25)
Week 24
Title
Measurements
OG000-101.62(-119.69 to -83.54)
OG001-99.35(-115.29 to -83.42)
OG002-121.33(-143.26 to -99.40)
Week 28
Title
Measurements
OG000-129.68(-144.40 to -114.95)
OG001-109.89(-122.91 to -96.87)
OG002-127.95(-145.93 to -109.98)
Week 32
Title
Measurements
OG000-121.10(-139.50 to -102.71)
OG001-116.35(-132.57 to -100.14)
OG002-127.20(-149.56 to -104.85)
Week 36
Title
Measurements
OG000-101.98(-121.60 to -82.36)
OG001-102.69(-119.96 to -85.42)
OG002-118.89(-142.63 to -95.15)
Week 40
Title
Measurements
OG000-138.55(-154.04 to -123.05)
OG001-121.34(-135.07 to -107.62)
OG002-126.32(-145.20 to -107.44)
Week 44
Title
Measurements
OG000-130.50(-146.19 to -114.81)
OG001-103.31(-117.04 to -89.57)
OG002-124.89(-143.71 to -106.08)
Week 48
Title
Measurements
OG000-126.45(-145.58 to -107.33)
OG001-102.30(-119.14 to -85.47)
OG002-123.89(-147.01 to -100.77)
Week 52
Title
Measurements
OG000-138.53(-152.42 to -124.65)
OG001-122.53(-134.81 to -110.25)
OG002-129.89(-146.74 to -113.04)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 40: Faricimab Q12W vs. Ranibizumab Q4W
Mean Difference (Net)
-12.23
2-Sided
80
-36.60
12.15
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 40: Faricimab Q16W vs. Ranibizumab Q4W
Mean Difference (Net)
4.98
2-Sided
80
-18.50
28.45
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG000
OG002
Week 52: Faricimab Q12W vs. Ranibizumab Q4W
Mean Difference (Net)
-8.64
2-Sided
80
-30.42
13.14
The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG001
OG002
Week 52: Faricimab Q16W vs. Ranibizumab Q4W
Mean Difference (Net)
7.36
2-Sided
80
-13.65
28.37
The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
Other
The focus of this trial was estimation rather than hypothesis testing.
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Baseline
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG0004.2(0.00 to 9.39)
OG00129.0(18.58 to 39.48)
OG00218.8(6.24 to 31.26)
Day 7
ParticipantsOG00023
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Baseline
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG00020.8(10.21 to 31.46)
OG00112.9(5.19 to 20.62)
OG00225.0(11.13 to 38.87)
Day 7
ParticipantsOG00023
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Baseline
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG00033.3(21.00 to 45.67)
OG00148.4(36.88 to 59.89)
OG00237.5(21.99 to 53.01)
Day 7
ParticipantsOG00023
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Baseline
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG0008.3(1.10 to 15.56)
OG00129.0(18.58 to 39.48)
OG00212.5(1.90 to 23.10)
Day 7
ParticipantsOG00023
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 4
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG000
Week 8
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00215
Title
Measurements
OG000
Week 12
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 16
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 20
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 24
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 28
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 32
ParticipantsOG00023
ParticipantsOG00130
ParticipantsOG00216
Title
Measurements
OG000
Week 36
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 40
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00215
Title
Measurements
OG000
Week 44
ParticipantsOG00020
ParticipantsOG00129
ParticipantsOG00216
Title
Measurements
OG000
Week 48
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Week 52
ParticipantsOG00021
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Baseline (BL): Absolute Value
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG0007.1± 3.9
OG0015.9± 3.8
OG0027.3± 2.9
Change from BL at Week 40
ParticipantsOG00019
ParticipantsOG00126
ParticipantsOG00214
Title
Measurements
OG000
Change from BL at Week 52
ParticipantsOG00019
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Baseline (BL): Absolute Value
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG0007.0± 3.8
OG0015.8± 3.6
OG0027.1± 3.0
Change from BL at Week 40
ParticipantsOG00019
ParticipantsOG00126
ParticipantsOG00214
Title
Measurements
OG000
Change from BL at Week 52
ParticipantsOG00019
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
Units
Counts
Participants
OG00024
OG00131
OG00216
Title
Denominators
Categories
Baseline (BL): Absolute Value
ParticipantsOG00024
ParticipantsOG00131
ParticipantsOG00216
Title
Measurements
OG0007.0± 3.8
OG0016.1± 3.4
OG0027.6± 2.9
Change from BL at Week 40
ParticipantsOG00019
ParticipantsOG00126
ParticipantsOG00214
Title
Measurements
OG000
Change from BL at Week 52
ParticipantsOG00019
ParticipantsOG00128
ParticipantsOG00216
Title
Measurements
OG000
Units
Counts
Participants
OG00024
OG00131
Title
Denominators
Categories
ADA Negative to ADA Negative
Title
Measurements
OG00021
OG00125
ADA Negative to ADA Positive
Title
Measurements
OG0001
OG0014
Missing to ADA Negative
Title
Measurements
OG0000
OG0011
Missing to ADA Positive
Title
Measurements
OG0001
OG0010
No Post-Baseline ADA Assessment
Title
Measurements
OG0001
OG0011
OG002
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).