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STAIRWAY: Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT03038880
Collaborator
(none)
76
Enrollment
25
Locations
3
Arms
14
Actual Duration (Months)
3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 27, 2017
Actual Primary Completion Date :
Jan 11, 2018
Actual Study Completion Date :
Mar 29, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: Faricimab
Faricimab was administered via IVT injections as specified during the treatment period.
Other Names:
  • RO6867461
  • RG7716

    • Drug: Sham Procedure
    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.
    Experimental: 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.

    Drug: Faricimab
    Faricimab was administered via IVT injections as specified during the treatment period.
    Other Names:
  • RO6867461
  • RG7716

    • Drug: Sham Procedure
    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.
    Active Comparator: 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).

    Drug: Ranibizumab
    Ranibizumab was administered via IVT injections as specified during the treatment period.
    Other Names:
  • Lucentis®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 40, Using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA Charts [Baseline, Week 40]

      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.

    Secondary Outcome Measures

    1. Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    2. Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    3. Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    4. Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    5. Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    6. Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    7. Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    8. Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    9. Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    10. Percentage of Participants With No Intraretinal Fluid at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    11. Percentage of Participants With No Subretinal Fluid at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    12. Percentage of Participants With No Cysts at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    13. Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints [Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52]

      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.

    14. Mean Baseline Value and Mean Change From Baseline of Total Area of Choroidal Neovascularization (CNV) at Week 40 and Week 52 [Baseline, Week 40, Week 52]

      The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA).

    15. Mean Baseline Value and Mean Change From Baseline of Total Area of CNV Component at Week 40 and Week 52 [Baseline, Week 40, 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).

    16. Mean Baseline Value and Mean Change From Baseline of Total Area of Leakage at Week 40 and Week 52 [Baseline, Week 40, Week 52]

      The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA).

    17. Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline [Predose at Baseline (Day 1), Weeks 16, 24, 28, 44, and 52]

      Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to faricimab by a validated enzyme-linked immunosorbent assay (ELISA).

    18. Safety Summary: Number and Percentage of Participants With at Least One Adverse Event [From Baseline until 28 days after the last dose of study drug (up to 52 weeks)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants of Arizona Phoenix Arizona United States 85053
    2 Retina Associates Southwest PC Tucson Arizona United States 85704
    3 California Retina Consultants Bakersfield California United States 93309
    4 Retinal Diagnostic Center Campbell California United States 95008
    5 Retina Consultants of Southern Colorado PC; Clinical Research Department Colorado Springs Colorado United States 80909-1183
    6 Rand Eye Deerfield Beach Florida United States 33064
    7 Florida Eye Associates Melbourne Florida United States 32901
    8 Retina Vitreous Assoc of FL Saint Petersburg Florida United States 33711
    9 Southern Vitreoretinal Assoc Tallahassee Florida United States 32308
    10 Southeast Retina Center Augusta Georgia United States 30909
    11 Midwest Eye Institute Indianapolis Indiana United States 46290
    12 Wolfe Eye Clinic West Des Moines Iowa United States 50266
    13 The Retina Care Center Baltimore Maryland United States 21209
    14 Vitreo Retinal Surgery Minneapolis Minnesota United States 55435
    15 Sierra Eye Associates Reno Nevada United States 89502
    16 Eye Associates of New Mexico Albuquerque New Mexico United States 87109
    17 Vitreoretinal Consultants Great Neck New York United States 11021
    18 Oregon Retina, LLP Eugene Oregon United States 97401
    19 Retina Northwest Portland Oregon United States 97221
    20 Charles Retina Institute Germantown Tennessee United States 38138
    21 Retina Res Institute of Texas Abilene Texas United States 79606
    22 Texas Retina Associates Arlington Texas United States 76012
    23 Retina Research Center Austin Texas United States 78750
    24 Strategic Clinical Research Group, LLC Willow Park Texas United States 76087
    25 Retina Associates of Utah Salt Lake City Utah United States 84107

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03038880
    Other Study ID Numbers:
    • CR39521
    First Posted:
    Feb 1, 2017
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Degeneration
    Choroidal Neovascularization
    Neovascularization, Pathologic
    Ranibizumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Period Title: Overall Study
    STARTED 24 31 16
    COMPLETED 21 28 16
    NOT COMPLETED 3 3 0

    Baseline Characteristics

    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W Total
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections). Total of all reporting groups
    Overall Participants 24 31 16 71
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    80.3
    (7.23)
    77.7
    (8.38)
    77.3
    (10.29)
    78.5
    (8.47)
    Sex: Female, Male (Count of Participants)
    Female
    13
    54.2%
    18
    58.1%
    10
    62.5%
    41
    57.7%
    Male
    11
    45.8%
    13
    41.9%
    6
    37.5%
    30
    42.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    4.2%
    0
    0%
    0
    0%
    1
    1.4%
    Not Hispanic or Latino
    23
    95.8%
    31
    100%
    16
    100%
    70
    98.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    0
    0%
    1
    3.2%
    0
    0%
    1
    1.4%
    Black or African American
    1
    4.2%
    0
    0%
    0
    0%
    1
    1.4%
    White
    23
    95.8%
    30
    96.8%
    16
    100%
    69
    97.2%
    Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Baseline (ETDRS Letters) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [ETDRS Letters]
    57.8
    (10.46)
    60.4
    (10.80)
    55.3
    (12.08)
    58.4
    (11.02)
    Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline (Count of Participants)
    Classic and Occult CNV
    0
    0%
    2
    6.5%
    2
    12.5%
    4
    5.6%
    Classic CNV
    9
    37.5%
    9
    29%
    6
    37.5%
    24
    33.8%
    Occult CNV
    15
    62.5%
    20
    64.5%
    8
    50%
    43
    60.6%
    Central Foveal Thickness in the Study Eye at Baseline (microns (μm)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [microns (μm)]
    290.8
    (118.61)
    280.8
    (98.95)
    375.6
    (159.41)
    305.6
    (125.42)
    Central Subfield Thickness in the Study Eye at Baseline (microns (μm)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [microns (μm)]
    417.9
    (84.28)
    382.2
    (80.87)
    443.1
    (125.00)
    408.0
    (95.36)

    Outcome Measures

    1. Primary Outcome
    Title Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 40, Using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA Charts
    Description 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.
    Time Frame Baseline, Week 40

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Least Squares Mean (80% Confidence Interval) [ETDRS Letters]
    9.3
    12.5
    11.4
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.1
    Confidence Interval (2-Sided) 80%
    -6.8 to 2.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.1
    Confidence Interval (2-Sided) 80%
    -3.4 to 5.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    2. Secondary Outcome
    Title Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Day 7
    3.78
    4.62
    3.53
    Week 4
    5.99
    7.55
    7.53
    Week 8
    5.28
    9.15
    10.55
    Week 12
    7.31
    10.19
    9.91
    Week 16
    8.31
    11.62
    10.78
    Week 20
    8.02
    10.40
    11.53
    Week 24
    8.11
    10.37
    10.97
    Week 28
    9.59
    11.82
    12.16
    Week 32
    9.87
    12.44
    11.91
    Week 36
    9.01
    12.38
    12.03
    Week 40
    9.33
    12.47
    11.42
    Week 44
    9.38
    12.07
    11.22
    Week 48
    9.53
    10.99
    10.22
    Week 52
    10.08
    11.42
    9.59
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.09
    Confidence Interval (2-Sided) 80%
    -6.75 to 2.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.05
    Confidence Interval (2-Sided) 80%
    -3.40 to 5.49
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.49
    Confidence Interval (2-Sided) 80%
    -4.26 to 5.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.83
    Confidence Interval (2-Sided) 80%
    -2.71 to 6.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    3. Secondary Outcome
    Title Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Day 7: Gaining ≥15 Letters
    1
    4.2%
    2
    6.5%
    1
    6.3%
    Day 7: Gaining ≥10 Letters
    2
    8.3%
    4
    12.9%
    1
    6.3%
    Day 7: Gaining ≥5 Letters
    11
    45.8%
    16
    51.6%
    6
    37.5%
    Day 7: Gaining ≥0 Letters
    20
    83.3%
    26
    83.9%
    15
    93.8%
    Week 4: Gaining ≥15 Letters
    3
    12.5%
    4
    12.9%
    3
    18.8%
    Week 4: Gaining ≥10 Letters
    5
    20.8%
    8
    25.8%
    5
    31.3%
    Week 4: Gaining ≥5 Letters
    15
    62.5%
    19
    61.3%
    8
    50%
    Week 4: Gaining ≥0 Letters
    20
    83.3%
    30
    96.8%
    15
    93.8%
    Week 8: Gaining ≥15 Letters
    3
    12.5%
    5
    16.1%
    6
    37.5%
    Week 8: Gaining ≥10 Letters
    7
    29.2%
    10
    32.3%
    8
    50%
    Week 8: Gaining ≥5 Letters
    14
    58.3%
    26
    83.9%
    10
    62.5%
    Week 8: Gaining ≥0 Letters
    21
    87.5%
    28
    90.3%
    15
    93.8%
    Week 12: Gaining ≥15 Letters
    2
    8.3%
    7
    22.6%
    3
    18.8%
    Week 12: Gaining ≥10 Letters
    8
    33.3%
    16
    51.6%
    7
    43.8%
    Week 12: Gaining ≥5 Letters
    15
    62.5%
    23
    74.2%
    11
    68.8%
    Week 12: Gaining ≥0 Letters
    19
    79.2%
    29
    93.5%
    15
    93.8%
    Week 16: Gaining ≥15 Letters
    4
    16.7%
    9
    29%
    3
    18.8%
    Week 16: Gaining ≥10 Letters
    10
    41.7%
    16
    51.6%
    8
    50%
    Week 16: Gaining ≥5 Letters
    16
    66.7%
    27
    87.1%
    13
    81.3%
    Week 16: Gaining ≥0 Letters
    21
    87.5%
    29
    93.5%
    16
    100%
    Week 20: Gaining ≥15 Letters
    4
    16.7%
    10
    32.3%
    3
    18.8%
    Week 20: Gaining ≥10 Letters
    10
    41.7%
    17
    54.8%
    9
    56.3%
    Week 20: Gaining ≥5 Letters
    16
    66.7%
    22
    71%
    14
    87.5%
    Week 20: Gaining ≥0 Letters
    20
    83.3%
    26
    83.9%
    16
    100%
    Week 24: Gaining ≥15 Letters
    4
    16.7%
    8
    25.8%
    4
    25%
    Week 24: Gaining ≥10 Letters
    9
    37.5%
    16
    51.6%
    9
    56.3%
    Week 24: Gaining ≥5 Letters
    15
    62.5%
    22
    71%
    12
    75%
    Week 24: Gaining ≥0 Letters
    19
    79.2%
    27
    87.1%
    15
    93.8%
    Week 28: Gaining ≥15 Letters
    6
    25%
    12
    38.7%
    5
    31.3%
    Week 28: Gaining ≥10 Letters
    13
    54.2%
    15
    48.4%
    9
    56.3%
    Week 28: Gaining ≥5 Letters
    16
    66.7%
    24
    77.4%
    11
    68.8%
    Week 28: Gaining ≥0 Letters
    21
    87.5%
    27
    87.1%
    16
    100%
    Week 32: Gaining ≥15 Letters
    7
    29.2%
    11
    35.5%
    6
    37.5%
    Week 32: Gaining ≥10 Letters
    11
    45.8%
    18
    58.1%
    9
    56.3%
    Week 32: Gaining ≥5 Letters
    17
    70.8%
    27
    87.1%
    11
    68.8%
    Week 32: Gaining ≥0 Letters
    22
    91.7%
    28
    90.3%
    15
    93.8%
    Week 36: Gaining ≥15 Letters
    7
    29.2%
    11
    35.5%
    6
    37.5%
    Week 36: Gaining ≥10 Letters
    10
    41.7%
    20
    64.5%
    10
    62.5%
    Week 36: Gaining ≥5 Letters
    15
    62.5%
    24
    77.4%
    12
    75%
    Week 36: Gaining ≥0 Letters
    19
    79.2%
    25
    80.6%
    15
    93.8%
    Week 40: Gaining ≥15 Letters
    8
    33.3%
    11
    35.5%
    5
    31.3%
    Week 40: Gaining ≥10 Letters
    11
    45.8%
    18
    58.1%
    8
    50%
    Week 40: Gaining ≥5 Letters
    15
    62.5%
    24
    77.4%
    10
    62.5%
    Week 40: Gaining ≥0 Letters
    17
    70.8%
    27
    87.1%
    13
    81.3%
    Week 44: Gaining ≥15 Letters
    7
    29.2%
    13
    41.9%
    6
    37.5%
    Week 44: Gaining ≥10 Letters
    12
    50%
    15
    48.4%
    9
    56.3%
    Week 44: Gaining ≥5 Letters
    13
    54.2%
    26
    83.9%
    11
    68.8%
    Week 44: Gaining ≥0 Letters
    15
    62.5%
    27
    87.1%
    13
    81.3%
    Week 48: Gaining ≥15 Letters
    7
    29.2%
    10
    32.3%
    6
    37.5%
    Week 48: Gaining ≥10 Letters
    12
    50%
    17
    54.8%
    10
    62.5%
    Week 48: Gaining ≥5 Letters
    15
    62.5%
    20
    64.5%
    11
    68.8%
    Week 48: Gaining ≥0 Letters
    18
    75%
    26
    83.9%
    12
    75%
    Week 52: Gaining ≥15 Letters
    7
    29.2%
    13
    41.9%
    6
    37.5%
    Week 52: Gaining ≥10 Letters
    11
    45.8%
    17
    54.8%
    9
    56.3%
    Week 52: Gaining ≥5 Letters
    14
    58.3%
    23
    74.2%
    9
    56.3%
    Week 52: Gaining ≥0 Letters
    17
    70.8%
    26
    83.9%
    13
    81.3%
    4. Secondary Outcome
    Title Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Day 7
    4.2
    17.5%
    6.5
    21%
    6.3
    39.4%
    Week 4
    12.5
    52.1%
    12.9
    41.6%
    18.8
    117.5%
    Week 8
    12.5
    52.1%
    16.7
    53.9%
    40.0
    250%
    Week 12
    8.7
    36.3%
    23.3
    75.2%
    18.8
    117.5%
    Week 16
    17.4
    72.5%
    30.0
    96.8%
    18.8
    117.5%
    Week 20
    17.4
    72.5%
    33.3
    107.4%
    18.8
    117.5%
    Week 24
    17.4
    72.5%
    26.7
    86.1%
    25.0
    156.3%
    Week 28
    26.1
    108.8%
    40.0
    129%
    31.3
    195.6%
    Week 32
    30.4
    126.7%
    36.7
    118.4%
    37.5
    234.4%
    Week 36
    31.8
    132.5%
    37.9
    122.3%
    37.5
    234.4%
    Week 40
    38.1
    158.8%
    39.3
    126.8%
    33.3
    208.1%
    Week 44
    35.0
    145.8%
    44.8
    144.5%
    37.5
    234.4%
    Week 48
    33.3
    138.8%
    35.7
    115.2%
    37.5
    234.4%
    Week 52
    33.3
    138.8%
    46.4
    149.7%
    37.5
    234.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 4.76
    Confidence Interval (2-Sided) 80%
    -15.92 to 25.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 5.95
    Confidence Interval (2-Sided) 80%
    -13.62 to 25.53
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value -4.17
    Confidence Interval (2-Sided) 80%
    -24.52 to 16.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 8.93
    Confidence Interval (2-Sided) 80%
    -10.73 to 28.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    5. Secondary Outcome
    Title Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Day 7: Not Losing ≥15 Letters
    24
    100%
    31
    100%
    16
    100%
    Day 7: Not Losing ≥10 Letters
    24
    100%
    31
    100%
    16
    100%
    Day 7: Not Losing ≥5 Letters
    21
    87.5%
    29
    93.5%
    15
    93.8%
    Day 7: Not Losing ≥0 Letters
    18
    75%
    24
    77.4%
    10
    62.5%
    Week 4: Not Losing ≥15 Letters
    24
    100%
    31
    100%
    16
    100%
    Week 4: Not Losing ≥10 Letters
    24
    100%
    31
    100%
    16
    100%
    Week 4: Not Losing ≥5 Letters
    23
    95.8%
    31
    100%
    16
    100%
    Week 4: Not Losing ≥0 Letters
    18
    75%
    29
    93.5%
    13
    81.3%
    Week 8: Not Losing ≥15 Letters
    23
    95.8%
    30
    96.8%
    15
    93.8%
    Week 8: Not Losing ≥10 Letters
    23
    95.8%
    30
    96.8%
    15
    93.8%
    Week 8: Not Losing ≥5 Letters
    22
    91.7%
    29
    93.5%
    15
    93.8%
    Week 8: Not Losing ≥0 Letters
    20
    83.3%
    28
    90.3%
    13
    81.3%
    Week 12: Not Losing ≥15 Letters
    23
    95.8%
    29
    93.5%
    16
    100%
    Week 12: Not Losing ≥10 Letters
    23
    95.8%
    29
    93.5%
    16
    100%
    Week 12: Not Losing ≥5 Letters
    23
    95.8%
    29
    93.5%
    16
    100%
    Week 12: Not Losing ≥0 Letters
    19
    79.2%
    28
    90.3%
    14
    87.5%
    Week 16: Not Losing ≥15 Letters
    23
    95.8%
    29
    93.5%
    16
    100%
    Week 16: Not Losing ≥10 Letters
    23
    95.8%
    29
    93.5%
    16
    100%
    Week 16: Not Losing ≥5 Letters
    22
    91.7%
    29
    93.5%
    16
    100%
    Week 16: Not Losing ≥0 Letters
    19
    79.2%
    29
    93.5%
    16
    100%
    Week 20: Not Losing ≥15 Letters
    23
    95.8%
    29
    93.5%
    16
    100%
    Week 20: Not Losing ≥10 Letters
    23
    95.8%
    29
    93.5%
    16
    100%
    Week 20: Not Losing ≥5 Letters
    22
    91.7%
    29
    93.5%
    16
    100%
    Week 20: Not Losing ≥0 Letters
    19
    79.2%
    24
    77.4%
    14
    87.5%
    Week 24: Not Losing ≥15 Letters
    23
    95.8%
    30
    96.8%
    16
    100%
    Week 24: Not Losing ≥10 Letters
    22
    91.7%
    29
    93.5%
    16
    100%
    Week 24: Not Losing ≥5 Letters
    22
    91.7%
    28
    90.3%
    16
    100%
    Week 24: Not Losing ≥0 Letters
    19
    79.2%
    27
    87.1%
    14
    87.5%
    Week 28: Not Losing ≥15 Letters
    23
    95.8%
    29
    93.5%
    16
    100%
    Week 28: Not Losing ≥10 Letters
    23
    95.8%
    28
    90.3%
    16
    100%
    Week 28: Not Losing ≥5 Letters
    21
    87.5%
    28
    90.3%
    16
    100%
    Week 28: Not Losing ≥0 Letters
    20
    83.3%
    27
    87.1%
    16
    100%
    Week 32: Not Losing ≥15 Letters
    23
    95.8%
    29
    93.5%
    16
    100%
    Week 32: Not Losing ≥10 Letters
    23
    95.8%
    28
    90.3%
    16
    100%
    Week 32: Not Losing ≥5 Letters
    22
    91.7%
    28
    90.3%
    16
    100%
    Week 32: Not Losing ≥0 Letters
    20
    83.3%
    28
    90.3%
    13
    81.3%
    Week 36: Not Losing ≥15 Letters
    21
    87.5%
    28
    90.3%
    16
    100%
    Week 36: Not Losing ≥10 Letters
    21
    87.5%
    28
    90.3%
    16
    100%
    Week 36: Not Losing ≥5 Letters
    20
    83.3%
    27
    87.1%
    15
    93.8%
    Week 36: Not Losing ≥0 Letters
    19
    79.2%
    25
    80.6%
    14
    87.5%
    Week 40: Not Losing ≥15 Letters
    20
    83.3%
    27
    87.1%
    15
    93.8%
    Week 40: Not Losing ≥10 Letters
    20
    83.3%
    27
    87.1%
    15
    93.8%
    Week 40: Not Losing ≥5 Letters
    19
    79.2%
    27
    87.1%
    15
    93.8%
    Week 40: Not Losing ≥0 Letters
    17
    70.8%
    25
    80.6%
    12
    75%
    Week 44: Not Losing ≥15 Letters
    20
    83.3%
    28
    90.3%
    16
    100%
    Week 44: Not Losing ≥10 Letters
    20
    83.3%
    28
    90.3%
    16
    100%
    Week 44: Not Losing ≥5 Letters
    17
    70.8%
    28
    90.3%
    16
    100%
    Week 44: Not Losing ≥0 Letters
    14
    58.3%
    27
    87.1%
    12
    75%
    Week 48: Not Losing ≥15 Letters
    21
    87.5%
    27
    87.1%
    16
    100%
    Week 48: Not Losing ≥10 Letters
    20
    83.3%
    27
    87.1%
    16
    100%
    Week 48: Not Losing ≥5 Letters
    19
    79.2%
    27
    87.1%
    15
    93.8%
    Week 48: Not Losing ≥0 Letters
    16
    66.7%
    25
    80.6%
    11
    68.8%
    Week 52: Not Losing ≥15 Letters
    21
    87.5%
    27
    87.1%
    16
    100%
    Week 52: Not Losing ≥10 Letters
    21
    87.5%
    27
    87.1%
    16
    100%
    Week 52: Not Losing ≥5 Letters
    20
    83.3%
    27
    87.1%
    15
    93.8%
    Week 52: Not Losing ≥0 Letters
    16
    66.7%
    26
    83.9%
    11
    68.8%
    6. Secondary Outcome
    Title Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Day 7
    100.0
    416.7%
    100.0
    322.6%
    100.0
    625%
    Week 4
    100.0
    416.7%
    100.0
    322.6%
    100.0
    625%
    Week 8
    95.8
    399.2%
    100.0
    322.6%
    100.0
    625%
    Week 12
    100.0
    416.7%
    96.7
    311.9%
    100.0
    625%
    Week 16
    100.0
    416.7%
    96.7
    311.9%
    100.0
    625%
    Week 20
    100.0
    416.7%
    96.7
    311.9%
    100.0
    625%
    Week 24
    100.0
    416.7%
    100.0
    322.6%
    100.0
    625%
    Week 28
    100.0
    416.7%
    96.7
    311.9%
    100.0
    625%
    Week 32
    100.0
    416.7%
    96.7
    311.9%
    100.0
    625%
    Week 36
    95.5
    397.9%
    96.6
    311.6%
    100.0
    625%
    Week 40
    95.2
    396.7%
    96.4
    311%
    100.0
    625%
    Week 44
    100.0
    416.7%
    96.6
    311.6%
    100.0
    625%
    Week 48
    100.0
    416.7%
    96.4
    311%
    100.0
    625%
    Week 52
    100.0
    416.7%
    96.4
    311%
    100.0
    625%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value -4.76
    Confidence Interval (2-Sided) 80%
    -10.72 to 1.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value -3.57
    Confidence Interval (2-Sided) 80%
    -8.07 to 0.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 0
    Confidence Interval () %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value -3.57
    Confidence Interval (2-Sided) 80%
    -8.07 to 0.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    7. Secondary Outcome
    Title Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Baseline
    12.5
    52.1%
    22.6
    72.9%
    18.8
    117.5%
    Day 7
    20.8
    86.7%
    45.2
    145.8%
    18.8
    117.5%
    Week 4
    45.8
    190.8%
    51.6
    166.5%
    25.0
    156.3%
    Week 8
    41.7
    173.8%
    70.0
    225.8%
    20.0
    125%
    Week 12
    43.5
    181.3%
    73.3
    236.5%
    31.3
    195.6%
    Week 16
    52.2
    217.5%
    70.0
    225.8%
    43.8
    273.8%
    Week 20
    47.8
    199.2%
    73.3
    236.5%
    50.0
    312.5%
    Week 24
    56.5
    235.4%
    70.0
    225.8%
    37.5
    234.4%
    Week 28
    56.5
    235.4%
    73.3
    236.5%
    37.5
    234.4%
    Week 32
    60.9
    253.8%
    70.0
    225.8%
    43.8
    273.8%
    Week 36
    59.1
    246.3%
    75.9
    244.8%
    43.8
    273.8%
    Week 40
    61.9
    257.9%
    78.6
    253.5%
    40.0
    250%
    Week 44
    50.0
    208.3%
    72.4
    233.5%
    37.5
    234.4%
    Week 48
    57.1
    237.9%
    75.0
    241.9%
    37.5
    234.4%
    Week 52
    57.1
    237.9%
    71.4
    230.3%
    37.5
    234.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 21.90
    Confidence Interval (2-Sided) 80%
    0.76 to 43.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 38.57
    Confidence Interval (2-Sided) 80%
    19.56 to 57.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 19.64
    Confidence Interval (2-Sided) 80%
    -1.14 to 40.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 33.93
    Confidence Interval (2-Sided) 80%
    14.95 to 52.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    8. Secondary Outcome
    Title Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Baseline
    8.3
    34.6%
    3.2
    10.3%
    12.5
    78.1%
    Day 7
    4.2
    17.5%
    0
    0%
    0
    0%
    Week 4
    4.2
    17.5%
    3.2
    10.3%
    0
    0%
    Week 8
    8.3
    34.6%
    6.7
    21.6%
    0
    0%
    Week 12
    4.3
    17.9%
    6.7
    21.6%
    0
    0%
    Week 16
    4.3
    17.9%
    3.3
    10.6%
    0
    0%
    Week 20
    4.3
    17.9%
    6.7
    21.6%
    0
    0%
    Week 24
    4.3
    17.9%
    6.7
    21.6%
    0
    0%
    Week 28
    4.3
    17.9%
    3.3
    10.6%
    0
    0%
    Week 32
    4.3
    17.9%
    3.3
    10.6%
    0
    0%
    Week 36
    4.5
    18.8%
    3.4
    11%
    0
    0%
    Week 40
    0
    0%
    3.6
    11.6%
    0
    0%
    Week 44
    5.0
    20.8%
    3.4
    11%
    0
    0%
    Week 48
    4.8
    20%
    3.6
    11.6%
    0
    0%
    Week 52
    4.8
    20%
    3.6
    11.6%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 0
    Confidence Interval () %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 3.57
    Confidence Interval (2-Sided) 80%
    -0.92 to 8.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 4.76
    Confidence Interval (2-Sided) 80%
    -1.19 to 10.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentage of Participants
    Estimated Value 3.57
    Confidence Interval (2-Sided) 80%
    -0.92 to 8.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    9. Secondary Outcome
    Title Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Day 7
    -93.56
    -94.31
    -76.01
    Week 4
    -132.27
    -130.11
    -122.07
    Week 8
    -134.47
    -136.15
    -127.64
    Week 12
    -142.26
    -139.63
    -126.63
    Week 16
    -134.94
    -137.81
    -120.48
    Week 20
    -125.05
    -125.35
    -120.70
    Week 24
    -121.13
    -108.66
    -131.29
    Week 28
    -131.58
    -116.76
    -130.29
    Week 32
    -127.85
    -123.44
    -134.29
    Week 36
    -114.27
    -114.97
    -149.26
    Week 40
    -137.54
    -123.31
    -137.99
    Week 44
    -135.30
    -110.26
    -135.70
    Week 48
    -125.93
    -121.67
    -130.76
    Week 52
    -140.95
    -134.99
    -136.10
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.45
    Confidence Interval (2-Sided) 80%
    -29.81 to 30.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 14.68
    Confidence Interval (2-Sided) 80%
    -14.29 to 43.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -4.85
    Confidence Interval (2-Sided) 80%
    -30.57 to 20.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.12
    Confidence Interval (2-Sided) 80%
    -23.57 to 25.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    10. Secondary Outcome
    Title Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Day 7
    -88.87
    -84.23
    -80.08
    Week 4
    -127.20
    -123.10
    -111.58
    Week 8
    -132.03
    -131.25
    -117.04
    Week 12
    -134.70
    -132.87
    -122.39
    Week 16
    -132.96
    -132.50
    -122.70
    Week 20
    -114.97
    -118.89
    -120.77
    Week 24
    -101.62
    -99.35
    -121.33
    Week 28
    -129.68
    -109.89
    -127.95
    Week 32
    -121.10
    -116.35
    -127.20
    Week 36
    -101.98
    -102.69
    -118.89
    Week 40
    -138.55
    -121.34
    -126.32
    Week 44
    -130.50
    -103.31
    -124.89
    Week 48
    -126.45
    -102.30
    -123.89
    Week 52
    -138.53
    -122.53
    -129.89
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -12.23
    Confidence Interval (2-Sided) 80%
    -36.60 to 12.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 40: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 4.98
    Confidence Interval (2-Sided) 80%
    -18.50 to 28.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q12W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q12W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -8.64
    Confidence Interval (2-Sided) 80%
    -30.42 to 13.14
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q12W arm minus Ranibizumab Q4W arm.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 6 mg Faricimab Q16W, 0.5 mg Ranibizumab Q4W
    Comments Week 52: Faricimab Q16W vs. Ranibizumab Q4W
    Type of Statistical Test Other
    Comments The focus of this trial was estimation rather than hypothesis testing.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 7.36
    Confidence Interval (2-Sided) 80%
    -13.65 to 28.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments The difference was calculated as Faricimab Q16W arm minus Ranibizumab Q4W arm.
    11. Secondary Outcome
    Title Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Baseline
    4.2
    17.5%
    29.0
    93.5%
    18.8
    117.5%
    Day 7
    21.7
    90.4%
    38.7
    124.8%
    25.0
    156.3%
    Week 4
    29.2
    121.7%
    48.4
    156.1%
    50.0
    312.5%
    Week 8
    33.3
    138.8%
    46.7
    150.6%
    26.7
    166.9%
    Week 12
    39.1
    162.9%
    43.3
    139.7%
    37.5
    234.4%
    Week 16
    47.8
    199.2%
    50.0
    161.3%
    37.5
    234.4%
    Week 20
    43.5
    181.3%
    53.3
    171.9%
    18.8
    117.5%
    Week 24
    30.4
    126.7%
    50.0
    161.3%
    31.3
    195.6%
    Week 28
    26.1
    108.8%
    53.3
    171.9%
    31.3
    195.6%
    Week 32
    26.1
    108.8%
    50.0
    161.3%
    31.3
    195.6%
    Week 36
    31.8
    132.5%
    44.8
    144.5%
    37.5
    234.4%
    Week 40
    38.1
    158.8%
    57.1
    184.2%
    33.3
    208.1%
    Week 44
    55.0
    229.2%
    48.3
    155.8%
    43.8
    273.8%
    Week 48
    38.1
    158.8%
    53.6
    172.9%
    62.5
    390.6%
    Week 52
    38.1
    158.8%
    35.7
    115.2%
    62.5
    390.6%
    12. Secondary Outcome
    Title Percentage of Participants With No Subretinal Fluid at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Baseline
    20.8
    86.7%
    12.9
    41.6%
    25.0
    156.3%
    Day 7
    39.1
    162.9%
    29.0
    93.5%
    31.3
    195.6%
    Week 4
    70.8
    295%
    77.4
    249.7%
    62.5
    390.6%
    Week 8
    83.3
    347.1%
    86.7
    279.7%
    80.0
    500%
    Week 12
    91.3
    380.4%
    90.0
    290.3%
    75.0
    468.8%
    Week 16
    87.0
    362.5%
    96.7
    311.9%
    75.0
    468.8%
    Week 20
    69.6
    290%
    70.0
    225.8%
    87.5
    546.9%
    Week 24
    65.2
    271.7%
    66.7
    215.2%
    75.0
    468.8%
    Week 28
    91.3
    380.4%
    70.0
    225.8%
    75.0
    468.8%
    Week 32
    69.6
    290%
    80.0
    258.1%
    68.8
    430%
    Week 36
    68.2
    284.2%
    72.4
    233.5%
    81.3
    508.1%
    Week 40
    81.0
    337.5%
    89.3
    288.1%
    86.7
    541.9%
    Week 44
    80.0
    333.3%
    75.9
    244.8%
    81.3
    508.1%
    Week 48
    71.4
    297.5%
    64.3
    207.4%
    87.5
    546.9%
    Week 52
    81.0
    337.5%
    89.3
    288.1%
    87.5
    546.9%
    13. Secondary Outcome
    Title Percentage of Participants With No Cysts at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Baseline
    33.3
    138.8%
    48.4
    156.1%
    37.5
    234.4%
    Day 7
    65.2
    271.7%
    83.9
    270.6%
    75.0
    468.8%
    Week 4
    87.5
    364.6%
    87.1
    281%
    87.5
    546.9%
    Week 8
    83.3
    347.1%
    83.3
    268.7%
    86.7
    541.9%
    Week 12
    91.3
    380.4%
    83.3
    268.7%
    68.8
    430%
    Week 16
    91.3
    380.4%
    83.3
    268.7%
    75.0
    468.8%
    Week 20
    91.3
    380.4%
    80.0
    258.1%
    68.8
    430%
    Week 24
    73.9
    307.9%
    76.7
    247.4%
    68.8
    430%
    Week 28
    95.7
    398.8%
    70.0
    225.8%
    68.8
    430%
    Week 32
    82.6
    344.2%
    76.7
    247.4%
    75.0
    468.8%
    Week 36
    77.3
    322.1%
    79.3
    255.8%
    68.8
    430%
    Week 40
    85.7
    357.1%
    78.6
    253.5%
    80.0
    500%
    Week 44
    100.0
    416.7%
    72.4
    233.5%
    87.5
    546.9%
    Week 48
    95.2
    396.7%
    85.7
    276.5%
    87.5
    546.9%
    Week 52
    100.0
    416.7%
    78.6
    253.5%
    87.5
    546.9%
    14. Secondary Outcome
    Title Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
    Description 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.
    Time Frame Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Baseline
    8.3
    34.6%
    29.0
    93.5%
    12.5
    78.1%
    Day 7
    13.0
    54.2%
    29.0
    93.5%
    12.5
    78.1%
    Week 4
    8.3
    34.6%
    22.6
    72.9%
    12.5
    78.1%
    Week 8
    8.3
    34.6%
    23.3
    75.2%
    13.3
    83.1%
    Week 12
    8.7
    36.3%
    26.7
    86.1%
    12.5
    78.1%
    Week 16
    8.7
    36.3%
    23.3
    75.2%
    12.5
    78.1%
    Week 20
    13.0
    54.2%
    23.3
    75.2%
    12.5
    78.1%
    Week 24
    13.0
    54.2%
    23.3
    75.2%
    12.5
    78.1%
    Week 28
    13.0
    54.2%
    20.0
    64.5%
    12.5
    78.1%
    Week 32
    13.0
    54.2%
    23.3
    75.2%
    12.5
    78.1%
    Week 36
    4.5
    18.8%
    20.7
    66.8%
    12.5
    78.1%
    Week 40
    4.8
    20%
    21.4
    69%
    13.3
    83.1%
    Week 44
    5.0
    20.8%
    17.2
    55.5%
    12.5
    78.1%
    Week 48
    9.5
    39.6%
    17.9
    57.7%
    12.5
    78.1%
    Week 52
    14.3
    59.6%
    14.3
    46.1%
    12.5
    78.1%
    15. Secondary Outcome
    Title Mean Baseline Value and Mean Change From Baseline of Total Area of Choroidal Neovascularization (CNV) at Week 40 and Week 52
    Description The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA).
    Time Frame Baseline, Week 40, Week 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Baseline (BL): Absolute Value
    7.1
    (3.9)
    5.9
    (3.8)
    7.3
    (2.9)
    Change from BL at Week 40
    -4.7
    (4.3)
    -3.9
    (3.7)
    -4.6
    (3.5)
    Change from BL at Week 52
    -5.4
    (4.0)
    -4.2
    (3.4)
    -4.5
    (3.2)
    16. Secondary Outcome
    Title Mean Baseline Value and Mean Change From Baseline of Total Area of CNV Component at Week 40 and Week 52
    Description 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).
    Time Frame Baseline, Week 40, Week 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Baseline (BL): Absolute Value
    7.0
    (3.8)
    5.8
    (3.6)
    7.1
    (3.0)
    Change from BL at Week 40
    -5.0
    (4.2)
    -4.0
    (4.0)
    -4.7
    (3.4)
    Change from BL at Week 52
    -5.6
    (4.0)
    -4.3
    (3.7)
    -4.8
    (3.2)
    17. Secondary Outcome
    Title Mean Baseline Value and Mean Change From Baseline of Total Area of Leakage at Week 40 and Week 52
    Description The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA).
    Time Frame Baseline, Week 40, Week 52

    Outcome Measure Data

    Analysis Population Description
    Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Baseline (BL): Absolute Value
    7.0
    (3.8)
    6.1
    (3.4)
    7.6
    (2.9)
    Change from BL at Week 40
    -5.0
    (4.2)
    -4.3
    (3.9)
    -5.3
    (3.7)
    Change from BL at Week 52
    -5.6
    (4.0)
    -4.6
    (3.5)
    -5.3
    (3.5)
    18. Secondary Outcome
    Title Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline
    Description Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to faricimab by a validated enzyme-linked immunosorbent assay (ELISA).
    Time Frame Predose at Baseline (Day 1), Weeks 16, 24, 28, 44, and 52

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W
    Arm/Group Description 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). 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.
    Measure Participants 24 31
    ADA Negative to ADA Negative
    21
    87.5%
    25
    80.6%
    ADA Negative to ADA Positive
    1
    4.2%
    4
    12.9%
    Missing to ADA Negative
    0
    0%
    1
    3.2%
    Missing to ADA Positive
    1
    4.2%
    0
    0%
    No Post-Baseline ADA Assessment
    1
    4.2%
    1
    3.2%
    19. Secondary Outcome
    Title Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
    Description 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.
    Time Frame From Baseline until 28 days after the last dose of study drug (up to 52 weeks)

    Outcome Measure Data

    Analysis Population Description
    Safety Population: participants who received at least one dose of the study treatment, grouped according to treatment received.
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    Measure Participants 24 31 16
    Any Adverse Event (AE)
    18
    75%
    23
    74.2%
    13
    81.3%
    Serious AE (SAE)
    4
    16.7%
    3
    9.7%
    0
    0%
    SAE Leading to Withdrawal from Treatment
    0
    0%
    0
    0%
    0
    0%
    SAE Leading to Dose Modification/Interruption
    1
    4.2%
    0
    0%
    0
    0%
    Serious Ocular AE
    0
    0%
    0
    0%
    0
    0%
    Serious Non-Ocular AE
    4
    16.7%
    3
    9.7%
    0
    0%
    AE Leading to Withdrawal from Treatment
    0
    0%
    0
    0%
    0
    0%
    AE Leading to Dose Modification/Interruption
    2
    8.3%
    0
    0%
    0
    0%
    Ocular AE in the Study Eye
    9
    37.5%
    11
    35.5%
    8
    50%
    Ocular AE in the Fellow Eye
    6
    25%
    5
    16.1%
    6
    37.5%
    Non-Ocular AE
    14
    58.3%
    20
    64.5%
    9
    56.3%

    Adverse Events

    Time Frame From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
    Adverse Event Reporting Description
    Arm/Group Title 6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Arm/Group Description 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). 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. 0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
    All Cause Mortality
    6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/24 (4.2%) 2/31 (6.5%) 0/16 (0%)
    Serious Adverse Events
    6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/24 (16.7%) 3/31 (9.7%) 0/16 (0%)
    Cardiac disorders
    Acute left ventricular failure 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Atrial fibrillation 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Coronary artery disease 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Ear and labyrinth disorders
    Vertigo 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Infections and infestations
    Sepsis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Injury, poisoning and procedural complications
    Fall 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic neoplasm 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Nervous system disorders
    Headache 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Ischaemic stroke 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Psychiatric disorders
    Mental status changes 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Other (Not Including Serious) Adverse Events
    6 mg Faricimab Q12W 6 mg Faricimab Q16W 0.5 mg Ranibizumab Q4W
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 18/24 (75%) 22/31 (71%) 13/16 (81.3%)
    Cardiac disorders
    Arrhythmia 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Cardiac failure congestive 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Endocrine disorders
    Hypothyroidism 0/24 (0%) 2/31 (6.5%) 0/16 (0%)
    Eye disorders
    Conjunctival haemorrhage 5/24 (20.8%) 4/31 (12.9%) 4/16 (25%)
    Neovascular age-related macular degeneration 3/24 (12.5%) 0/31 (0%) 2/16 (12.5%)
    Eye pain 2/24 (8.3%) 0/31 (0%) 2/16 (12.5%)
    Retinal haemorrhage 2/24 (8.3%) 0/31 (0%) 2/16 (12.5%)
    Cataract 2/24 (8.3%) 1/31 (3.2%) 0/16 (0%)
    Choroidal neovascularisation 1/24 (4.2%) 0/31 (0%) 1/16 (6.3%)
    Dry eye 0/24 (0%) 1/31 (3.2%) 1/16 (6.3%)
    Maculopathy 0/24 (0%) 2/31 (6.5%) 0/16 (0%)
    Ocular discomfort 0/24 (0%) 1/31 (3.2%) 1/16 (6.3%)
    Vitreous detachment 1/24 (4.2%) 0/31 (0%) 1/16 (6.3%)
    Vitreous floaters 1/24 (4.2%) 0/31 (0%) 1/16 (6.3%)
    Eye haemorrhage 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Macular oedema 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Ocular hypertension 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Optic disc haemorrhage 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Vision blurred 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Anterior chamber flare 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Chalazion 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Eye irritation 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Eye pruritus 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Foreign body sensation in eyes 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Iritis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Subretinal fibrosis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Visual acuity reduced 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Punctate keratitis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Chorioretinal atrophy 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Macular fibrosis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Retinal drusen 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Vitreous disorder 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Gastrointestinal disorders
    Constipation 0/24 (0%) 1/31 (3.2%) 1/16 (6.3%)
    Abdominal pain 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Gastrooesophageal reflux disease 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Hiatus hernia 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Inguinal hernia 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    General disorders
    Pain 0/24 (0%) 1/31 (3.2%) 1/16 (6.3%)
    Cyst 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Fatigue 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Inflammatory pain 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Hepatobiliary disorders
    Cholecystitis 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Immune system disorders
    Hypersensitivity 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Infections and infestations
    Nasopharyngitis 4/24 (16.7%) 2/31 (6.5%) 1/16 (6.3%)
    Urinary tract infection 1/24 (4.2%) 2/31 (6.5%) 1/16 (6.3%)
    Influenza 1/24 (4.2%) 2/31 (6.5%) 0/16 (0%)
    Upper respiratory tract infection 1/24 (4.2%) 0/31 (0%) 1/16 (6.3%)
    Fungal skin infection 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Tooth infection 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Vaginal infection 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Sinusitis 1/24 (4.2%) 1/31 (3.2%) 0/16 (0%)
    Abscess limb 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Catheter site infection 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Cellulitis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Ear infection 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Gastroenteritis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Gastroenteritis viral 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Joint abscess 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Mycobacterium avium complex infection 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Rhinitis 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Subcutaneous abscess 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Urethritis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Injury, poisoning and procedural complications
    Fall 0/24 (0%) 5/31 (16.1%) 1/16 (6.3%)
    Muscle strain 0/24 (0%) 2/31 (6.5%) 0/16 (0%)
    Rib fracture 0/24 (0%) 2/31 (6.5%) 0/16 (0%)
    Eye contusion 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Investigations
    Biopsy palate 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Blood sodium decreased 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Catheterisation cardiac 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Intraocular pressure increased 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Ophthalmological examination abnormal 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Metabolism and nutrition disorders
    Diabetes mellitus 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Iron deficiency 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Arthralgia 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Back pain 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Osteoarthritis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Osteopenia 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma 2/24 (8.3%) 0/31 (0%) 0/16 (0%)
    Squamous cell carcinoma of skin 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Squamous cell carcinoma 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Eye naevus 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Nervous system disorders
    Headache 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Cerebral infarction 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Cerebral small vessel ischaemic disease 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Neuropathy peripheral 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Psychiatric disorders
    Anxiety 1/24 (4.2%) 2/31 (6.5%) 0/16 (0%)
    Renal and urinary disorders
    Nephrolithiasis 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Bladder pain 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/24 (0%) 0/31 (0%) 1/16 (6.3%)
    Asthma 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Emphysema 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Hypoxia 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Pulmonary oedema 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Rhinitis allergic 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Rhinorrhoea 1/24 (4.2%) 0/31 (0%) 0/16 (0%)
    Vascular disorders
    Hypertension 0/24 (0%) 1/31 (3.2%) 1/16 (6.3%)
    Hypotension 1/24 (4.2%) 1/31 (3.2%) 0/16 (0%)
    Aortic stenosis 0/24 (0%) 1/31 (3.2%) 0/16 (0%)
    Aneurysm 0/24 (0%) 1/31 (3.2%) 0/16 (0%)

    Limitations/Caveats

    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.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Medical Communications
    Organization Hoffmann-La Roche
    Phone 800-821-8590
    Email genentech@druginfo.com
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03038880
    Other Study ID Numbers:
    • CR39521
    First Posted:
    Feb 1, 2017
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020