Choroidal Neovascularization
Conditions
Brief summary
This multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study was designed to allow the evaluation of RO6867461 in a treatment-naive population (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per participant was chosen as the study eye.
Interventions
DRUGSham Procedure
The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in treatment arm D at applicable visits to maintain masking.
DRUGFaricimab
Faricimab will be administered as per the regimen specified in the individual arm.
DRUGRanibizumab
Ranibizumab will be administered as per the regimen specified in the individual arm.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment-naive with CNV secondary to AMD, with subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity by FFA or SD-OCT * Active CNV
Exclusion criteria
* CNV due to causes other than AMD * Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area * Cataract surgery within 3 months of baseline, or any other previous intraocular surgery * Major illness or surgery within 1 month prior to Screening * Glycosylated hemoglobin (HbA1c) above 7.5% * Uncontrolled blood pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | Baseline, Week 36 | 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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. 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 primary analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism. |
| Mean Change From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders | Weeks 12 and 36 | 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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. 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 primary analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Treatment-Naive Participants | Week 36 | 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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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 outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Anti-VEGF Incomplete Responders | Week 36 | 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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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. Missing values were not imputed; it was assumed that the data were missing at random. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Treatment-Naive Participants | Week 36 | 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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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 outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random. |
| Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Anti-VEGF Incomplete Responders | Week 36 | 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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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. Missing values were not imputed; it was assumed that the data were missing at random. |
| Mean Change From Baseline in Foveal Center Point Thickness at Week 36, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT), in Treatment-Naive Participants | Baseline, Week 36 | Foveal center point thickness (FCPT) is 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. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism. |
| Mean Change From Week 12 in Foveal Center Point Thickness at Week 36, as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Weeks 12 and 36 | Foveal center point thickness (FCPT) is 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. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism. |
| Mean Change From Baseline in Central Subfield Thickness at Week 36, as Measured by SD-OCT, in Treatment-Naive Participants | Baseline, Week 36 | Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism. |
| Mean Change From Week 12 in Central Subfield Thickness at Week 36, as Measured by SD-OCT in Anti-VEGF Incomplete Responders | Weeks 12 and 36 | Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism. |
| Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Baseline, Week 36 | The presence of cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid, 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. Intraretinal fluid was defined as the presence of fluid within the retina. Pigment epithelial detachment was defined as the presence of a detachment of the pigment epithelium from the Bruch's membrane. 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. |
| Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Weeks 12 and 36 | The presence of cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid, 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. Intraretinal fluid was defined as the presence of fluid within the retina. Pigment epithelial detachment was defined as the presence of a detachment of the pigment epithelium from the Bruch's membrane. 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. |
| Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by Fundus Fluorescein Angiography (FFA), in Treatment-Naive Participants | Baseline, Week 36 | The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA). This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism. |
| Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders | Weeks 12 and 36 | The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA). |
| Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Treatment-Naive Participants | Baseline, Week 36 | 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). This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism. |
| Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders | Weeks 12 and 36 | 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). |
| Mean Change From Baseline in Total Area of Leakage at Week 36, as Measured by FFA, in Treatment-Naive Participants | Baseline, Week 36 | The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA). This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism. |
| Percentage of Participants Gaining Greater Than or Equal to (≥) 15 Letters From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | Baseline, Week 36 | 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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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 outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random. |
| Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | From Baseline until 28 days after the last dose of study treatment (up to 36 weeks) | This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs leading to discontinuation (withdrawal) of treatment with study drug, and AEs with fatal outcome. 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. |
| Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | From Baseline until 28 days after the last dose of study treatment (up to 36 weeks) | The investigator assessed adverse event severity 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. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria. |
| Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | From Baseline until 28 days after the last dose of study treatment (up to 36 weeks) | The investigator assessed adverse event severity 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. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria. |
| Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) | Abnormal systolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<70 (low) to \>140 (high) millimetres of mercury (mmHg). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. |
| Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) | Abnormal diastolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<40 (low) to \>90 (high) millimetres of mercury (mmHg). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. |
| Number of Participants With Abnormal Heart Rate, in All Participants | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) | Abnormal heart rate (supine) was defined as any value outside of the standard reference range, from \<40 (low) to \>100 (high) beats per minute. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. |
| Number of Participants With Abnormal Body Temperature, in All Participants | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) | Abnormal body temperature (supine) was defined as any value outside of the standard reference range, from \<36.5 (low) to \>37.5 (high) degrees Celsius. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. |
| Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks) | Clinical laboratory tests for hematology and coagulation parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. Abs. = absolute count; Corp. = corpuscular; Ery. = erythrocyte; INR = International Normalized Ratio |
| Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks) | Clinical laboratory tests for blood chemistry parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. GGT = gamma-glutamyltransferase; SGOT/AST = serum glutamic oxaloacetic transaminase / aspartate aminotransferase; SGPT/ALT = serum glutamic pyruvic transaminase / alanine aminotransferase |
| Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Baseline, 0.5 hours postdose on Day 1, predose and 0.5 hours postdose at Weeks 4, 8, 12, 16, 20, 24, 28, and 32, and at Weeks 1, 13, and 36 | Intraocular pressure is the fluid pressure inside the eye. The method used to measure intraocular pressure (e.g., Goldmann tonometry) for each participant was to be applied consistently by the investigator throughout the study. On the day of dosing, intraocular pressure was monitored at 30 minutes post-treatment administration, and if intraocular pressure was ≥30 mmHg in the study eye, it was reassessed at 1 hour post-treatment administration. |
| Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | Baseline, Predose (0 hour) on Days 1, 28, 84, 112, 168, and 252 or early termination (up to 36 weeks) | Blood samples were obtained for measurement of anti-faricimab antibodies by a validated enzyme-linked immunosorbent assay (ELISA). |
| Mean Plasma Concentration of Faricimab Over Time, in All Participants | Predose (on days when treatment was administered) at Baseline and Weeks 4, 12, 13, 16, 24, and 36 | Plasma concentrations of faricimab were measured by a specific validated enzyme-linked immunoabsorbent assay (ELISA) only from samples of participants randomized to receive faricimab. Baseline was defined as the last non-missing predose assessment. The lower limit of quantification (LLOQ) for the faricimab assay was 0.800 nanograms per millilitre (ng/mL). Values below the limit of quantification were imputed as LLOQ divided by 2. |
| Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Baseline, Weeks 4, 12, 13, 16, 24, and 36 | The concentration of free VEGF was determined in plasma samples using an enzyme-linked immunosorbent assay (ELISA) method. The lower limit of quantification (LLOQ) of the assay was 15.6 picograms per millilitre (pg/mL). Plasma free VEGF concentrations below the limit of quantification were imputed as LLOQ divided by 2. |
| Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline, Weeks 4, 12, 13, 16, 24, and 36 | Total Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.09 nanograms per millilitre (ng/mL). Plasma total Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2. |
| Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline, Weeks 4, 12, 13, 16, 24, and 36 | Free Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.9 nanograms per millilitre (ng/mL). Plasma free Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2. |
| Mean Change From Week 12 in Total Area of Leakage at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders | Weeks 12 and 36 | The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA). |
| Percentage of Participants Gaining ≥15 Letters From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders | Weeks 12 and 36 | 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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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. Missing values were not imputed; it was assumed that the data were missing at random. |
Countries
United States
Participant flow
Pre-assignment details
A total of 273 patients were randomized, but 10 participants in total were excluded from the analysis populations, 1, 3, 1, and 5 from Arms B, C, D, and E, respectively, because of Good Clinical Practice (GCP) violations at a single site.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36. | 68 |
| Arm B: Faricimab, 1.5 mg Q4W Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36. | 46 |
| Arm C: Faricimab, 6 mg Q4W Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36. | 39 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36. | 46 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36. | 64 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 0 | 0 | 5 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 2 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Arm D: Faricimab, 6 mg Every 4-8 Weeks | Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Arm C: Faricimab, 6 mg Q4W | Arm B: Faricimab, 1.5 mg Q4W | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 79.2 Years STANDARD_DEVIATION 8.3 | 80.0 Years STANDARD_DEVIATION 8 | 76.4 Years STANDARD_DEVIATION 8.9 | 78.0 Years STANDARD_DEVIATION 9.1 | 78.2 Years STANDARD_DEVIATION 8.9 | 78.3 Years STANDARD_DEVIATION 8.7 |
| Best-Corrected Visual Acuity (BCVA) Letter Score Category in the Study Eye at Baseline Assessment Missing | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Best-Corrected Visual Acuity (BCVA) Letter Score Category in the Study Eye at Baseline BCVA Letter Score ≤54 | 26 Participants | 21 Participants | 22 Participants | 15 Participants | 20 Participants | 104 Participants |
| Best-Corrected Visual Acuity (BCVA) Letter Score Category in the Study Eye at Baseline BCVA Letter Score >54 | 38 Participants | 25 Participants | 45 Participants | 24 Participants | 26 Participants | 158 Participants |
| Best-Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Baseline | 55.7 BCVA Letters STANDARD_DEVIATION 11.6 | 56.3 BCVA Letters STANDARD_DEVIATION 11.5 | 55.2 BCVA Letters STANDARD_DEVIATION 12.7 | 56.2 BCVA Letters STANDARD_DEVIATION 12.2 | 56.7 BCVA Letters STANDARD_DEVIATION 11.1 | 55.9 BCVA Letters STANDARD_DEVIATION 11.9 |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline Assessment Missing | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline Classic CNV | 10 Participants | 6 Participants | 8 Participants | 7 Participants | 6 Participants | 37 Participants |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline Classic & Occult CNV | 21 Participants | 20 Participants | 26 Participants | 12 Participants | 19 Participants | 98 Participants |
| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline Occult CNV | 33 Participants | 19 Participants | 33 Participants | 20 Participants | 20 Participants | 125 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 4 Participants | 0 Participants | 3 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 42 Participants | 64 Participants | 38 Participants | 43 Participants | 248 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Presence or Absence of Polypoidal Choroidal Vasculopathy (PCV) in the Study Eye at Baseline Assessment Missing | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Presence or Absence of Polypoidal Choroidal Vasculopathy (PCV) in the Study Eye at Baseline PCV Absent | 57 Participants | 40 Participants | 61 Participants | 36 Participants | 42 Participants | 236 Participants |
| Presence or Absence of Polypoidal Choroidal Vasculopathy (PCV) in the Study Eye at Baseline PCV Present | 7 Participants | 5 Participants | 7 Participants | 3 Participants | 3 Participants | 25 Participants |
| Presence or Absence of Retinal Angiomatous Proliferation (RAP) in the Study Eye at Baseline Assessment Missing | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 9 Participants |
| Presence or Absence of Retinal Angiomatous Proliferation (RAP) in the Study Eye at Baseline RAP Absent | 47 Participants | 29 Participants | 44 Participants | 29 Participants | 30 Participants | 179 Participants |
| Presence or Absence of Retinal Angiomatous Proliferation (RAP) in the Study Eye at Baseline RAP Present | 16 Participants | 14 Participants | 22 Participants | 9 Participants | 14 Participants | 75 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 64 Participants | 44 Participants | 66 Participants | 39 Participants | 45 Participants | 258 Participants |
| Sex: Female, Male Female | 40 Participants | 34 Participants | 39 Participants | 27 Participants | 32 Participants | 172 Participants |
| Sex: Female, Male Male | 24 Participants | 12 Participants | 29 Participants | 12 Participants | 14 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 46 | 0 / 39 | 0 / 46 | 1 / 64 |
| other Total, other adverse events | 39 / 67 | 31 / 46 | 24 / 39 | 32 / 46 | 40 / 64 |
| serious Total, serious adverse events | 9 / 67 | 11 / 46 | 7 / 39 | 5 / 46 | 8 / 64 |
Outcome results
Primary
Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants
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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. 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 primary analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Time frame: Baseline, Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | 7.61 BCVA Letters |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | 9.18 BCVA Letters |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | 6.02 BCVA Letters |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | 6.10 BCVA Letters |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.p-value: 0.524480% CI: [-1.6, 4.74]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.p-value: 0.530880% CI: [-4.86, 1.67]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.p-value: 0.530980% CI: [-4.62, 1.59]Mixed Model for Repeated Measures
Primary
Mean Change From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders
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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. 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 primary analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Time frame: Weeks 12 and 36
Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders | 1.72 BCVA Letters |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders | 0.04 BCVA Letters |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that the Arm E mean was different from Arm A mean.p-value: 0.303480% CI: [-3.77, 0.42]Mixed Model for Repeated Measures
Secondary
Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint
Blood samples were obtained for measurement of anti-faricimab antibodies by a validated enzyme-linked immunosorbent assay (ELISA).
Time frame: Baseline, Predose (0 hour) on Days 1, 28, 84, 112, 168, and 252 or early termination (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment. The analysis only included participants who received treatment with faricimab (i.e., Arm A was excluded) and had evaluable samples at baseline and any post-baseline timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm B: Faricimab, 1.5 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to ADA Negative | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to ADA Positive | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to ADA Negative | 41 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to ADA Positive | 3 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to Missing | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to Missing | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to ADA Negative | 35 Participants |
| Arm C: Faricimab, 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to Missing | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to ADA Positive | 3 Participants |
| Arm C: Faricimab, 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to ADA Negative | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to ADA Positive | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to Missing | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to Missing | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to ADA Negative | 36 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to ADA Negative | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to Missing | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to ADA Positive | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to ADA Positive | 9 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to ADA Positive | 3 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to Missing | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to ADA Negative | 54 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Negative to ADA Positive | 6 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to Missing | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint | ADA Positive to ADA Negative | 0 Participants |
Secondary
Mean Change From Baseline in Central Subfield Thickness at Week 36, as Measured by SD-OCT, in Treatment-Naive Participants
Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Time frame: Baseline, Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Central Subfield Thickness at Week 36, as Measured by SD-OCT, in Treatment-Naive Participants | -176.18 micrometres (μm) |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Central Subfield Thickness at Week 36, as Measured by SD-OCT, in Treatment-Naive Participants | -156.73 micrometres (μm) |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Central Subfield Thickness at Week 36, as Measured by SD-OCT, in Treatment-Naive Participants | -173.40 micrometres (μm) |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Central Subfield Thickness at Week 36, as Measured by SD-OCT, in Treatment-Naive Participants | -147.66 micrometres (μm) |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.p-value: 0.162480% CI: [1.61, 37.29]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.p-value: 0.847580% CI: [-15.8, 21.37]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.p-value: 0.038180% CI: [10.93, 46.11]Mixed Model for Repeated Measures
Secondary
Mean Change From Baseline in Foveal Center Point Thickness at Week 36, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT), in Treatment-Naive Participants
Foveal center point thickness (FCPT) is 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. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Time frame: Baseline, Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Foveal Center Point Thickness at Week 36, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT), in Treatment-Naive Participants | -194.00 micrometres (μm) |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Foveal Center Point Thickness at Week 36, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT), in Treatment-Naive Participants | -181.35 micrometres (μm) |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Foveal Center Point Thickness at Week 36, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT), in Treatment-Naive Participants | -193.12 micrometres (μm) |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Foveal Center Point Thickness at Week 36, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT), in Treatment-Naive Participants | -161.20 micrometres (μm) |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.p-value: 0.379880% CI: [-5.81, 31.11]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.p-value: 0.952980% CI: [-18.3, 20.03]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.p-value: 0.020880% CI: [14.65, 50.96]Mixed Model for Repeated Measures
Secondary
Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Free Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.9 nanograms per millilitre (ng/mL). Plasma free Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Baseline, Weeks 4, 12, 13, 16, 24, and 36
Population: Analysis included all randomized participants who had received study treatment and had evaluable pharmacodynamic samples at a given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 2.19 nanograms per millilitre (ng/mL) | Standard Deviation 1.38 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.16 nanograms per millilitre (ng/mL) | Standard Deviation 0.74 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.18 nanograms per millilitre (ng/mL) | Standard Deviation 0.9 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | 0.23 nanograms per millilitre (ng/mL) | Standard Deviation 1.12 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 0.00 nanograms per millilitre (ng/mL) | Standard Deviation 0.57 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 0.03 nanograms per millilitre (ng/mL) | Standard Deviation 0.92 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | 0.06 nanograms per millilitre (ng/mL) | Standard Deviation 0.77 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | 0.17 nanograms per millilitre (ng/mL) | Standard Deviation 0.95 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 0.23 nanograms per millilitre (ng/mL) | Standard Deviation 0.69 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 0.14 nanograms per millilitre (ng/mL) | Standard Deviation 0.37 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 1.81 nanograms per millilitre (ng/mL) | Standard Deviation 0.73 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.20 nanograms per millilitre (ng/mL) | Standard Deviation 0.93 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | 0.20 nanograms per millilitre (ng/mL) | Standard Deviation 0.57 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.25 nanograms per millilitre (ng/mL) | Standard Deviation 0.65 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 0.81 nanograms per millilitre (ng/mL) | Standard Deviation 1.11 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 1.88 nanograms per millilitre (ng/mL) | Standard Deviation 0.98 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | -0.05 nanograms per millilitre (ng/mL) | Standard Deviation 0.46 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | 0.12 nanograms per millilitre (ng/mL) | Standard Deviation 0.52 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | 0.15 nanograms per millilitre (ng/mL) | Standard Deviation 0.62 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.25 nanograms per millilitre (ng/mL) | Standard Deviation 0.49 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.28 nanograms per millilitre (ng/mL) | Standard Deviation 0.63 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | 0.21 nanograms per millilitre (ng/mL) | Standard Deviation 0.75 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | 0.22 nanograms per millilitre (ng/mL) | Standard Deviation 0.67 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 0.15 nanograms per millilitre (ng/mL) | Standard Deviation 0.62 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.51 nanograms per millilitre (ng/mL) | Standard Deviation 1.3 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.39 nanograms per millilitre (ng/mL) | Standard Deviation 0.58 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 1.73 nanograms per millilitre (ng/mL) | Standard Deviation 0.75 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 0.55 nanograms per millilitre (ng/mL) | Standard Deviation 0.75 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | -0.01 nanograms per millilitre (ng/mL) | Standard Deviation 0.59 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.06 nanograms per millilitre (ng/mL) | Standard Deviation 0.66 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.13 nanograms per millilitre (ng/mL) | Standard Deviation 0.59 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | -0.11 nanograms per millilitre (ng/mL) | Standard Deviation 0.65 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | -0.07 nanograms per millilitre (ng/mL) | Standard Deviation 0.55 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 1.95 nanograms per millilitre (ng/mL) | Standard Deviation 1.12 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 0.32 nanograms per millilitre (ng/mL) | Standard Deviation 0.93 |
Secondary
Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants
The concentration of free VEGF was determined in plasma samples using an enzyme-linked immunosorbent assay (ELISA) method. The lower limit of quantification (LLOQ) of the assay was 15.6 picograms per millilitre (pg/mL). Plasma free VEGF concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Baseline, Weeks 4, 12, 13, 16, 24, and 36
Population: Analysis included all randomized participants who had received study treatment and had evaluable pharmacodynamic samples at a given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 15.25 picograms per millilitre (pg/mL) | Standard Deviation 10.6 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 1.91 picograms per millilitre (pg/mL) | Standard Deviation 28.59 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | -0.67 picograms per millilitre (pg/mL) | Standard Deviation 10.45 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | 1.52 picograms per millilitre (pg/mL) | Standard Deviation 19.45 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 0.52 picograms per millilitre (pg/mL) | Standard Deviation 12.2 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 2.62 picograms per millilitre (pg/mL) | Standard Deviation 21.69 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | 12.12 picograms per millilitre (pg/mL) | Standard Deviation 67.43 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | -3.28 picograms per millilitre (pg/mL) | Standard Deviation 10.61 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 5.47 picograms per millilitre (pg/mL) | Standard Deviation 52.19 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 3.94 picograms per millilitre (pg/mL) | Standard Deviation 33.25 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 16.83 picograms per millilitre (pg/mL) | Standard Deviation 12.08 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 10.35 picograms per millilitre (pg/mL) | Standard Deviation 50.09 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | -0.46 picograms per millilitre (pg/mL) | Standard Deviation 13.3 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | -0.79 picograms per millilitre (pg/mL) | Standard Deviation 11.86 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | -14.10 picograms per millilitre (pg/mL) | Standard Deviation 33.55 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 24.63 picograms per millilitre (pg/mL) | Standard Deviation 31.47 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | -9.26 picograms per millilitre (pg/mL) | Standard Deviation 27.76 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | -8.58 picograms per millilitre (pg/mL) | Standard Deviation 20.73 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | -9.86 picograms per millilitre (pg/mL) | Standard Deviation 33.05 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | -12.57 picograms per millilitre (pg/mL) | Standard Deviation 31.86 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | -12.16 picograms per millilitre (pg/mL) | Standard Deviation 32.48 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | -4.70 picograms per millilitre (pg/mL) | Standard Deviation 11.79 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | -6.28 picograms per millilitre (pg/mL) | Standard Deviation 10.84 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | -0.62 picograms per millilitre (pg/mL) | Standard Deviation 15.67 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | -1.34 picograms per millilitre (pg/mL) | Standard Deviation 13.69 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | -5.20 picograms per millilitre (pg/mL) | Standard Deviation 10.07 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 16.53 picograms per millilitre (pg/mL) | Standard Deviation 9.73 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | -7.36 picograms per millilitre (pg/mL) | Standard Deviation 10.67 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | -3.24 picograms per millilitre (pg/mL) | Standard Deviation 27.79 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | -8.17 picograms per millilitre (pg/mL) | Standard Deviation 29.73 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | -7.19 picograms per millilitre (pg/mL) | Standard Deviation 31.54 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | -5.34 picograms per millilitre (pg/mL) | Standard Deviation 32.9 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 3.75 picograms per millilitre (pg/mL) | Standard Deviation 53.99 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 22.60 picograms per millilitre (pg/mL) | Standard Deviation 27.79 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | -15.14 picograms per millilitre (pg/mL) | Standard Deviation 33.85 |
Secondary
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Intraocular pressure is the fluid pressure inside the eye. The method used to measure intraocular pressure (e.g., Goldmann tonometry) for each participant was to be applied consistently by the investigator throughout the study. On the day of dosing, intraocular pressure was monitored at 30 minutes post-treatment administration, and if intraocular pressure was ≥30 mmHg in the study eye, it was reassessed at 1 hour post-treatment administration.
Time frame: Baseline, 0.5 hours postdose on Day 1, predose and 0.5 hours postdose at Weeks 4, 8, 12, 16, 20, 24, 28, and 32, and at Weeks 1, 13, and 36
Population: Safety Population: all participants who received at least one dose of study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Baseline (BL): Absolute Value | 15.07 millimetres of mercury (mmHg) | Standard Deviation 3.38 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Day 1 (0.5 hr) | 1.90 millimetres of mercury (mmHg) | Standard Deviation 4.8 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 1 | -0.89 millimetres of mercury (mmHg) | Standard Deviation 3.52 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (Predose) | -0.02 millimetres of mercury (mmHg) | Standard Deviation 2.8 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (Predose) | -0.56 millimetres of mercury (mmHg) | Standard Deviation 3.85 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 13 | -0.77 millimetres of mercury (mmHg) | Standard Deviation 3.27 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (0.5 hr) | 1.64 millimetres of mercury (mmHg) | Standard Deviation 4.62 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (Predose) | -0.73 millimetres of mercury (mmHg) | Standard Deviation 3.72 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (0.5 hr) | 3.23 millimetres of mercury (mmHg) | Standard Deviation 3.91 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (0.5 hr) | 2.70 millimetres of mercury (mmHg) | Standard Deviation 4.21 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (Predose) | -0.27 millimetres of mercury (mmHg) | Standard Deviation 3.16 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (Predose) | -0.41 millimetres of mercury (mmHg) | Standard Deviation 3.39 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 36 | 0.00 millimetres of mercury (mmHg) | Standard Deviation 3.3 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (Predose) | 0.00 millimetres of mercury (mmHg) | Standard Deviation 3.29 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (Predose) | -0.17 millimetres of mercury (mmHg) | Standard Deviation 3.49 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (Predose) | -0.16 millimetres of mercury (mmHg) | Standard Deviation 3.02 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (0.5 hr) | 3.16 millimetres of mercury (mmHg) | Standard Deviation 4.28 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (0.5 hr) | 2.88 millimetres of mercury (mmHg) | Standard Deviation 4.45 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (0.5 hr) | 2.80 millimetres of mercury (mmHg) | Standard Deviation 4.81 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (0.5 hr) | 3.08 millimetres of mercury (mmHg) | Standard Deviation 4.01 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (0.5 hr) | 1.81 millimetres of mercury (mmHg) | Standard Deviation 5.1 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (0.5 hr) | 2.43 millimetres of mercury (mmHg) | Standard Deviation 3.41 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (Predose) | -1.00 millimetres of mercury (mmHg) | Standard Deviation 2.73 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 13 | -0.68 millimetres of mercury (mmHg) | Standard Deviation 3.12 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (0.5 hr) | 1.95 millimetres of mercury (mmHg) | Standard Deviation 5.35 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (Predose) | 0.02 millimetres of mercury (mmHg) | Standard Deviation 3.1 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 1 | -0.98 millimetres of mercury (mmHg) | Standard Deviation 3.47 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 36 | 0.25 millimetres of mercury (mmHg) | Standard Deviation 3.68 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (Predose) | -0.23 millimetres of mercury (mmHg) | Standard Deviation 3.63 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (Predose) | -1.40 millimetres of mercury (mmHg) | Standard Deviation 2.61 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (0.5 hr) | 2.90 millimetres of mercury (mmHg) | Standard Deviation 4.13 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (0.5 hr) | 2.70 millimetres of mercury (mmHg) | Standard Deviation 3.56 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (Predose) | 0.00 millimetres of mercury (mmHg) | Standard Deviation 4.3 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (Predose) | -0.32 millimetres of mercury (mmHg) | Standard Deviation 3.13 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Day 1 (0.5 hr) | 2.04 millimetres of mercury (mmHg) | Standard Deviation 5.32 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (0.5 hr) | 3.26 millimetres of mercury (mmHg) | Standard Deviation 4.04 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (0.5 hr) | 2.59 millimetres of mercury (mmHg) | Standard Deviation 4.64 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Baseline (BL): Absolute Value | 14.74 millimetres of mercury (mmHg) | Standard Deviation 3.08 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (Predose) | -0.33 millimetres of mercury (mmHg) | Standard Deviation 3.3 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (Predose) | -0.02 millimetres of mercury (mmHg) | Standard Deviation 2.88 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (0.5 hr) | 3.87 millimetres of mercury (mmHg) | Standard Deviation 5.58 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (0.5 hr) | 1.74 millimetres of mercury (mmHg) | Standard Deviation 4.85 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (Predose) | -0.77 millimetres of mercury (mmHg) | Standard Deviation 3.11 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Baseline (BL): Absolute Value | 14.69 millimetres of mercury (mmHg) | Standard Deviation 3.85 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Day 1 (0.5 hr) | 1.59 millimetres of mercury (mmHg) | Standard Deviation 4.3 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 1 | -0.62 millimetres of mercury (mmHg) | Standard Deviation 3.35 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (Predose) | -1.18 millimetres of mercury (mmHg) | Standard Deviation 3.85 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (0.5 hr) | 2.05 millimetres of mercury (mmHg) | Standard Deviation 4.26 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (Predose) | -0.69 millimetres of mercury (mmHg) | Standard Deviation 3.07 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (0.5 hr) | 2.37 millimetres of mercury (mmHg) | Standard Deviation 5.15 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (Predose) | -0.82 millimetres of mercury (mmHg) | Standard Deviation 3.37 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (0.5 hr) | 2.59 millimetres of mercury (mmHg) | Standard Deviation 3.95 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 13 | -0.71 millimetres of mercury (mmHg) | Standard Deviation 4.02 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (0.5 hr) | 1.67 millimetres of mercury (mmHg) | Standard Deviation 3.92 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (Predose) | 0.08 millimetres of mercury (mmHg) | Standard Deviation 3.61 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (0.5 hr) | 1.82 millimetres of mercury (mmHg) | Standard Deviation 5.37 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (Predose) | 0.26 millimetres of mercury (mmHg) | Standard Deviation 2.77 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (0.5 hr) | 4.11 millimetres of mercury (mmHg) | Standard Deviation 3.51 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (Predose) | -1.00 millimetres of mercury (mmHg) | Standard Deviation 2.91 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (0.5 hr) | 1.74 millimetres of mercury (mmHg) | Standard Deviation 4.8 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (Predose) | -0.41 millimetres of mercury (mmHg) | Standard Deviation 3.07 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (0.5 hr) | 1.63 millimetres of mercury (mmHg) | Standard Deviation 5.47 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 36 | -0.65 millimetres of mercury (mmHg) | Standard Deviation 3.85 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (0.5 hr) | 0.68 millimetres of mercury (mmHg) | Standard Deviation 5.45 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (Predose) | 0.13 millimetres of mercury (mmHg) | Standard Deviation 2.94 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (Predose) | -0.87 millimetres of mercury (mmHg) | Standard Deviation 2.99 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Baseline (BL): Absolute Value | 14.98 millimetres of mercury (mmHg) | Standard Deviation 2.91 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (0.5 hr) | 2.53 millimetres of mercury (mmHg) | Standard Deviation 3.6 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (Predose) | -0.87 millimetres of mercury (mmHg) | Standard Deviation 2.75 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 36 | -0.20 millimetres of mercury (mmHg) | Standard Deviation 3.55 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 1 | -1.96 millimetres of mercury (mmHg) | Standard Deviation 2.98 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (0.5 hr) | 0.91 millimetres of mercury (mmHg) | Standard Deviation 3.66 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (Predose) | -0.80 millimetres of mercury (mmHg) | Standard Deviation 2.92 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (0.5 hr) | 1.93 millimetres of mercury (mmHg) | Standard Deviation 3.91 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (Predose) | -1.00 millimetres of mercury (mmHg) | Standard Deviation 2.56 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (0.5 hr) | -0.98 millimetres of mercury (mmHg) | Standard Deviation 4.38 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (0.5 hr) | 1.51 millimetres of mercury (mmHg) | Standard Deviation 3.96 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 13 | -1.09 millimetres of mercury (mmHg) | Standard Deviation 2.7 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (Predose) | -0.44 millimetres of mercury (mmHg) | Standard Deviation 3.18 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (0.5 hr) | -0.30 millimetres of mercury (mmHg) | Standard Deviation 3.98 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (Predose) | -0.61 millimetres of mercury (mmHg) | Standard Deviation 2.73 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (Predose) | -0.38 millimetres of mercury (mmHg) | Standard Deviation 2.74 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (0.5 hr) | 2.11 millimetres of mercury (mmHg) | Standard Deviation 4.04 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Day 1 (0.5 hr) | 2.37 millimetres of mercury (mmHg) | Standard Deviation 4.22 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Day 1 (0.5 hr) | 3.52 millimetres of mercury (mmHg) | Standard Deviation 4.79 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (Predose) | -0.17 millimetres of mercury (mmHg) | Standard Deviation 2.71 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (Predose) | 0.45 millimetres of mercury (mmHg) | Standard Deviation 2.45 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 20 (0.5 hr) | 2.62 millimetres of mercury (mmHg) | Standard Deviation 4.54 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (0.5 hr) | 3.93 millimetres of mercury (mmHg) | Standard Deviation 4.52 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (Predose) | 0.14 millimetres of mercury (mmHg) | Standard Deviation 2.73 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 8 (Predose) | 0.10 millimetres of mercury (mmHg) | Standard Deviation 2.64 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (0.5 hr) | 2.37 millimetres of mercury (mmHg) | Standard Deviation 4.97 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 24 (0.5 hr) | 4.17 millimetres of mercury (mmHg) | Standard Deviation 4.28 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (0.5 hr) | 3.59 millimetres of mercury (mmHg) | Standard Deviation 4.39 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Baseline (BL): Absolute Value | 14.27 millimetres of mercury (mmHg) | Standard Deviation 2.8 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (Predose) | -0.19 millimetres of mercury (mmHg) | Standard Deviation 2.89 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 4 (Predose) | 0.59 millimetres of mercury (mmHg) | Standard Deviation 2.49 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 28 (0.5 hr) | 3.86 millimetres of mercury (mmHg) | Standard Deviation 4.49 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 1 | 0.11 millimetres of mercury (mmHg) | Standard Deviation 2.36 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 36 | -0.16 millimetres of mercury (mmHg) | Standard Deviation 3.18 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 32 (Predose) | -0.67 millimetres of mercury (mmHg) | Standard Deviation 3.06 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (Predose) | -0.36 millimetres of mercury (mmHg) | Standard Deviation 2.83 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 13 | -0.65 millimetres of mercury (mmHg) | Standard Deviation 2.75 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 16 (0.5 hr) | 3.12 millimetres of mercury (mmHg) | Standard Deviation 5.27 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants | Change from BL at Week 12 (0.5 hr) | 4.34 millimetres of mercury (mmHg) | Standard Deviation 5.25 |
Secondary
Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Total Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.09 nanograms per millilitre (ng/mL). Plasma total Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Baseline, Weeks 4, 12, 13, 16, 24, and 36
Population: Analysis included all randomized participants who had received study treatment and had evaluable pharmacodynamic samples at a given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 2.14 nanograms per millilitre (ng/mL) | Standard Deviation 1.38 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.08 nanograms per millilitre (ng/mL) | Standard Deviation 0.42 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.00 nanograms per millilitre (ng/mL) | Standard Deviation 0.68 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | 0.10 nanograms per millilitre (ng/mL) | Standard Deviation 0.89 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 0.03 nanograms per millilitre (ng/mL) | Standard Deviation 0.48 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 0.18 nanograms per millilitre (ng/mL) | Standard Deviation 0.91 |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | 0.01 nanograms per millilitre (ng/mL) | Standard Deviation 0.62 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | 0.04 nanograms per millilitre (ng/mL) | Standard Deviation 0.71 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 0.23 nanograms per millilitre (ng/mL) | Standard Deviation 0.35 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 0.09 nanograms per millilitre (ng/mL) | Standard Deviation 0.39 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 1.81 nanograms per millilitre (ng/mL) | Standard Deviation 0.67 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.11 nanograms per millilitre (ng/mL) | Standard Deviation 0.77 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | 0.14 nanograms per millilitre (ng/mL) | Standard Deviation 0.37 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.05 nanograms per millilitre (ng/mL) | Standard Deviation 0.42 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 1.05 nanograms per millilitre (ng/mL) | Standard Deviation 1.15 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 1.86 nanograms per millilitre (ng/mL) | Standard Deviation 1.12 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 0.09 nanograms per millilitre (ng/mL) | Standard Deviation 0.27 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | 0.22 nanograms per millilitre (ng/mL) | Standard Deviation 0.48 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | 0.24 nanograms per millilitre (ng/mL) | Standard Deviation 0.47 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.21 nanograms per millilitre (ng/mL) | Standard Deviation 0.52 |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.25 nanograms per millilitre (ng/mL) | Standard Deviation 0.39 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | 0.19 nanograms per millilitre (ng/mL) | Standard Deviation 0.5 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | 0.22 nanograms per millilitre (ng/mL) | Standard Deviation 0.61 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | 0.20 nanograms per millilitre (ng/mL) | Standard Deviation 0.49 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.33 nanograms per millilitre (ng/mL) | Standard Deviation 0.89 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.24 nanograms per millilitre (ng/mL) | Standard Deviation 0.57 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 1.80 nanograms per millilitre (ng/mL) | Standard Deviation 0.71 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 0.87 nanograms per millilitre (ng/mL) | Standard Deviation 0.76 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 12 | -0.11 nanograms per millilitre (ng/mL) | Standard Deviation 0.49 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 36 | 0.05 nanograms per millilitre (ng/mL) | Standard Deviation 0.56 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 24 | 0.04 nanograms per millilitre (ng/mL) | Standard Deviation 0.44 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 16 | -0.01 nanograms per millilitre (ng/mL) | Standard Deviation 0.52 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 4 | -0.03 nanograms per millilitre (ng/mL) | Standard Deviation 0.38 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Baseline (BL) - Value at Visit | 1.92 nanograms per millilitre (ng/mL) | Standard Deviation 0.95 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants | Change from BL at Week 13 | 0.81 nanograms per millilitre (ng/mL) | Standard Deviation 0.98 |
Secondary
Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by Fundus Fluorescein Angiography (FFA), in Treatment-Naive Participants
The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA). This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Time frame: Baseline, Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by Fundus Fluorescein Angiography (FFA), in Treatment-Naive Participants | -3.41 millimetres squared (mm^2) |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by Fundus Fluorescein Angiography (FFA), in Treatment-Naive Participants | -3.81 millimetres squared (mm^2) |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by Fundus Fluorescein Angiography (FFA), in Treatment-Naive Participants | -3.19 millimetres squared (mm^2) |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by Fundus Fluorescein Angiography (FFA), in Treatment-Naive Participants | -3.31 millimetres squared (mm^2) |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.p-value: 0.671780% CI: [-1.61, 0.81]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.p-value: 0.813180% CI: [-1.01, 1.47]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between each of the treatment groups (Arms B, C, or D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arms B, C, or D means were different from Arm A mean.p-value: 0.906980% CI: [-1.07, 1.29]Mixed Model for Repeated Measures
Secondary
Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Treatment-Naive Participants
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). This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Time frame: Baseline, Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Treatment-Naive Participants | -4.18 millimetres squared (mm^2) |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Treatment-Naive Participants | -5.14 millimetres squared (mm^2) |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Treatment-Naive Participants | -2.96 millimetres squared (mm^2) |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Treatment-Naive Participants | -3.83 millimetres squared (mm^2) |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.p-value: 0.318980% CI: [-2.2, 0.28]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.p-value: 0.225680% CI: [-0.07, 2.52]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.p-value: 0.708680% CI: [-0.86, 1.57]Mixed Model for Repeated Measures
Secondary
Mean Change From Baseline in Total Area of Leakage at Week 36, as Measured by FFA, in Treatment-Naive Participants
The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA). This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Time frame: Baseline, Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Baseline in Total Area of Leakage at Week 36, as Measured by FFA, in Treatment-Naive Participants | -5.15 millimetres squared (mm^2) |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Baseline in Total Area of Leakage at Week 36, as Measured by FFA, in Treatment-Naive Participants | -5.94 millimetres squared (mm^2) |
| Arm C: Faricimab, 6 mg Q4W | Mean Change From Baseline in Total Area of Leakage at Week 36, as Measured by FFA, in Treatment-Naive Participants | -3.71 millimetres squared (mm^2) |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Change From Baseline in Total Area of Leakage at Week 36, as Measured by FFA, in Treatment-Naive Participants | -4.66 millimetres squared (mm^2) |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.p-value: 0.435380% CI: [-2.07, 0.51]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.p-value: 0.165280% CI: [0.11, 2.78]Mixed Model for Repeated Measures
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.p-value: 0.6111180% CI: [-0.76, 1.75]Mixed Model for Repeated Measures
Secondary
Mean Change From Week 12 in Central Subfield Thickness at Week 36, as Measured by SD-OCT in Anti-VEGF Incomplete Responders
Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Time frame: Weeks 12 and 36
Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Week 12 in Central Subfield Thickness at Week 36, as Measured by SD-OCT in Anti-VEGF Incomplete Responders | -17.00 micrometres (μm) |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Week 12 in Central Subfield Thickness at Week 36, as Measured by SD-OCT in Anti-VEGF Incomplete Responders | -31.42 micrometres (μm) |
Comparison: The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.p-value: 0.208980% CI: [-29.1, 0.29]Mixed Model for Repeated Measures
Secondary
Mean Change From Week 12 in Foveal Center Point Thickness at Week 36, as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Foveal center point thickness (FCPT) is 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. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Time frame: Weeks 12 and 36
Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Week 12 in Foveal Center Point Thickness at Week 36, as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | -14.5 micrometres (μm) |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Week 12 in Foveal Center Point Thickness at Week 36, as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | -20.8 micrometres (μm) |
Comparison: The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.p-value: 0.518580% CI: [-19, 6.27]Mixed Model for Repeated Measures
Secondary
Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders
The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Time frame: Weeks 12 and 36
Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Weeks 12 and 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders | -0.50 millimetres squared (mm^2) | Standard Deviation 2.37 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders | -1.37 millimetres squared (mm^2) | Standard Deviation 3.72 |
Secondary
Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders
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: Weeks 12 and 36
Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Weeks 12 and 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders | -1.87 millimetres squared (mm^2) | Standard Deviation 4.05 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders | -1.88 millimetres squared (mm^2) | Standard Deviation 3.98 |
Secondary
Mean Change From Week 12 in Total Area of Leakage at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders
The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Time frame: Weeks 12 and 36
Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Weeks 12 and 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Mean Change From Week 12 in Total Area of Leakage at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders | -1.87 millimetres squared (mm^2) | Standard Deviation 4.05 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Change From Week 12 in Total Area of Leakage at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders | -2.00 millimetres squared (mm^2) | Standard Deviation 3.98 |
Secondary
Mean Plasma Concentration of Faricimab Over Time, in All Participants
Plasma concentrations of faricimab were measured by a specific validated enzyme-linked immunoabsorbent assay (ELISA) only from samples of participants randomized to receive faricimab. Baseline was defined as the last non-missing predose assessment. The lower limit of quantification (LLOQ) for the faricimab assay was 0.800 nanograms per millilitre (ng/mL). Values below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Predose (on days when treatment was administered) at Baseline and Weeks 4, 12, 13, 16, 24, and 36
Population: Analysis included all randomized participants who had received treatment with faricimab (i.e., excludes Arm A at all timepoints and Arm E at Week 4) and had evaluable pharmacokinetic samples at a given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm B: Faricimab, 1.5 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Baseline | 0.40 nanograms per millilitre (ng/mL) | Standard Deviation 0 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 16 | 9.52 nanograms per millilitre (ng/mL) | Standard Deviation 7.41 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 4 | 8.83 nanograms per millilitre (ng/mL) | Standard Deviation 5.85 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 24 | 9.07 nanograms per millilitre (ng/mL) | Standard Deviation 7.39 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 12 | 18.68 nanograms per millilitre (ng/mL) | Standard Deviation 24.38 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 36 | 10.65 nanograms per millilitre (ng/mL) | Standard Deviation 8.47 |
| Arm B: Faricimab, 1.5 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 13 | 43.32 nanograms per millilitre (ng/mL) | Standard Deviation 31.98 |
| Arm C: Faricimab, 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 24 | 35.30 nanograms per millilitre (ng/mL) | Standard Deviation 22.03 |
| Arm C: Faricimab, 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 12 | 57.92 nanograms per millilitre (ng/mL) | Standard Deviation 57.65 |
| Arm C: Faricimab, 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 16 | 46.99 nanograms per millilitre (ng/mL) | Standard Deviation 35.19 |
| Arm C: Faricimab, 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 36 | 36.43 nanograms per millilitre (ng/mL) | Standard Deviation 30.8 |
| Arm C: Faricimab, 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 13 | 184.38 nanograms per millilitre (ng/mL) | Standard Deviation 102.01 |
| Arm C: Faricimab, 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 4 | 31.06 nanograms per millilitre (ng/mL) | Standard Deviation 18.47 |
| Arm C: Faricimab, 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Baseline | 0.40 nanograms per millilitre (ng/mL) | Standard Deviation 0 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 13 | 178.25 nanograms per millilitre (ng/mL) | Standard Deviation 119.98 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Baseline | 0.40 nanograms per millilitre (ng/mL) | Standard Deviation 0 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 4 | 36.58 nanograms per millilitre (ng/mL) | Standard Deviation 19.78 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 12 | 57.94 nanograms per millilitre (ng/mL) | Standard Deviation 73.91 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 16 | 43.54 nanograms per millilitre (ng/mL) | Standard Deviation 39.05 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 24 | 31.19 nanograms per millilitre (ng/mL) | Standard Deviation 24.13 |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 36 | 4.69 nanograms per millilitre (ng/mL) | Standard Deviation 7.24 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 36 | 36.06 nanograms per millilitre (ng/mL) | Standard Deviation 26.93 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 24 | 37.80 nanograms per millilitre (ng/mL) | Standard Deviation 27.75 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 12 | 45.29 nanograms per millilitre (ng/mL) | Standard Deviation 105.64 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Baseline | 0.47 nanograms per millilitre (ng/mL) | Standard Deviation 0.59 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 16 | 44.71 nanograms per millilitre (ng/mL) | Standard Deviation 50.55 |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Mean Plasma Concentration of Faricimab Over Time, in All Participants | Week 13 | 160.52 nanograms per millilitre (ng/mL) | Standard Deviation 124.73 |
Secondary
Number of Participants With Abnormal Body Temperature, in All Participants
Abnormal body temperature (supine) was defined as any value outside of the standard reference range, from \<36.5 (low) to \>37.5 (high) degrees Celsius. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Time frame: Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment. In this analysis, the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Abnormal Body Temperature, in All Participants | High | 4 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Abnormal Body Temperature, in All Participants | Low | 28 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Abnormal Body Temperature, in All Participants | High | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Abnormal Body Temperature, in All Participants | Low | 19 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Abnormal Body Temperature, in All Participants | High | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Abnormal Body Temperature, in All Participants | Low | 14 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Abnormal Body Temperature, in All Participants | Low | 25 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Abnormal Body Temperature, in All Participants | High | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Abnormal Body Temperature, in All Participants | High | 6 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Abnormal Body Temperature, in All Participants | Low | 29 Participants |
Secondary
Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants
Abnormal diastolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<40 (low) to \>90 (high) millimetres of mercury (mmHg). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Time frame: Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment. In this analysis, the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | High | 15 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | High | 9 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | High | 8 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | High | 10 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants | High | 9 Participants |
Secondary
Number of Participants With Abnormal Heart Rate, in All Participants
Abnormal heart rate (supine) was defined as any value outside of the standard reference range, from \<40 (low) to \>100 (high) beats per minute. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Time frame: Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment. In this analysis, the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Abnormal Heart Rate, in All Participants | Low | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Abnormal Heart Rate, in All Participants | High | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Abnormal Heart Rate, in All Participants | Low | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Abnormal Heart Rate, in All Participants | High | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Abnormal Heart Rate, in All Participants | Low | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Abnormal Heart Rate, in All Participants | High | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Abnormal Heart Rate, in All Participants | High | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Abnormal Heart Rate, in All Participants | Low | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Abnormal Heart Rate, in All Participants | Low | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Abnormal Heart Rate, in All Participants | High | 1 Participants |
Secondary
Number of Participants With Abnormal Systolic Blood Pressure, in All Participants
Abnormal systolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<70 (low) to \>140 (high) millimetres of mercury (mmHg). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Time frame: Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment. In this analysis, the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | High | 20 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | High | 13 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | High | 13 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | High | 23 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | Low | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Abnormal Systolic Blood Pressure, in All Participants | High | 25 Participants |
Secondary
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants
The investigator assessed adverse event severity 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. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.
Time frame: From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Adverse Event (AE) of Any Grade | 28 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Mild AE | 27 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Moderate AE | 4 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Severe AE | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - AE of Any Grade | 21 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Mild AE | 15 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Moderate AE | 5 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Severe AE | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Moderate AE | 2 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Mild AE | 14 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Adverse Event (AE) of Any Grade | 21 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Severe AE | 3 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Mild AE | 19 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Severe AE | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - AE of Any Grade | 16 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Moderate AE | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Moderate AE | 4 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Severe AE | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Severe AE | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Mild AE | 7 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Moderate AE | 3 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Mild AE | 20 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Adverse Event (AE) of Any Grade | 21 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - AE of Any Grade | 9 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Mild AE | 25 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Moderate AE | 6 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Severe AE | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - AE of Any Grade | 18 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Mild AE | 17 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Severe AE | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Adverse Event (AE) of Any Grade | 27 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Moderate AE | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Severe AE | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Severe AE | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Moderate AE | 8 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Moderate AE | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Adverse Event (AE) of Any Grade | 28 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - Mild AE | 17 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Study Eye - Mild AE | 24 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants | Fellow Eye - AE of Any Grade | 20 Participants |
Secondary
Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants
The investigator assessed adverse event severity 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. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.
Time frame: From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Any Grade | 37 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Mild | 30 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Moderate | 16 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Severe | 7 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Any Grade | 37 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Severe | 2 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Mild | 27 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Moderate | 18 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Severe | 5 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Mild | 17 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Moderate | 14 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Any Grade | 23 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Any Grade | 30 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Mild | 23 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Severe | 4 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Moderate | 13 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Severe | 4 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Moderate | 26 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Mild | 28 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants | Any Grade | 43 Participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Clinical laboratory tests for blood chemistry parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. GGT = gamma-glutamyltransferase; SGOT/AST = serum glutamic oxaloacetic transaminase / aspartate aminotransferase; SGPT/ALT = serum glutamic pyruvic transaminase / alanine aminotransferase
Time frame: Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment. This analysis included participants with non-missing assessments.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Any Abnormality | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Last or Replicated | 2 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Last or Replicated | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Any Abnormality | 5 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Single, Not Last | 3 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Last or Replicated | 2 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Last or Replicated | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Single, Not Last | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Any Abnormality | 2 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Last or Replicated | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Any Abnormality | 2 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Single, Not Last | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Any Abnormality | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Any Abnormality | 2 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Any Abnormality | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Single, Not Last | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Last or Replicated | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Single, Not Last | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Last or Replicated | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Single, Not Last | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Any Abnormality | 3 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Last or Replicated | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Single, Not Last | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Last or Replicated | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Single, Not Last | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Any Abnormality | 3 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Last or Replicated | 2 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Single, Not Last | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Last or Replicated | 3 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Any Abnormality | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Single, Not Last | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Any Abnormality | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Single, Not Last | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Any Abnormality | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Last or Replicated | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Any Abnormality | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Last or Replicated | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Any Abnormality | 2 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Single, Not Last | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Last or Replicated | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Any Abnormality | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Single, Not Last | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Any Abnormality | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Single, Not Last | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Single, Not Last | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Last or Replicated | 3 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Any Abnormality | 3 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Single, Not Last | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Any Abnormality | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Last or Replicated | 2 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Any Abnormality | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Single, Not Last | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Any Abnormality | 3 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Any Abnormality | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Last or Replicated | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Last or Replicated | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Any Abnormality | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, Low - Last or Replicated | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Any Abnormality | 5 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Single, Not Last | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Single, Not Last | 3 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, High - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Phosphorus, High - Last or Replicated | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Calcium, Low - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Potassium, High - Last or Replicated | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Last or Replicated | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Single, Not Last | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), High - Any Abnormality | 4 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Protein, Total, High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Last or Replicated | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGPT/ALT, High - Single, Not Last | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Alkaline Phosphatase, High - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatinine, High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Last or Replicated | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | SGOT/AST, High - Single, Not Last | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Single, Not Last | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Bicarbonate (CO2), Low - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | GGT, High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Creatine Kinase, High - Any Abnormality | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants | Chloride, Low - Last or Replicated | 2 Participants |
Secondary
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Clinical laboratory tests for hematology and coagulation parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. Abs. = absolute count; Corp. = corpuscular; Ery. = erythrocyte; INR = International Normalized Ratio
Time frame: Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment. This analysis included participants with non-missing assessments.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Any Abnormality | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Last or Replicated | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Single, Not Last | 2 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Any Abnormality | 3 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Single, Not Last | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Single, Not Last | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High -Last or Replicated | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Single, Not Last | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Any Abnormality | 2 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Any Abnormality | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Single, Not Last | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Any Abnormality | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Last or Replicated | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Single, Not Last | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Single, Not Last | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Single, Not Last | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Any Abnormality | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High -Last or Replicated | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Last or Replicated | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Any Abnormality | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Single, Not Last | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Single, Not Last | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Single, Not Last | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Last or Replicated | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Any Abnormality | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High -Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Any Abnormality | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Any Abnormality | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Last or Replicated | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Single, Not Last | 1 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Any Abnormality | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Last or Replicated | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Any Abnormality | 2 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Single, Not Last | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Last or Replicated | 2 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Any Abnormality | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Single, Not Last | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Last or Replicated | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Any Abnormality | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Any Abnormality | 3 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Last or Replicated | 2 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Last or Replicated | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Single, Not Last | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Last or Replicated | 2 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Single, Not Last | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High -Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Any Abnormality | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Any Abnormality | 2 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Any Abnormality | 3 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Single, Not Last | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Last or Replicated | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Last or Replicated | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Any Abnormality | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Single, Not Last | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Last or Replicated | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Any Abnormality | 2 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Any Abnormality | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Single, Not Last | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Last or Replicated | 2 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Any Abnormality | 1 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Any Abnormality | 2 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., High - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Single, Not Last | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Single, Not Last | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Last or Replicated | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, Low - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Pct., Low - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hematocrit, Low - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Single, Not Last | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High - Any Abnormality | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., High -Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Any Abnormality | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Eosinophils, Abs., High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | INR, High - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Single, Not Last | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Last or Replicated | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Ery. Mean Corp. Volume, Low - Any Abnormality | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | White Blood Cell Count, High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Lymphocytes, Abs., Low - Any Abnormality | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Platelets, Low - Last or Replicated | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Basophils, Abs., High - Last or Replicated | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Hemoglobin, Low - Single, Not Last | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants | Neutrophils, Total, Abs., Low - Single, Not Last | 0 Participants |
Secondary
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
The presence of cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid, 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. Intraretinal fluid was defined as the presence of fluid within the retina. Pigment epithelial detachment was defined as the presence of a detachment of the pigment epithelium from the Bruch's membrane. 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.
Time frame: Weeks 12 and 36
Population: Anti-VEGF incomplete responders, consisting of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with ≥1 letter increase from Baseline. Analysis only included those with presence of individual dry retina measures (cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid) at Week 12 and reassessed at Week 36.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Cysts: Present at Week 12 | 9 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Cysts: Present at Week 36 | 4 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Cysts: Absent at Week 36 | 5 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Intraretinal Fluid: Present at Week 12 | 28 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Intraretinal Fluid: Present at Week 36 | 19 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Intraretinal Fluid: Absent at Week 36 | 7 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Pigment Epithelial Detachment: Present at Week 12 | 24 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Pigment Epithelial Detachment: Present at Week 36 | 19 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Pigment Epithelial Detachment: Absent at Week 36 | 3 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Subretinal Fluid: Present at Week 12 | 10 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Subretinal Fluid: Present at Week 36 | 3 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Subretinal Fluid: Absent at Week 36 | 5 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Subretinal Fluid: Present at Week 36 | 2 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Cysts: Present at Week 12 | 11 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Pigment Epithelial Detachment: Present at Week 12 | 28 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Cysts: Present at Week 36 | 5 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Subretinal Fluid: Present at Week 12 | 9 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Cysts: Absent at Week 36 | 6 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Pigment Epithelial Detachment: Present at Week 36 | 22 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Intraretinal Fluid: Present at Week 12 | 36 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Subretinal Fluid: Absent at Week 36 | 6 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Intraretinal Fluid: Present at Week 36 | 28 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Pigment Epithelial Detachment: Absent at Week 36 | 5 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders | Intraretinal Fluid: Absent at Week 36 | 7 Participants |
Secondary
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
The presence of cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid, 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. Intraretinal fluid was defined as the presence of fluid within the retina. Pigment epithelial detachment was defined as the presence of a detachment of the pigment epithelium from the Bruch's membrane. 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.
Time frame: Baseline, Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D. This analysis only included participants with presence of the individual dry retina measures (cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid) at Baseline and who were reassessed at Week 36.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Present at Baseline | 56 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Absent at Week 36 | 42 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Present at Week 36 | 43 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Present at Baseline | 52 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Absent at Week 36 | 12 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Absent at Week 36 | 36 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Present at Baseline | 67 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Present at Week 36 | 13 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Present at Week 36 | 11 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Present at Week 36 | 46 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Absent at Week 36 | 18 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Present at Baseline | 58 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Present at Week 36 | 7 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Present at Baseline | 37 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Present at Baseline | 46 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Absent at Week 36 | 6 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Present at Baseline | 41 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Present at Week 36 | 25 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Present at Baseline | 29 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Absent at Week 36 | 13 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Present at Week 36 | 27 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Absent at Week 36 | 18 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Absent at Week 36 | 18 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Present at Week 36 | 18 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Present at Week 36 | 20 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Present at Baseline | 29 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Present at Week 36 | 6 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Absent at Week 36 | 21 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Present at Baseline | 39 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Present at Week 36 | 28 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Absent at Week 36 | 9 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Present at Baseline | 27 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Absent at Week 36 | 6 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Present at Baseline | 30 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Present at Week 36 | 3 Participants |
| Arm C: Faricimab, 6 mg Q4W | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Absent at Week 36 | 26 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Absent at Week 36 | 9 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Present at Week 36 | 34 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Present at Baseline | 38 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Present at Baseline | 35 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Intraretinal Fluid: Present at Baseline | 45 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Absent at Week 36 | 25 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Absent at Week 36 | 25 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Subretinal Fluid: Present at Week 36 | 8 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Present at Week 36 | 32 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Present at Baseline | 36 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Cysts: Present at Week 36 | 11 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants | Pigment Epithelial Detachment: Absent at Week 36 | 4 Participants |
Secondary
Percentage of Participants Gaining ≥15 Letters From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders
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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Weeks 12 and 36
Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Weeks 12 and 36.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Percentage of Participants Gaining ≥15 Letters From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders | 5.71 Percentage of Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Percentage of Participants Gaining ≥15 Letters From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders | 0.00 Percentage of Participants |
Comparison: The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.p-value: 0.232880% CI: [-10.74, -0.69]Fisher Exact
Secondary
Percentage of Participants Gaining Greater Than or Equal to (≥) 15 Letters From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants
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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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 outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Baseline, Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Percentage of Participants Gaining Greater Than or Equal to (≥) 15 Letters From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | 31.0 Percentage of Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Percentage of Participants Gaining Greater Than or Equal to (≥) 15 Letters From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | 36.6 Percentage of Participants |
| Arm C: Faricimab, 6 mg Q4W | Percentage of Participants Gaining Greater Than or Equal to (≥) 15 Letters From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | 27.9 Percentage of Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Percentage of Participants Gaining Greater Than or Equal to (≥) 15 Letters From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants | 23.7 Percentage of Participants |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.p-value: 0.552780% CI: [-6.52, 17.77]Generalized Estimating Equations Model
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.p-value: 0.738280% CI: [-14.95, 8.76]Generalized Estimating Equations Model
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.p-value: 0.393280% CI: [-18.32, 3.67]Generalized Estimating Equations Model
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Anti-VEGF Incomplete Responders
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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 36
Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Week 36.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Anti-VEGF Incomplete Responders | 14.29 Percentage of Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Anti-VEGF Incomplete Responders | 13.51 Percentage of Participants |
Comparison: The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.p-value: 180% CI: [-11.23, 9.68]Fisher Exact
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Treatment-Naive Participants
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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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 outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Treatment-Naive Participants | 7.7 Percentage of Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Treatment-Naive Participants | 8.7 Percentage of Participants |
| Arm C: Faricimab, 6 mg Q4W | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Treatment-Naive Participants | 15.8 Percentage of Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Treatment-Naive Participants | 8.8 Percentage of Participants |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.p-value: 0.853680% CI: [-5.93, 7.93]Generalized Estimating Equations Model
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.p-value: 0.230380% CI: [-0.56, 16.83]Generalized Estimating Equations Model
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.p-value: 0.840680% CI: [-5.79, 7.95]Generalized Estimating Equations Model
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Anti-VEGF Incomplete Responders
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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 36
Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Week 36.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Anti-VEGF Incomplete Responders | 22.86 Percentage of Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Anti-VEGF Incomplete Responders | 16.22 Percentage of Participants |
Comparison: The null hypothesis (Ho) was that there was no difference between the treatment group (Arm E) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm E was different from Arm A.p-value: 0.558680% CI: [-18.6, 5.32]Fisher Exact
Secondary
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Treatment-Naive Participants
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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's 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 outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 36
Population: Treatment-naive participants randomized to Arms A, B, C, and D.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Treatment-Naive Participants | 49.5 Percentage of Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Treatment-Naive Participants | 49.0 Percentage of Participants |
| Arm C: Faricimab, 6 mg Q4W | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Treatment-Naive Participants | 39.4 Percentage of Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Treatment-Naive Participants | 41.8 Percentage of Participants |
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm B) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm B mean was different from Arm A mean.p-value: 0.958180% CI: [-13.26, 12.22]Generalized Estimating Equations Model
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm C) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm C mean was different from Arm A mean.p-value: 0.316680% CI: [-22.99, 2.82]Generalized Estimating Equations Model
Comparison: The null hypothesis (Ho) was that there was no difference in means between the treatment group (Arm D) and the control group (Arm A). The alternative hypothesis (Ha) was that Arm D mean was different from Arm A mean.p-value: 0.424480% CI: [-20.01, 4.64]Generalized Estimating Equations Model
Secondary
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs leading to discontinuation (withdrawal) of treatment with study drug, and AEs with fatal outcome. 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 treatment (up to 36 weeks)
Population: Safety Population: all participants who received at least one dose of study treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE | 37 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Fellow Eye | 21 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Ocular AE in the Study Eye | 3 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Study Eye Leading to Withdrawal | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Ocular AE in the Study Eye | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related AE | 3 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Either Eye | 39 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Adverse Event (AE) | 51 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related Serious AE | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Serious AE | 9 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | AE with Fatal Outcome | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Study Eye | 28 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Systemic AE | 0 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE Leading to Withdrawal | 1 Participants |
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Systemic AE | 9 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related Serious AE | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Adverse Event (AE) | 39 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Either Eye | 25 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Study Eye | 21 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Fellow Eye | 16 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Ocular AE in the Study Eye | 3 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Study Eye Leading to Withdrawal | 1 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE | 37 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Systemic AE | 7 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE Leading to Withdrawal | 2 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | AE with Fatal Outcome | 0 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Serious AE | 11 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related AE | 4 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Ocular AE in the Study Eye | 4 Participants |
| Arm B: Faricimab, 1.5 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Systemic AE | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Systemic AE | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related Serious AE | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Adverse Event (AE) | 31 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | AE with Fatal Outcome | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Ocular AE in the Study Eye | 3 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Either Eye | 23 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE | 23 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Serious AE | 7 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Systemic AE | 7 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Study Eye Leading to Withdrawal | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Ocular AE in the Study Eye | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Study Eye | 21 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related AE | 3 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE Leading to Withdrawal | 0 Participants |
| Arm C: Faricimab, 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Fellow Eye | 9 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Study Eye Leading to Withdrawal | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE | 30 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Study Eye | 27 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Ocular AE in the Study Eye | 3 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Systemic AE | 4 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE Leading to Withdrawal | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | AE with Fatal Outcome | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Either Eye | 29 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Serious AE | 5 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related Serious AE | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related AE | 3 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Fellow Eye | 18 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Adverse Event (AE) | 39 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Ocular AE in the Study Eye | 0 Participants |
| Arm D: Faricimab, 6 mg Every 4-8 Weeks | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Systemic AE | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Adverse Event (AE) | 54 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE Leading to Withdrawal | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Ocular AE in the Study Eye | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Ocular AE in the Study Eye | 2 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related AE | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Fellow Eye | 20 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Systemic AE | 43 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Study Eye Leading to Withdrawal | 4 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Serious Systemic AE | 6 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Serious AE | 8 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | AE with Fatal Outcome | 1 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Related Systemic AE | 0 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in Either Eye | 37 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Ocular AE in the Study Eye | 28 Participants |
| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants | Any Related Serious AE | 0 Participants |