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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W) | Active Comparator | Participants will receive ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) Q4W up to Week 32 (total 9 injections). The final study visit will take place at Week 36. |
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| Arm B: Faricimab, 1.5 mg Q4W | Experimental | Participants will receive faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit will take place at Week 36. |
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| Arm C: Faricimab, 6 mg Q4W | Experimental | Participants will receive faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit will take place at Week 36. |
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| Arm D: Faricimab, 6 mg Every 4-8 weeks | Experimental | Participants will receive 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 will take place at Week 36. |
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| Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W | Experimental | Participants will receive 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 will take place at Week 36. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Faricimab | Drug | Faricimab will be administered as per the regimen specified in the individual arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 36 |
| 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. | Weeks 12 and 36 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retina Consultants | Phoenix | Arizona | 85020 | United States | ||
| Retinal Consultants of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37868796 | Derived | Kikuchi Y, Kawczynski MG, Anegondi N, Neubert A, Dai J, Ferrara D, Quezada-Ruiz C. Machine Learning to Predict Faricimab Treatment Outcome in Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2023 Aug 18;4(2):100385. doi: 10.1016/j.xops.2023.100385. eCollection 2024 Mar-Apr. | |
| 37422192 | Derived | Yu S, Bachmeier I, Hernandez-Sanchez J, Garcia Armendariz B, Ebneter A, Pauleikhoff D, Chakravarthy U, Fauser S. Hyperreflective Material Boundary Remodeling in Neovascular Age-Related Macular Degeneration: A Post Hoc Analysis of the AVENUE Trial. Ophthalmol Retina. 2023 Nov;7(11):990-998. doi: 10.1016/j.oret.2023.06.024. Epub 2023 Jul 6. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Arm B: Faricimab, 1.5 mg Q4W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2016 | Sep 16, 2020 |
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| Ranibizumab | Drug | Ranibizumab will be administered as per the regimen specified in the individual arm. |
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| Sham Procedure | Drug | 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. |
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| Baseline, Week 36 |
| 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. | Weeks 12 and 36 |
| 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. | Week 36 |
| 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. | Week 36 |
| 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. | Week 36 |
| 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. | Week 36 |
| 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. | Baseline, Week 36 |
| 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. | Weeks 12 and 36 |
| 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. | Baseline, Week 36 |
| 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. | Weeks 12 and 36 |
| 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. | Baseline, Week 36 |
| 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. | Weeks 12 and 36 |
| 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. | Baseline, Week 36 |
| 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). | Weeks 12 and 36 |
| 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. | Baseline, Week 36 |
| 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). | Weeks 12 and 36 |
| 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. | Baseline, Week 36 |
| 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). | Weeks 12 and 36 |
| 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. | From Baseline until 28 days after the last dose of study treatment (up to 36 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 | 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. | From Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| 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. | From Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| 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. | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| 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. | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| 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. | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| 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. | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| 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 | Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks) |
| 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 | Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks) |
| 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. | 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 |
| 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). | Baseline, Predose (0 hour) on Days 1, 28, 84, 112, 168, and 252 or early termination (up to 36 weeks) |
| 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. | Predose (on days when treatment was administered) at Baseline and Weeks 4, 12, 13, 16, 24, and 36 |
| 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. | Baseline, Weeks 4, 12, 13, 16, 24, and 36 |
| 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. | Baseline, Weeks 4, 12, 13, 16, 24, and 36 |
| 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. | Baseline, Weeks 4, 12, 13, 16, 24, and 36 |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| California Retina Consultants | Bakersfield | California | 93309 | United States |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| The Retina Partners | Encino | California | 91436 | United States |
| Retina Consultants, San Diego | Poway | California | 92064 | United States |
| Orange County Retina Med Group | Santa Ana | California | 92705 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| American Institute of Research | Whittier | California | 90603 | United States |
| Retina Consultants of Southern | Colorado Springs | Colorado | 80909 | United States |
| Colorado Retina Associates, PC | Golden | Colorado | 80401 | United States |
| New England Retina Associates | Hamden | Connecticut | 06518 | United States |
| Retina Health Center | Fort Myers | Florida | 33907 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Central Florida Retina | Orlando | Florida | 32806 | United States |
| Retina Care Specialists | Palm Beach Gardens | Florida | 33410 | United States |
| Retina Vitreous Assoc of FL | St. Petersburg | Florida | 33711 | United States |
| Southern Vitreoretinal Assoc | Tallahassee | Florida | 32308 | United States |
| Southeast Retina Center | Augusta | Georgia | 30909 | United States |
| Georgia Retina PC | Marietta | Georgia | 30060 | United States |
| Midwest Eye Institute Northside | Indianapolis | Indiana | 46290 | United States |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | United States |
| Retina Group of Washington | Chevy Chase | Maryland | 20815 | United States |
| National Retina Institute | Towson | Maryland | 21204 | United States |
| Vitreo-Retinal Associates, PC | Worcester | Massachusetts | 01605 | United States |
| Vitreoretinal Surgery | Edina | Minnesota | 55435 | United States |
| Retina Associates of NJ | Toms River | New Jersey | 08755 | United States |
| Eye Associates of New Mexico | Albuquerque | New Mexico | 87102 | United States |
| Long Is. Vitreoretinal Consult | Great Neck | New York | 11021 | United States |
| Opthalmic Consultants of LI | Lynbrook | New York | 11563 | United States |
| Retina Assoc of Western NY | Rochester | New York | 14620 | United States |
| The Retina Consultants | Slingerlands | New York | 12159 | United States |
| Western Carolina Retinal Associate PA | Asheville | North Carolina | 28803 | United States |
| Char Eye Ear &Throat Assoc | Charlotte | North Carolina | 28210 | United States |
| OSU Eye Physicians & Surgeons | Columbus | Ohio | 43212 | United States |
| Oregon Retina, LLP | Eugene | Oregon | 97401 | United States |
| Oregon Retina institute | Medford | Oregon | 97504 | United States |
| Retina Northwest | Portland | Oregon | 97221 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| Southeastern Retina Associates Chattanooga | Chattanooga | Tennessee | 37421 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Tennessee Retina PC. | Nashville | Tennessee | 37203 | United States |
| W Texas Retina Consultants PA | Abilene | Texas | 79606 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | United States |
| Retina Associates of Utah | Salt Lake City | Utah | 84107 | United States |
| Univ of Virginia Ophthalmology | Charlottesville | Virginia | 22903 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| 34201045 | Derived | Maunz A, Benmansour F, Li Y, Albrecht T, Zhang YP, Arcadu F, Zheng Y, Madhusudhan S, Sahni J. Accuracy of a Machine-Learning Algorithm for Detecting and Classifying Choroidal Neovascularization on Spectral-Domain Optical Coherence Tomography. J Pers Med. 2021 Jun 8;11(6):524. doi: 10.3390/jpm11060524. |
| 32729888 | Derived | Sahni J, Dugel PU, Patel SS, Chittum ME, Berger B, Del Valle Rubido M, Sadikhov S, Szczesny P, Schwab D, Nogoceke E, Weikert R, Fauser S. Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):955-963. doi: 10.1001/jamaophthalmol.2020.2685. |
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Received at Least One Dose of Study Drug | Safety Population |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Best-Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Baseline | Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R). The BCVA letter score for each participant ranges from 0 to 100 letters (best score attainable) correctly read on the acuity charts. | Mean | Standard Deviation | BCVA Letters |
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| Best-Corrected Visual Acuity (BCVA) Letter Score Category in the Study Eye at Baseline | Count of Participants | Participants |
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| Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline | Count of Participants | Participants |
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| Presence or Absence of Retinal Angiomatous Proliferation (RAP) in the Study Eye at Baseline | Count of Participants | Participants |
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| Presence or Absence of Polypoidal Choroidal Vasculopathy (PCV) in the Study Eye at Baseline | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Treatment-naive participants randomized to Arms A, B, C, and D. | Posted | Least Squares Mean | 80% Confidence Interval | BCVA Letters | Baseline, Week 36 |
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| 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. | 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. | Posted | Least Squares Mean | 80% Confidence Interval | BCVA Letters | Weeks 12 and 36 |
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| 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. | Treatment-naive participants randomized to Arms A, B, C, and D. | Posted | Least Squares Mean | 80% Confidence Interval | Percentage of Participants | Baseline, Week 36 |
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| 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. | 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. | Posted | Number | 80% Confidence Interval | Percentage of Participants | Weeks 12 and 36 |
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| 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. | Treatment-naive participants randomized to Arms A, B, C, and D. | Posted | Least Squares Mean | 80% Confidence Interval | Percentage of Participants | Week 36 |
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| 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. | 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. | Posted | Number | 80% Confidence Interval | Percentage of Participants | Week 36 |
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| 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. | Treatment-naive participants randomized to Arms A, B, C, and D. | Posted | Least Squares Mean | 80% Confidence Interval | Percentage of Participants | Week 36 |
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| 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. | 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. | Posted | Number | 80% Confidence Interval | Percentage of Participants | Week 36 |
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| 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. | Treatment-naive participants randomized to Arms A, B, C, and D. | Posted | Least Squares Mean | 80% Confidence Interval | micrometres (μm) | Baseline, Week 36 |
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| 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. | 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. | Posted | Least Squares Mean | 80% Confidence Interval | micrometres (μm) | Weeks 12 and 36 |
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| 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. | Treatment-naive participants randomized to Arms A, B, C, and D. | Posted | Least Squares Mean | 80% Confidence Interval | micrometres (μm) | Baseline, Week 36 |
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| 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. | 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. | Posted | Least Squares Mean | 80% Confidence Interval | micrometres (μm) | Weeks 12 and 36 |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Week 36 |
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| 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. | 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. | Posted | Count of Participants | Participants | Weeks 12 and 36 |
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| 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. | Treatment-naive participants randomized to Arms A, B, C, and D. | Posted | Least Squares Mean | 80% Confidence Interval | millimetres squared (mm^2) | Baseline, Week 36 |
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| 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). | 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. | Posted | Mean | Standard Deviation | millimetres squared (mm^2) | Weeks 12 and 36 |
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| 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. | Treatment-naive participants randomized to Arms A, B, C, and D. | Posted | Least Squares Mean | 80% Confidence Interval | millimetres squared (mm^2) | Baseline, Week 36 |
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| 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). | 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. | Posted | Mean | Standard Deviation | millimetres squared (mm^2) | Weeks 12 and 36 |
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| 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. | Treatment-naive participants randomized to Arms A, B, C, and D. | Posted | Least Squares Mean | 80% Confidence Interval | millimetres squared (mm^2) | Baseline, Week 36 |
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| 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). | 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. | Posted | Mean | Standard Deviation | millimetres squared (mm^2) | Weeks 12 and 36 |
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| 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. | Safety Population: all participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | From Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
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| 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. | Safety Population: all participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | From Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
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| 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. | Safety Population: all participants who received at least one dose of study treatment | Posted | Count of Participants | Participants | From Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
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| 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. | 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. | Posted | Count of Participants | Participants | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Safety Population: all participants who received at least one dose of study treatment. This analysis included participants with non-missing assessments. | Posted | Count of Participants | Participants | Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Safety Population: all participants who received at least one dose of study treatment. This analysis included participants with non-missing assessments. | Posted | Count of Participants | Participants | Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety Population: all participants who received at least one dose of study treatment | Posted | Mean | Standard Deviation | millimetres of mercury (mmHg) | 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 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Count of Participants | Participants | Baseline, Predose (0 hour) on Days 1, 28, 84, 112, 168, and 252 or early termination (up to 36 weeks) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | nanograms per millilitre (ng/mL) | Predose (on days when treatment was administered) at Baseline and Weeks 4, 12, 13, 16, 24, and 36 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Analysis included all randomized participants who had received study treatment and had evaluable pharmacodynamic samples at a given timepoint. | Posted | Mean | Standard Deviation | picograms per millilitre (pg/mL) | Baseline, Weeks 4, 12, 13, 16, 24, and 36 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Analysis included all randomized participants who had received study treatment and had evaluable pharmacodynamic samples at a given timepoint. | Posted | Mean | Standard Deviation | nanograms per millilitre (ng/mL) | Baseline, Weeks 4, 12, 13, 16, 24, and 36 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Analysis included all randomized participants who had received study treatment and had evaluable pharmacodynamic samples at a given timepoint. | Posted | Mean | Standard Deviation | nanograms per millilitre (ng/mL) | Baseline, Weeks 4, 12, 13, 16, 24, and 36 |
|
From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 67 | 9 | 67 | 39 | 67 |
| EG001 | 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. | 0 | 46 | 11 | 46 | 31 | 46 |
| EG002 | 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. | 0 | 39 | 7 | 39 | 24 | 39 |
| EG003 | 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. | 0 | 46 | 5 | 46 | 32 | 46 |
| EG004 | 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. | 1 | 64 | 8 | 64 | 40 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Degenerative mitral valve disease | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Keratic Precipitates | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Arteriogram coronary | Investigations | MedDRA version 20.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
| |
| Spindle cell sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Pulmonary resection | Surgical and medical procedures | MedDRA version 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA version 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber cell | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Dry age-related macular degeneration | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Posterior capsule opacification | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Punctate keratitis | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Retinal pigment epithelial tear | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 20.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Anterior chamber flare | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA version 20.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 20.1 | Systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA version 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 20.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | Systematic Assessment |
|
The small number of participants per cohort only allows detection of large differences in outcomes; not designed to show noninferiority of faricimab relative to ranibizumab. The short duration further limits information on long-term visual potential.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2017 | Sep 16, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723200 | faricimab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| BCVA Letter Score >54 |
|
| Assessment Missing |
|
| Classic CNV |
|
| Occult CNV |
|
| Assessment Missing |
|
| RAP Present |
|
| Assessment Missing |
|
| PCV Present |
|
| Assessment Missing |
|
| Superiority |
| 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. | Mixed Model for Repeated Measures | Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, & visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov | 0.5308 | The threshold for statistical significance was an unadjusted 2-sided p-value <0.2. There was no formal correction for multiple comparisons. | Difference in Least Squares Means | -1.59 | 2-Sided | 80 | -4.86 | 1.67 | The mean difference was calculated as Arm C minus Arm A. | Superiority |
| 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. | Mixed Model for Repeated Measures | Categorical covariates(cov): RAP/PCV at baseline(BL), treatment group, visit, & visit by treatment group; Continuous cov: BCVA at BL; Unstructured cov | 0.5309 | The threshold for statistical significance was an unadjusted 2-sided p-value <0.2. There was no formal correction for multiple comparisons. | Difference in Least Squares Means | -1.51 | 2-Sided | 80 | -4.62 | 1.59 | The mean difference was calculated as Arm D minus Arm A. | Superiority |
| 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. |
|
|
|
| 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| OG001 | 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. |
|
|
|
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| OG001 |
| 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. |
|
|
|
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| OG001 |
| 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. |
|
|
|
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36. |
| OG003 | 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. |
|
|
|
|
|
|
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36. |
| OG003 | 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. |
|
|
|
|
|
|
| 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 |
| 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. |
|
|
| OG003 | 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. |
|
|
|
| Participants |
|
|
| OG003 | 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. |
|
|
|
| Counts |
|---|
| Participants |
|
|
| OG003 | 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. |
|
|
|
|
|
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 |
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
|
|
| OG003 | 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. |
| OG004 | 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. |
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