A Phase 2 interventional study of Faricimab and Ranibizumab in Diabetic Macular Edema, sponsored by Hoffmann-La Roche. Completed at 60 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-25.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 229 is above the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
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Exclusion Criteria:
Participants will receive 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.
Drug: Ranibizumab
Participants will receive 1.5 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.
Drug: Faricimab
Participants will receive 6 mg faricimab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.
Drug: Faricimab
Faricimab will be administered by IVT injection in the study eye.
Also known as: RO6867461, RG7716
Ranibizumab will be administered by IVT injection in the study eye.
Also known as: Lucentis
Mean Change From Baseline in BCVA Letter Score at Week 24, 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 primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Baseline, Week 24
Mean Change From Baseline in BCVA Letter Score at Week 24, in Previously Treated 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 primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Baseline, Week 24
Mean Change From Baseline in BCVA Letter Score at Week 24, in All 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 primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Baseline, Week 24
Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Treatment-Naive Participants
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Baseline, Week 24
Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Previously Treated Participants
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Baseline up to Week 24
Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in All Participants
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Baseline up to Week 24
Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Treatment-Naive Participants
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 24
Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Previously Treated Participants
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 24
Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in All Participants
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 24
Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Treatment-Naive Participants
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 24
Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Previously Treated Participants
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 24
Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in All Participants
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Time frame: Week 24
Mean Change From Baseline in Foveal Center Point Thickness at Week 24, 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).
Time frame: Baseline, Week 24
Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in Previously Treated 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).
Time frame: Baseline, Week 24
Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in All 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).
Time frame: Baseline, Week 24
Mean Change From Baseline in Central Subfield Thickness at Week 24, 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 SD-OCT.
Time frame: Baseline, Week 24
Mean Change From Baseline in Central Subfield Thickness at Week 24, in Previously Treated 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 SD-OCT.
Time frame: Baseline, Week 24
Mean Change From Baseline in Central Subfield Thickness at Week 24, in All 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 SD-OCT.
Time frame: Baseline, Week 24
Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants
Subretinal fluid is defined as the presence of fluid between the retina and the retinal pigment epithelium. Resolution of subretinal fluid was measured using SD-OCT.
Time frame: Week 24
Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants
Subretinal fluid is defined as the presence of fluid between the retina and the retinal pigment epithelium. Resolution of subretinal fluid was measured using SD-OCT.
Time frame: Week 24
Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants
Intraretinal fluid is described as the presence of fluid within the retina. Resolution of intraretinal fluid was measured by SD-OCT.
Time frame: Week 24
Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants
Intraretinal fluid is described as the presence of fluid within the retina. Resolution of intraretinal fluid was measured by SD-OCT.
Time frame: Week 24
Number of Participants With Presence or Absence of Leakage at the Macula at Week 24, in Treatment-Naive Participants
Leakage at the macula describes the leakage of fluorescein at the macula region as measured by fundus fluorescein angiography (FFA).
Time frame: Week 24
Number of Participants With Presence or Absence of Leakage at the Macula at Week 24, in Previously Treated Participants
Leakage at the macula describes the leakage of fluorescein at the macula region as measured by fundus fluorescein angiography (FFA).
Time frame: Week 24
Mean Change From Baseline in the Size of the Foveal Avascular Zone at Week 24, in All Participants
The size of the foveal avascular zone was to be measured by fundus fluorescein angiography (FFA).
Time frame: Baseline, Week 24
Mean Plasma Concentrations of Ranibizumab (Arm A) or Faricimab (Arms B and C) Over Time, in All Participants
Plasma concentrations of ranibizumab were measured by an appropriate assay only from samples of participants randomized to Arm A: 0.3 mg Ranibizumab. Plasma concentrations of faricimab were measured by a specific validated enzyme-linked immunoabsorbent assay (ELISA) only from samples of participants randomized to Arm B: 1.5 mg Faricimab and Arm C: 6 mg Faricimab. Baseline was defined as the last non-missing predose assessment. The lower limit of quantification (LLOQ) for the ranibizumab and faricimab assays were 0.015 nanograms per millilitre (ng/mL) and 0.800 ng/mL, respectively. Values below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Predose at Baseline and Weeks 1, 4, 12, 20, 24, 26, 28, 32, and 36
Baseline and Change From Baseline in Free Vascular Endothelial Growth Factor (VEGF) Plasma Levels Over Time, in Treatment-Naive Participants
The concentration of free VEGF was determined in plasma samples using an enzyme-linked immunosorbent assay (ELISA) method. The lower limit of quantification (LLOQ) of the assay was 15.6 picograms per millilitre (pg/mL). Plasma free VEGF concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36
Baseline and Change From Baseline in Free Vascular Endothelial Growth Factor (VEGF) Plasma Levels Over Time, in Previously Treated Participants
The concentration of free VEGF was determined in plasma samples using an enzyme-linked immunosorbent assay (ELISA) method. The lower limit of quantification (LLOQ) of the assay was 15.6 picograms per millilitre (pg/mL). Plasma free VEGF concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36
Baseline and Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Treatment-Naive Participants
Total Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.09 nanograms per millilitre (ng/mL). Plasma total Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36
Baseline and Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Treatment-Naive Participants
Free Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.9 nanograms per millilitre (ng/mL). Plasma free Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36
Baseline and Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Previously Treated Participants
Total Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.09 nanograms per millilitre (ng/mL). Plasma total Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36
Baseline and Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Levels Over Time, in Previously Treated Participants
Free Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.9 nanograms per millilitre (ng/mL). Plasma free Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Time frame: Baseline and Weeks 1, 4, 12, 16, 24, 26, 28, 32, and 36
Safety Summary of the Number of Participants With at Least One Adverse Event During the Treatment Period (up to Week 24), in All Participants
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) within 28 days of the end of the treatment period (i.e., up to Week 24). 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 of treatment with study drug, and AEs with fatal outcome. Multiple occurrences of the same AE in one individual were counted only once.
Time frame: From Baseline up to Week 24
Safety Summary of the Number of Participants With at Least One Adverse Event During the Post-Treatment Observation Period, in All Participants
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the post-treatment observation period (i.e., from Week 24 up to Week 36). 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 of treatment with study drug, and AEs with fatal outcome. Multiple occurrences of the same AE in one individual were counted only once.
Time frame: From Week 24 up to Week 36
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye During the Treatment Period by Highest Intensity, in All Participants
The investigator assessed adverse event severity according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.
Time frame: From Baseline up to Week 24
Number of Participants With at Least One Systemic Adverse Event During the Treatment Period by Highest Intensity, in All Participants
The investigator assessed adverse event severity according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.
Time frame: From Baseline up to Week 24
Number of Participants With Abnormal Systolic Blood Pressure Over Time, in All Participants
Abnormal systolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<70 (low) to \>180 (high) millimetres of mercury (mmHg) or a change from baseline of greater than 30 mmHg (decrease or increase). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36
Number of Participants With Abnormal Diastolic Blood Pressure Over Time, in All Participants
Abnormal diastolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<40 (low) to \>110 (high) millimetres of mercury (mmHg) or a change from baseline of greater than 20 mmHg (decrease or increase). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36
Number of Participants With an Abnormal Heart Rate Over Time, in All Participants
Abnormal heart rate (supine) was defined as any value outside of the standard reference range, from \<40 (low) to \>100 (high) beats per minute. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36
Number of Participants With Abnormal Body Temperature Over Time, in All Participants
Abnormal body temperature (supine) was defined as any value outside of the standard reference range, from \<36.5 (low) to \>37.5 (high) degrees Celsius. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 26, 28, 32, and 36
Mean Heart Rate at Baseline and Week 24, as Measured by Electrocardiogram in All Participants
Triplicate 12-lead electrocardiogram (ECG), i.e., three useful ECGs without artifacts, were performed on all evaluable participants. To minimize variability, it was important that participants be in a resting position for at least 10 minutes prior to the ECG evaluation. Body position was to be consistently maintained for each ECG evaluation to prevent changes in heart rate. Environmental distractions (e.g., television, radio, conversation, mobile phones) were to be minimized before and during ECG recording. Triplicate ECGs were to be obtained within a 5-minute interval. The predefined standard reference range for heart rate measured by ECG was 40 (low) to 100 (high) beats per minute.
Time frame: Baseline, Week 24
Mean PR, RR, QT, QRS, QTcB, and QTcF Intervals at Baseline and Week 24, as Measured by Electrocardiogram in All Participants
Triplicate 12-lead electrocardiogram (ECG), i.e., three useful ECGs without artifacts, were performed on all evaluable participants. To minimize variability, it was important that participants be in a resting position for at least 10 minutes prior to the ECG evaluation. Body position was to be consistently maintained for each ECG evaluation to prevent changes in heart rate. Environmental distractions (e.g., television, radio, conversation, mobile phones) were to be minimized before and during ECG recording. Triplicate ECGs were to be obtained within a 5-minute interval. Baseline was defined as the last non-missing predose assessment. The predefined standard reference ranges for the intervals measured by ECG were defined as follows (ranges are from low to high, in milliseconds \[msec\]): PR: 120-200 msec; RR: 600-1500 msec; QT: 200-500 msec; QRS: 40-120 msec.
Time frame: Baseline, Week 24
Number of Participants With Marked Laboratory Abnormalities in Hematology Tests, in All Participants
Clinical laboratory tests for hematology 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; Ery. = erythrocyte; Hemo. = hemoglobin
Time frame: Predose at Baseline, Weeks 12 and 24, 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. SGOT/AST = serum glutamic oxaloacetic transaminase / aspartate aminotransferase
Time frame: Predose at Baseline, Weeks 12 and 24, and at Early Termination and Unscheduled Visits (up to 36 weeks)
Number of Participants With Marked Laboratory Abnormalities in Coagulation Tests, in All Participants
Clinical laboratory tests for 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. aPTT = activated partial thromboplastin time; INR = International Normalized Ratio (prothrombin time)
Time frame: Predose at Baseline, Weeks 12 and 24, and at Early Termination and Unscheduled Visits (up to 36 weeks)
Number of Participants Who Tested Negative or Positive for Anti-Drug Antibodies Against Faricimab Over Time
The number and percentage of participants who tested negative or positive for plasma anti-drug antibodies (ADA) to faricimab at baseline and at the study visits was tabulated, except for those who were randomized to treatment with ranibizumab in Arm A.
Time frame: Baseline and Weeks 1, 4, 12, 16, 20, 24, 26, 28, 32, and 36
| Milestone | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Started | 90 | 55 | 82 |
| Received at least one dose of study drug | 89 | 55 | 80 |
| Completed up to week 24 | 81 | 53 | 73 |
| Completed | 75 | 50 | 67 |
| Not completed | 15 | 5 | 15 |
| Withdrew: Death | 2 | 1 | 2 |
| Withdrew: Met criteria for study exit | 0 | 0 | 1 |
| Withdrew: Protocol violation | 4 | 3 | 5 |
| Withdrew: Lost to follow-up | 3 | 0 | 5 |
| Withdrew: Physician decision | 2 | 0 | 0 |
| Withdrew: Withdrawal by subject | 3 | 1 | 2 |
| Withdrew: Adverse event | 1 | 0 | 0 |
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 primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.
| BCVA letters | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Change From Baseline in BCVA Letter Score at Week 24, in Treatment-Naive Participants | 10.3 (8.8 to 11.9) | 11.7 (10.1 to 13.3) | 13.9 (12.2 to 15.6) |
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 primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.
| BCVA letters | Arm A: 0.3 mg Ranibizumab | Arm C: 6 mg Faricimab |
|---|---|---|
| Mean Change From Baseline in BCVA Letter Score at Week 24, in Previously Treated Participants | 8.9 (5.7 to 10.8) | 9.6 (7.0 to 12.3) |
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 primary analysis used a Linear Mixed Effects Model for Repeated Measurements. Missing values were not imputed; it was assumed that the data were missing at random.
| BCVA letters | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Change From Baseline in BCVA Letter Score at Week 24, in All Participants | 9.4 (8.1 to 10.7) | 11.7 (10.0 to 13.4) | 12.3 (10.9 to 13.7) |
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Treatment-Naive Participants | 35.3 (27.3 to 44.1) | 36.0 (27.9 to 45.0) | 42.5 (33.5 to 52.1) |
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm C: 6 mg Faricimab |
|---|---|---|
| Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in Previously Treated Participants | 16.8 (9.6 to 27.8) | 23.2 (14.1 to 35.7) |
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Percentage of Participants Who Gained ≥15 ETDRS Letters From Baseline BCVA Score at Week 24, in All Participants | 28.7 (22.7 to 35.5) | 35.3 (27.4 to 44.2) | 35.9 (28.9 to 43.6) |
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Treatment-Naive Participants | 69.0 (60.2 to 76.7) | 78.5 (70.3 to 84.9) | 75.8 (66.8 to 83.0) |
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm C: 6 mg Faricimab |
|---|---|---|
| Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in Previously Treated Participants | 69.0 (57.3 to 78.7) | 68.4 (55.4 to 79.0) |
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Percentage of Participants With BCVA ≥69 Letters (20/40 or Better) at Week 24, in All Participants | 69.0 (62.1 to 75.2) | 78.9 (70.8 to 85.2) | 73.2 (65.9 to 79.4) |
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Treatment-Naive Participants | 11.5 (6.9 to 18.7) | 8.7 (4.8 to 15.3) | 9.8 (5.5 to 16.8) |
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm C: 6 mg Faricimab |
|---|---|---|
| Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in Previously Treated Participants | 10.5 (5.0 to 20.6) | 8.2 (3.3 to 19.1) |
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Percentage of Participants With BCVA ≥84 Letters (20/20 or Better) at Week 24, in All Participants | 11.1 (7.3 to 16.6) | 10.6 (6.2 to 17.5) | 9.1 (5.6 to 14.6) |
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).
| micrometers | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in Treatment-Naive Participants | -243.4 (-261.2 to -225.2) | -249.9 (-269.5 to -230.4) | -266.2 (-286.6 to -245.8) |
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).
| micrometers | Arm A: 0.3 mg Ranibizumab | Arm C: 6 mg Faricimab |
|---|---|---|
| Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in Previously Treated Participants | -162.1 (-186.9 to -137.3) | -211.3 (-237.1 to -185.5) |
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).
| micrometers | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Change From Baseline in Foveal Center Point Thickness at Week 24, in All Participants | -210.7 (-225.0 to -196.4) | -228.0 (-246.4 to -209.7) | -239.9 (-255.2 to -224.6) |
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 SD-OCT.
| micrometers | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Change From Baseline in Central Subfield Thickness at Week 24, in Treatment-Naive Participants | -204.7 (-219.6 to -189.8) | -217.1 (-233.0 to -201.2) | -225.8 (-242.5 to -209.1) |
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 SD-OCT.
| micrometers | Arm A: 0.3 mg Ranibizumab | Arm C: 6 mg Faricimab |
|---|---|---|
| Mean Change From Baseline in Central Subfield Thickness at Week 24, in Previously Treated Participants | -148.0 (-167.7 to -128.4) | -186.6 (-206.9 to -166.4) |
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 SD-OCT.
| micrometers | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Mean Change From Baseline in Central Subfield Thickness at Week 24, in All Participants | -180.2 (-191.6 to -168.8) | -200.3 (-214.8 to -185.8) | -206.9 (-219.0 to -194.8) |
Subretinal fluid is defined as the presence of fluid between the retina and the retinal pigment epithelium. Resolution of subretinal fluid was measured using SD-OCT.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants | 4.08 (0.46 to 7.70) | 0.00 (0.00 to 0.00) | 0.00 (0.00 to 0.00) |
Subretinal fluid is defined as the presence of fluid between the retina and the retinal pigment epithelium. Resolution of subretinal fluid was measured using SD-OCT.
| Percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm C: 6 mg Faricimab |
|---|---|---|
| Percentage of Participants With Presence of Subretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants | 7.14 (0.91 to 13.38) | 4.35 (0.00 to 9.80) |
Intraretinal fluid is described as the presence of fluid within the retina. Resolution of intraretinal fluid was measured by SD-OCT.
| percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Treatment-Naive Participants | 87.76 (81.75 to 93.76) | 81.63 (74.54 to 88.72) | 90.91 (85.35 to 96.46) |
Intraretinal fluid is described as the presence of fluid within the retina. Resolution of intraretinal fluid was measured by SD-OCT.
| percentage of participants | Arm A: 0.3 mg Ranibizumab | Arm C: 6 mg Faricimab |
|---|---|---|
| Percentage of Participants With Presence of Intraretinal Fluid in the Study Eye at Week 24, in Previously Treated Participants | 89.29 (81.79 to 96.78) | 91.30 (83.77 to 98.83) |
Leakage at the macula describes the leakage of fluorescein at the macula region as measured by fundus fluorescein angiography (FFA).
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Leakage Present | 41 | 41 | 25 |
| Leakage Absent | 4 | 5 | 11 |
Leakage at the macula describes the leakage of fluorescein at the macula region as measured by fundus fluorescein angiography (FFA).
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Leakage Present | 24 | 1 | 14 |
| Leakage Absent | 1 | 0 | 2 |
The size of the foveal avascular zone was to be measured by fundus fluorescein angiography (FFA).
No measurements were reported for this outcome.
Plasma concentrations of ranibizumab were measured by an appropriate assay only from samples of participants randomized to Arm A: 0.3 mg Ranibizumab. Plasma concentrations of faricimab were measured by a specific validated enzyme-linked immunoabsorbent assay (ELISA) only from samples of participants randomized to Arm B: 1.5 mg Faricimab and Arm C: 6 mg Faricimab. Baseline was defined as the last non-missing predose assessment. The lower limit of quantification (LLOQ) for the ranibizumab and faricimab assays were 0.015 nanograms per millilitre (ng/mL) and 0.800 ng/mL, respectively. Values below the limit of quantification were imputed as LLOQ divided by 2.
| nanograms per millilitre (ng/mL) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Baseline | 2.20 ± 7.84 | 0.40 ± 0.00 | 0.40 ± 0.00 |
| Week 1 | 2.52 ± 7.57 | 48.36 ± 22.46 | 172.24 ± 80.59 |
| Week 4 | 0.86 ± 2.27 | 6.97 ± 4.96 | 20.60 ± 13.46 |
| Week 12 | 0.26 ± 0.48 | 9.32 ± 5.93 | 22.38 ± 13.63 |
| Week 20 | 0.21 ± 0.35 | 7.11 ± 4.64 | 22.59 ± 18.10 |
| Week 24 | 0.20 ± 0.44 | 8.69 ± 5.06 | 20.18 ± 16.37 |
| Week 26 | 0.19 ± 0.47 | 3.80 ± 3.28 | 8.18 ± 6.98 |
| Week 28 | 0.10 ± 0.16 | 1.44 ± 2.42 | 2.94 ± 3.07 |
| Week 32 | 0.05 ± 0.09 | 0.46 ± 0.23 | 0.82 ± 0.97 |
| Week 36 | 0.03 ± 0.05 | 0.40 ± 0.00 | 0.40 ± 0.00 |
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.
| picograms per millilitre (pg/mL) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 23.93 ± 52.75 | 14.93 ± 19.70 | 12.45 ± 7.62 |
| Change from BL at Week 1 | -9.44 ± 49.77 | -3.85 ± 20.99 | -3.61 ± 6.96 |
| Change from BL at Week 4 | -1.68 ± 21.20 | -0.37 ± 21.76 | -0.49 ± 9.31 |
| Change from BL at Week 12 | -3.54 ± 22.50 | -1.61 ± 20.82 | 1.67 ± 16.69 |
| Change from BL at Week 16 | — | 0.00 ± NA | — |
| Change from BL at Week 24 | -7.31 ± 23.97 | 2.92 ± 18.23 | 2.83 ± 13.74 |
| Change from BL at Week 26 | -4.37 ± 13.09 | -2.98 ± 6.27 | -2.43 ± 7.08 |
| Change from BL at Week 28 | 0.30 ± 5.87 | 0.73 ± 12.17 | 7.15 ± 7.73 |
| Change from BL at Week 32 | -3.30 ± 8.13 | -35.85 ± 65.08 | 4.50 ± 5.97 |
| Change from BL at Week 36 | -1.75 ± 14.00 | 0.69 ± 7.71 | 2.07 ± 10.38 |
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.
| picograms per millilitre (pg/mL) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 12.94 ± 10.00 | 7.80 ± NA | 16.21 ± 10.22 |
| Change from BL at Week 1 | 0.50 ± 14.24 | 8.20 ± NA | -7.40 ± 12.08 |
| Change from BL at Week 4 | 0.93 ± 15.07 | 14.50 ± NA | -0.80 ± 11.11 |
| Change from BL at Week 12 | 13.83 ± 51.87 | 39.20 ± NA | 0.78 ± 16.55 |
| Change from BL at Week 16 | — | — | 19.10 ± NA |
| Change from BL at Week 24 | 6.60 ± 31.50 | 12.40 ± NA | 4.13 ± 27.51 |
| Change from BL at Week 26 | -0.25 ± 13.97 | — | 16.65 ± 42.34 |
| Change from BL at Week 28 | 7.32 ± 20.30 | — | 0.00 ± 0.00 |
| Change from BL at Week 32 | -1.13 ± 11.24 | — | 57.00 ± NA |
| Change from BL at Week 36 | 3.05 ± 11.44 | 21.50 ± NA | 3.53 ± 21.58 |
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.
| nanograms per millilitre (ng/mL) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 2.77 ± 2.01 | 2.07 ± 0.91 | 2.30 ± 1.88 |
| Change from BL at Week 1 | 0.07 ± 0.60 | 0.04 ± 0.80 | 0.75 ± 0.79 |
| Change from BL at Week 4 | 0.14 ± 0.72 | 0.05 ± 0.63 | 0.24 ± 0.79 |
| Change from BL at Week 12 | 0.06 ± 0.66 | 0.14 ± 0.51 | 0.18 ± 1.02 |
| Change from BL at Week 16 | — | -0.08 ± NA | — |
| Change from BL at Week 24 | 0.30 ± 0.80 | 0.40 ± 0.90 | 0.00 ± 0.61 |
| Change from BL at Week 26 | 0.25 ± 1.37 | 0.21 ± 0.33 | 0.58 ± 0.78 |
| Change from BL at Week 28 | 0.11 ± 0.35 | 0.34 ± 0.35 | -0.20 ± 0.49 |
| Change from BL at Week 32 | -0.35 ± 0.50 | 1.58 ± 1.91 | 0.42 ± 0.21 |
| Change from BL at Week 36 | 0.05 ± 0.83 | 0.39 ± 1.45 | -0.02 ± 0.83 |
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.
| nanograms per millilitre (ng/mL) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 3.05 ± 1.72 | 2.38 ± 1.04 | 2.46 ± 1.37 |
| Change from BL at Week 1 | -0.49 ± 0.46 | -0.59 ± 0.79 | 0.06 ± 1.01 |
| Change from BL at Week 4 | -0.36 ± 0.66 | -0.45 ± 0.72 | -0.22 ± 0.88 |
| Change from BL at Week 12 | -0.07 ± 0.87 | 0.10 ± 0.68 | 0.25 ± 1.11 |
| Change from BL at Week 16 | — | -0.74 ± NA | — |
| Change from BL at Week 24 | -0.08 ± 0.95 | 0.19 ± 1.14 | -0.11 ± 0.86 |
| Change from BL at Week 26 | -0.23 ± 1.27 | -0.26 ± 0.39 | 0.08 ± 0.76 |
| Change from BL at Week 28 | -0.56 ± 0.69 | -0.37 ± 0.44 | -0.54 ± 0.60 |
| Change from BL at Week 32 | -0.61 ± 0.58 | 0.92 ± 1.83 | -0.12 ± 0.28 |
| Change from BL at Week 36 | -0.61 ± 0.87 | -0.15 ± 1.03 | -0.26 ± 0.89 |
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.
| nanograms per millilitre (ng/mL) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 2.40 ± 2.34 | 1.84 ± NA | 2.31 ± 1.78 |
| Change from BL at Week 1 | 0.15 ± 14.24 | 0.11 ± NA | 0.94 ± 1.12 |
| Change from BL at Week 4 | 0.03 ± 0.52 | -0.27 ± NA | 0.14 ± 0.87 |
| Change from BL at Week 12 | 0.33 ± 1.66 | -0.28 ± NA | -0.09 ± 0.46 |
| Change from BL at Week 16 | — | — | -0.21 ± NA |
| Change from BL at Week 24 | 0.19 ± 1.22 | -0.19 ± NA | -0.16 ± 0.46 |
| Change from BL at Week 26 | -0.07 ± 0.64 | — | -0.20 ± 0.42 |
| Change from BL at Week 28 | 0.74 ± 2.78 | — | -0.91 ± 0.35 |
| Change from BL at Week 32 | -0.04 ± 0.79 | — | 0.49 ± NA |
| Change from BL at Week 36 | 0.01 ± 0.72 | -0.47 ± NA | -0.13 ± 0.42 |
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.
| nanograms per millilitre (ng/mL) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Baseline (BL) - Value at Visit | 2.67 ± 2.60 | 2.08 ± NA | 2.35 ± 1.76 |
| Change from BL at Week 1 | -0.07 ± 0.88 | -0.04 ± NA | 0.30 ± 0.87 |
| Change from BL at Week 4 | -0.33 ± 0.58 | -0.28 ± NA | -0.17 ± 0.66 |
| Change from BL at Week 12 | -0.05 ± 1.12 | -0.65 ± NA | -0.13 ± 0.61 |
| Change from BL at Week 16 | — | — | -0.49 ± NA |
| Change from BL at Week 24 | -0.28 ± 0.58 | -0.49 ± NA | -0.29 ± 0.64 |
| Change from BL at Week 26 | -0.21 ± 0.79 | — | -0.16 ± 0.54 |
| Change from BL at Week 28 | -0.17 ± 1.59 | — | -1.36 ± 0.83 |
| Change from BL at Week 32 | -0.59 ± 0.68 | — | 0.07 ± NA |
| Change from BL at Week 36 | -0.29 ± 0.72 | -0.72 ± NA | -0.19 ± 0.45 |
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) within 28 days of the end of the treatment period (i.e., up to Week 24). 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 of treatment with study drug, and AEs with fatal outcome. Multiple occurrences of the same AE in one individual were counted only once.
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Any AE | 61 | 38 | 54 |
| Ocular AE | 30 | 21 | 32 |
| Ocular AE in the Study Eye | 22 | 16 | 22 |
| Related Ocular AE in the Study Eye | 1 | 0 | 2 |
| Ocular AE in Study Eye Leading to Discontinuation | 1 | 0 | 0 |
| Serious Ocular AE in the Study Eye | 1 | 0 | 1 |
| Ocular AE in the Fellow Eye | 19 | 14 | 18 |
| Systemic AE | 51 | 30 | 46 |
| Related Systemic AE | 0 | 0 | 2 |
| Serious Systemic AE | 8 | 6 | 7 |
| Systemic AE Leading to Discontinuation | 0 | 1 | 0 |
| Any Related AE | 1 | 0 | 4 |
| Any Serious AE | 9 | 7 | 8 |
| Any Related Serious AE | 0 | 0 | 0 |
| AE with Fatal Outcome | 2 | 1 | 2 |
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the post-treatment observation period (i.e., from Week 24 up to Week 36). 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 of treatment with study drug, and AEs with fatal outcome. Multiple occurrences of the same AE in one individual were counted only once.
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Any AE | 31 | 21 | 34 |
| Ocular AE | 11 | 7 | 12 |
| Ocular AE in the Study Eye | 9 | 4 | 8 |
| Related Ocular AE in the Study Eye | 1 | 0 | 0 |
| Ocular AE in Study Eye Leading to Discontinuation | 0 | 0 | 0 |
| Serious Ocular AE in the Study Eye | 0 | 0 | 1 |
| Ocular AE in the Fellow Eye | 6 | 5 | 8 |
| Systemic AE | 22 | 15 | 25 |
| Related Systemic AE | 0 | 0 | 0 |
| Serious Systemic AE | 2 | 3 | 4 |
| Systemic AE Leading to Discontinuation | 0 | 0 | 0 |
| Any Related AE | 1 | 0 | 0 |
| Any Serious AE | 2 | 3 | 5 |
| Any Related Serious AE | 0 | 0 | 0 |
| AE with Fatal Outcome | 0 | 0 | 0 |
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.
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Study Eye - Ocular AE of Any Intensity | 22 | 16 | 22 |
| Study Eye - Mild Ocluar AE | 20 | 15 | 21 |
| Study Eye - Moderate Ocular AE | 2 | 3 | 3 |
| Study Eye - Severe Ocular AE | 1 | 0 | 0 |
| Fellow Eye - Ocular AE of Any Intensity | 19 | 14 | 18 |
| Fellow Eye - Mild Ocular AE | 13 | 13 | 14 |
| Fellow Eye - Moderate Ocular AE | 7 | 1 | 5 |
| Fellow Eye - Severe Ocular AE | 0 | 1 | 0 |
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.
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Systemic AE of Any Intensity | 51 | 30 | 46 |
| Mild Systemic AE | 34 | 19 | 34 |
| Moderate Systemic AE | 26 | 18 | 22 |
| Severe Systemic AE | 9 | 4 | 5 |
Abnormal systolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<70 (low) to \>180 (high) millimetres of mercury (mmHg) or a change from baseline of greater than 30 mmHg (decrease or increase). 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.
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Week 1 - Low | 0 | 0 | 0 |
| Week 1 - High | 1 | 3 | 0 |
| Week 4 - Low | 0 | 0 | 0 |
| Week 4 - High | 0 | 0 | 1 |
| Week 8 - Low | 0 | 0 | 0 |
| Week 8 - High | 1 | 0 | 2 |
| Week 12 - Low | 0 | 0 | 0 |
| Week 12 - High | 1 | 0 | 2 |
| Week 16 - Low | 0 | 0 | 0 |
| Week 16 - High | 0 | 1 | 1 |
| Week 20 - Low | 0 | 0 | 0 |
| Week 20 - High | 3 | 2 | 3 |
| Week 24 - Low | 0 | 0 | 0 |
| Week 24 - High | 2 | 2 | 2 |
| Week 26 - Low | 0 | 0 | 0 |
| Week 26 - High | 0 | 0 | 0 |
| Week 28 - Low | 0 | 0 | 0 |
| Week 28 - High | 1 | 1 | 1 |
| Week 32 - Low | 0 | 0 | 0 |
| Week 32 - High | 4 | 1 | 2 |
| Week 36 - Low | 0 | 0 | 0 |
| Week 36 - High | 1 | 0 | 2 |
Abnormal diastolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<40 (low) to \>110 (high) millimetres of mercury (mmHg) or a change from baseline of greater than 20 mmHg (decrease or increase). 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.
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Week 1 - Low | 0 | 0 | 0 |
| Week 1 - High | 1 | 0 | 0 |
| Week 4 - Low | 0 | 0 | 0 |
| Week 4 - High | 0 | 0 | 0 |
| Week 8 - Low | 0 | 0 | 0 |
| Week 8 - High | 0 | 0 | 0 |
| Week 12 - Low | 0 | 0 | 0 |
| Week 12 - High | 0 | 0 | 2 |
| Week 16 - Low | 0 | 0 | 0 |
| Week 16 - High | 0 | 0 | 0 |
| Week 20 - Low | 0 | 0 | 0 |
| Week 20 - High | 1 | 0 | 1 |
| Week 24 - Low | 0 | 0 | 0 |
| Week 24 - High | 1 | 0 | 0 |
| Week 26 - Low | 0 | 0 | 0 |
| Week 26 - High | 1 | 0 | 0 |
| Week 28 - Low | 0 | 0 | 0 |
| Week 28 - High | 0 | 0 | 0 |
| Week 32 - Low | 0 | 0 | 0 |
| Week 32 - High | 1 | 1 | 0 |
| Week 36 - Low | 0 | 0 | 0 |
| Week 36 - High | 0 | 0 | 1 |
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.
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Week 1 - Low | 0 | 0 | 0 |
| Week 1 - High | 0 | 0 | 1 |
| Week 4 - Low | 0 | 0 | 0 |
| Week 4 - High | 1 | 0 | 0 |
| Week 8 - Low | 0 | 0 | 0 |
| Week 8 - High | 0 | 0 | 0 |
| Week 12 - Low | 0 | 0 | 0 |
| Week 12 - High | 1 | 0 | 1 |
| Week 16 - Low | 0 | 0 | 0 |
| Week 16 - High | 2 | 0 | 3 |
| Week 20 - Low | 0 | 0 | 0 |
| Week 20 - High | 1 | 0 | 1 |
| Week 24 - Low | 0 | 0 | 0 |
| Week 24 - High | 1 | 0 | 2 |
| Week 26 - Low | 0 | 0 | 0 |
| Week 26 - High | 2 | 0 | 1 |
| Week 28 - Low | 0 | 0 | 0 |
| Week 28 - High | 0 | 0 | 2 |
| Week 32 - Low | 0 | 0 | 0 |
| Week 32 - High | 1 | 0 | 0 |
| Week 36 - Low | 0 | 0 | 0 |
| Week 36 - High | 0 | 0 | 0 |
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.
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Week 1 - Low | 8 | 4 | 7 |
| Week 1 - High | 0 | 0 | 1 |
| Week 4 - Low | 13 | 2 | 8 |
| Week 4 - High | 0 | 1 | 0 |
| Week 8 - Low | 14 | 4 | 9 |
| Week 8 - High | 1 | 1 | 1 |
| Week 12 - Low | 9 | 4 | 14 |
| Week 12 - High | 1 | 1 | 0 |
| Week 16 - Low | 5 | 3 | 13 |
| Week 16 - High | 1 | 1 | 0 |
| Week 20 - Low | 8 | 6 | 7 |
| Week 20 - High | 0 | 0 | 0 |
| Week 24 - Low | 13 | 6 | 10 |
| Week 24 - High | 0 | 0 | 1 |
| Week 26 - Low | 3 | 1 | 5 |
| Week 26 - High | 1 | 0 | 1 |
| Week 28 - Low | 11 | 4 | 10 |
| Week 28 - High | 0 | 0 | 1 |
| Week 32 - Low | 7 | 7 | 9 |
| Week 32 - High | 1 | 0 | 0 |
| Week 36 - Low | 5 | 7 | 8 |
| Week 36 - High | 0 | 0 | 0 |
Triplicate 12-lead electrocardiogram (ECG), i.e., three useful ECGs without artifacts, were performed on all evaluable participants. To minimize variability, it was important that participants be in a resting position for at least 10 minutes prior to the ECG evaluation. Body position was to be consistently maintained for each ECG evaluation to prevent changes in heart rate. Environmental distractions (e.g., television, radio, conversation, mobile phones) were to be minimized before and during ECG recording. Triplicate ECGs were to be obtained within a 5-minute interval. The predefined standard reference range for heart rate measured by ECG was 40 (low) to 100 (high) beats per minute.
| beats per minute | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Baseline | 71.52 ± 14.47 | 73.65 ± 10.43 | 74.12 ± 12.89 |
| Week 24 | 71.12 ± 12.53 | 73.96 ± 11.32 | 75.61 ± 11.46 |
Triplicate 12-lead electrocardiogram (ECG), i.e., three useful ECGs without artifacts, were performed on all evaluable participants. To minimize variability, it was important that participants be in a resting position for at least 10 minutes prior to the ECG evaluation. Body position was to be consistently maintained for each ECG evaluation to prevent changes in heart rate. Environmental distractions (e.g., television, radio, conversation, mobile phones) were to be minimized before and during ECG recording. Triplicate ECGs were to be obtained within a 5-minute interval. Baseline was defined as the last non-missing predose assessment. The predefined standard reference ranges for the intervals measured by ECG were defined as follows (ranges are from low to high, in milliseconds \[msec\]): PR: 120-200 msec; RR: 600-1500 msec; QT: 200-500 msec; QRS: 40-120 msec.
| milliseconds | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| PR Interval at Baseline | 172.57 ± 28.62 | 168.50 ± 31.82 | 170.91 ± 29.06 |
| PR Interval at Week 24 | 171.95 ± 30.21 | 167.49 ± 26.20 | 172.02 ± 28.81 |
| RR Interval at Baseline | 864.44 ± 160.30 | 826.04 ± 119.67 | 828.64 ± 146.42 |
| RR Interval at Week 24 | 864.34 ± 154.93 | 824.13 ± 126.72 | 806.45 ± 124.82 |
| QT Interval at Baseline | 395.40 ± 40.47 | 387.87 ± 30.52 | 386.97 ± 32.65 |
| QT Interval at Week 24 | 393.96 ± 36.74 | 384.30 ± 28.03 | 381.50 ± 28.10 |
| QRS Interval at Baseline | 98.84 ± 19.80 | 96.06 ± 16.76 | 95.26 ± 15.54 |
| QRS Interval at Week 24 | 98.82 ± 19.90 | 96.66 ± 11.24 | 95.40 ± 17.83 |
| QTcB Interval at Baseline | 426.98 ± 24.47 | 427.85 ± 24.33 | 426.91 ± 22.84 |
| QTcB Interval at Week 24 | 425.60 ± 25.55 | 424.79 ± 22.93 | 426.31 ± 23.36 |
| QTcF Interval at Baseline | 415.60 ± 25.63 | 413.61 ± 23.15 | 412.67 ± 21.17 |
| QTcF Interval at Week 24 | 414.21 ± 24.75 | 410.45 ± 20.35 | 410.42 ± 20.61 |
Clinical laboratory tests for hematology 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; Ery. = erythrocyte; Hemo. = hemoglobin
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Eosinophils, Abs., High - Any Abnormality | 2 | 1 | 3 |
| Eosinophils, Abs., High - Single, Not Last | 1 | 1 | 3 |
| Eosinophils, Abs., High - Last or Replicated | 1 | 0 | 0 |
| Hematocrit, Low - Any Abnormality | 4 | 1 | 1 |
| Hematocrit, Low - Single, Not Last | 1 | 0 | 1 |
| Hematocrit, Low - Last or Replicated | 3 | 1 | 0 |
| Hemoglobin, Low - Any Abnormality | 4 | 1 | 2 |
| Hemoglobin, Low - Single, Not Last | 1 | 0 | 2 |
| Hemoglobin, Low - Last or Replicated | 3 | 1 | 0 |
| Lymphocytes, Abs., Low - Any Abnormality | 1 | 0 | 1 |
| Lymphocytes, Abs., Low - Single, Not Last | 1 | 0 | 1 |
| Lymphocytes, Abs., Low - Last or Replicated | 0 | 0 | 0 |
| Ery. Mean Corpuscular Hemo., Low - Any Abnormality | 0 | 0 | 1 |
| Ery. Mean Corpuscular Hemo., Low -Single, Not Last | 0 | 0 | 0 |
| Ery. Mean Corpuscular Hemo.,Low-Last or Replicated | 0 | 0 | 1 |
| Neutrophils, Total, Abs., Low - Any Abnormality | 1 | 1 | 0 |
| Neutrophils, Total, Abs., Low - Single, Not Last | 1 | 0 | 0 |
| Neutrophils, Total, Abs., Low -Last or Replicated | 0 | 1 | 0 |
| Neutrophils, Total, Abs., High - Any Abnormality | 2 | 0 | 2 |
| Neutrophils, Total, Abs., High - Single, Not Last | 1 | 0 | 0 |
| Neutrophils, Total, Abs., High -Last or Replicated | 1 | 0 | 2 |
| Platelets, Low - Any Abnormality | 1 | 1 | 0 |
| Platelets, Low - Single, Not Last | 0 | 0 | 0 |
| Platelets, Low - Last or Replicated | 1 | 1 | 0 |
| Platelets, High - Any Abnormality | 1 | 0 | 0 |
| Platelets, High - Single, Not Last | 0 | 0 | 0 |
| Platelets, High - Last or Replicated | 1 | 0 | 0 |
| Red Blood Cell Count, Low - Any Abnormality | 3 | 1 | 1 |
| Red Blood Cell Count, Low - Single, Not Last | 2 | 0 | 1 |
| Red Blood Cell Count, Low - Last or Replicated | 1 | 1 | 0 |
| White Blood Cell Count, Low - Any Abnormality | 1 | 2 | 1 |
| White Blood Cell Count, Low - Single, Not Last | 1 | 1 | 1 |
| White Blood Cell Count, Low - Last or Replicated | 0 | 1 | 0 |
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. SGOT/AST = serum glutamic oxaloacetic transaminase / aspartate aminotransferase
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Alkaline Phosphatase, High - Any Abnormality | 0 | 0 | 1 |
| Alkaline Phosphatase, High - Single, Not Last | 0 | 0 | 0 |
| Alkaline Phosphatase, High - Last or Replicated | 0 | 0 | 1 |
| SGOT/AST, High - Any Abnormality | 0 | 1 | 0 |
| SGOT/AST, High - Single, Not Last | 0 | 0 | 0 |
| SGOT/AST, High - Last or Replicated | 0 | 1 | 0 |
| Bicarbonate, Low - Any Abnormality | 4 | 1 | 2 |
| Bicarbonate, Low - Single, Not Last | 0 | 0 | 1 |
| Bicarbonate, Low - Last or Replicated | 4 | 1 | 1 |
| Bicarbonate, High - Any Abnormality | 1 | 0 | 1 |
| Bicarbonate, High - Single, Not Last | 0 | 0 | 0 |
| Bicarbonate, High - Last or Replicated | 1 | 0 | 1 |
| Blood Urea Nitrogen, High - Any Abnormality | 2 | 3 | 3 |
| Blood Urea Nitrogen, High - Single, Not Last | 0 | 0 | 0 |
| Blood Urea Nitrogen, High - Last or Replicated | 2 | 3 | 3 |
| Calcium, Low - Any Abnormality | 2 | 0 | 2 |
| Calcium, Low - Single, Not Last | 1 | 0 | 1 |
| Calcium, Low - Last or Replicated | 1 | 0 | 1 |
| Chloride, Low - Any Abnormality | 3 | 1 | 0 |
| Chloride, Low - Single, Not Last | 2 | 1 | 0 |
| Chloride, Low - Last or Replicated | 1 | 0 | 0 |
| Cholesterol, High - Any Abnormality | 0 | 1 | 0 |
| Cholesterol, High - Single, Not Last | 0 | 0 | 0 |
| Cholesterol, High - Last or Replicated | 0 | 1 | 0 |
| Creatine Kinase, High - Any Abnormality | 3 | 0 | 1 |
| Creatine Kinase, High - Single, Not Last | 1 | 0 | 1 |
| Creatine Kinase, High - Last or Replicated | 2 | 0 | 0 |
| Creatinine, High - Any Abnormality | 1 | 0 | 2 |
| Creatinine, High - Single, Not Last | 0 | 0 | 0 |
| Creatinine, High - Last or Replicated | 1 | 0 | 2 |
| Gamma Glutamyl Transferase, High-Any Abnormality | 3 | 0 | 2 |
| Gamma Glutamyl Transferase, High-Single, Not Last | 1 | 0 | 0 |
| Gamma Glutamyl Transferase,High-Last or Replicated | 2 | 0 | 2 |
| Phosphorus, Low - Any Abnormality | 0 | 1 | 1 |
| Phosphorus, Low - Single, Not Last | 0 | 1 | 0 |
| Phosphorus, Low - Last or Replicated | 0 | 0 | 1 |
| Phosphorus, High - Any Abnormality | 3 | 0 | 1 |
| Phosphorus, High - Single, Not Last | 2 | 0 | 0 |
| Phosphorus, High - Last or Replicated | 1 | 0 | 1 |
| Potassium, High - Any Abnormality | 1 | 0 | 1 |
| Potassium, High - Single, Not Last | 0 | 0 | 1 |
| Potassium, High - Last or Replicated | 1 | 0 | 0 |
| Sodium, Low - Any Abnormality | 1 | 0 | 0 |
| Sodium, Low - Single, Not Last | 0 | 0 | 0 |
| Sodium, Low - Last or Replicated | 1 | 0 | 0 |
| Bilirubin, High - Any Abnormality | 0 | 0 | 1 |
| Bilirubin, High - Single, Not Last | 0 | 0 | 0 |
| Bilirubin, High - Last or Replicated | 0 | 0 | 1 |
| Protein, Total, Low - Any Abnormality | 0 | 0 | 1 |
| Protein, Total, Low - Single, Not Last | 0 | 0 | 0 |
| Protein, Total, Low - Last or Replicated | 0 | 0 | 1 |
Clinical laboratory tests for 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. aPTT = activated partial thromboplastin time; INR = International Normalized Ratio (prothrombin time)
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| INR, High - Any Abnormality | 1 | 0 | 0 |
| INR, High - Single, Not Last | 0 | 0 | 0 |
| INR, High - Last or Replicated | 1 | 0 | 0 |
| aPTT, High - Any Abnormality | 5 | 1 | 1 |
| aPTT, High - Single, Not Last | 2 | 0 | 0 |
| aPTT, High - Last or Replicated | 3 | 1 | 1 |
The number and percentage of participants who tested negative or positive for plasma anti-drug antibodies (ADA) to faricimab at baseline and at the study visits was tabulated, except for those who were randomized to treatment with ranibizumab in Arm A.
| Participants | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| Baseline - ADA Negative | — | 53 | 75 |
| Baseline - ADA Positive | — | 1 | 2 |
| Week 1 - ADA Negative | — | 50 | 67 |
| Week 1 - ADA Positive | — | 2 | 1 |
| Week 4 - ADA Negative | — | 52 | 74 |
| Week 4 - ADA Positive | — | 1 | 2 |
| Week 12 - ADA Negative | — | 49 | 68 |
| Week 12 - ADA Positive | — | 2 | 3 |
| Week 16 - ADA Negative | — | 1 | 1 |
| Week 16 - ADA Positive | — | 0 | 0 |
| Week 20 - ADA Negative | — | 50 | 65 |
| Week 20 - ADA Positive | — | 2 | 5 |
| Week 24 - ADA Negative | — | 46 | 58 |
| Week 24 - ADA Positive | — | 3 | 6 |
| Week 26 - ADA Negative | — | 2 | 5 |
| Week 26 - ADA Positive | — | 0 | 0 |
| Week 28 - ADA Negative | — | 6 | 7 |
| Week 28 - ADA Positive | — | 0 | 0 |
| Week 32 - ADA Negative | — | 5 | 5 |
| Week 32 - ADA Positive | — | 0 | 0 |
| Week 36 - ADA Negative | — | 32 | 47 |
| Week 36 - ADA Positive | — | 4 | 6 |
Collected over From Baseline until the final study visit (up to 36 weeks). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: 0.3 mg Ranibizumab | 2/89 (2.2%) | 9/89 (10.1%) | 48/89 (53.9%) |
| Arm B: 1.5 mg Faricimab | 1/55 (1.8%) | 7/55 (12.7%) | 31/55 (56.4%) |
| Arm C: 6 mg Faricimab | 2/80 (2.5%) | 8/80 (10%) | 45/80 (56.3%) |
| Event | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| PneumoniaInfections and infestations | 0/89 | 2/55 | 0/80 |
| Cardiac failure congestiveCardiac disorders | 2/89 | 1/55 | 0/80 |
| CellulitisInfections and infestations | 2/89 | 0/55 | 0/80 |
| Visual acuity reducedEye disorders | 0/89 | 1/55 | 0/80 |
| BronchitisInfections and infestations | 0/89 | 1/55 | 0/80 |
| GangreneInfections and infestations | 1/89 | 1/55 | 0/80 |
| Fracture displacementInjury, poisoning and procedural complications | 0/89 | 1/55 | 0/80 |
| Multiple injuriesInjury, poisoning and procedural complications | 0/89 | 1/55 | 0/80 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/89 | 1/55 | 0/80 |
| Neuropathic arthropathyMusculoskeletal and connective tissue disorders | 0/89 | 1/55 | 0/80 |
| Event | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab |
|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 9/89 | 1/55 | 5/80 |
| Conjunctival haemorrhageEye disorders | 7/89 | 2/55 | 8/80 |
| HypertensionVascular disorders | 7/89 | 5/55 | 6/80 |
| Upper respiratory tract infectionInfections and infestations | 1/89 | 0/55 | 6/80 |
| Diabetic retinal oedemaEye disorders | 4/89 | 4/55 | 5/80 |
| Retinal exudatesEye disorders | 1/89 | 4/55 | 3/80 |
| Urinary tract infectionInfections and infestations | 6/89 | 4/55 | 1/80 |
| NasopharyngitisInfections and infestations | 3/89 | 3/55 | 5/80 |
| Eye painEye disorders | 3/89 | 3/55 | 2/80 |
| Vision blurredEye disorders | 2/89 | 3/55 | 2/80 |
Two participants randomized to Arm C: 6 mg Faricimab were excluded from the analysis populations due to Good Clinical Practice (GCP) non-compliance at a single site.
| Age, Continuous(Years) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab | Total |
|---|---|---|---|---|
| All Participants | 62.3 ± 9.2 | 61.5 ± 7.7 | 60.8 ± 9.2 | 61.6 ± 8.8 |
| Treatment-Naive Participants | 61.6 ± 9.5 | 61.4 ± 7.7 | 60.5 ± 9.1 | 61.2 ± 8.8 |
| Previously Treated Participants | 63.5 ± 8.7 | 63.0 ± NA | 61.5 ± 9.5 | 62.6 ± 9.0 |
| Sex: Female, Male(Participants) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab | Total |
|---|---|---|---|---|
| All Participants — Female | 36 | 35 | 36 | 107 |
| All Participants — Male | 54 | 20 | 46 | 120 |
| Treatment-Naive Participants — Female | 22 | 35 | 20 | 77 |
| Treatment-Naive Participants — Male | 37 | 19 | 33 | 89 |
| Previously Treated Participants — Female | 14 | 0 | 16 | 30 |
| Previously Treated Participants — Male | 17 | 1 | 13 | 31 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab | Total |
|---|---|---|---|---|
| All Participants — Hispanic or Latino | 15 | 8 | 16 | 39 |
| All Participants — Not Hispanic or Latino | 74 | 47 | 66 | 187 |
| All Participants — Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Treatment-Naive Participants — Hispanic or Latino | 11 | 8 | 9 | 28 |
| Treatment-Naive Participants — Not Hispanic or Latino | 48 | 46 | 44 | 138 |
| Treatment-Naive Participants — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Previously Treated Participants — Hispanic or Latino | 4 | 0 | 7 | 11 |
| Previously Treated Participants — Not Hispanic or Latino | 26 | 1 | 22 | 49 |
| Previously Treated Participants — Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab | Total |
|---|---|---|---|---|
| All Participants — American Indian or Alaska Native | 1 | 0 | 2 | 3 |
| All Participants — Asian | 0 | 0 | 1 | 1 |
| All Participants — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| All Participants — Black or African American | 17 | 11 | 14 | 42 |
| All Participants — White | 71 | 43 | 61 | 175 |
| All Participants — More than one race | 0 | 0 | 0 | 0 |
| All Participants — Unknown or Not Reported | 1 | 1 | 4 | 6 |
| Treatment-Naive Participants — American Indian or Alaska Native | 0 | 0 | 2 | 2 |
| Treatment-Naive Participants — Asian | 0 | 0 | 1 | 1 |
| Treatment-Naive Participants — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Treatment-Naive Participants — Black or African American | 9 | 11 | 10 | 30 |
| Treatment-Naive Participants — White | 49 | 42 | 39 | 130 |
| Treatment-Naive Participants — More than one race | 0 | 0 | 0 | 0 |
| Treatment-Naive Participants — Unknown or Not Reported | 1 | 1 | 1 | 3 |
| Previously Treated Participants — American Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Previously Treated Participants — Asian | 0 | 0 | 0 | 0 |
| Previously Treated Participants — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Previously Treated Participants — Black or African American | 8 | 0 | 4 | 12 |
| Previously Treated Participants — White | 22 | 1 | 22 | 45 |
| Previously Treated Participants — More than one race | 0 | 0 | 0 | 0 |
| Previously Treated Participants — Unknown or Not Reported | 0 | 0 | 3 | 3 |
| Anti-VEGF Treatment Experience Status (Treatment-Naive or Previously Treated)(Participants) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab | Total |
|---|---|---|---|---|
| Treatment-Naive | 59 | 54 | 53 | 166 |
| Previously Treated | 31 | 1 | 29 | 61 |
| Best Corrected Visual Acuity (BCVA) ETDRS Letter Score in the Study Eye at Baseline(Score on a scale) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab | Total |
|---|---|---|---|---|
| All Participants | 61.51 ± 10.43 | 61.16 ± 11.12 | 59.48 ± 12.49 | 60.70 ± 11.36 |
| Treatment-Naive Participants | 61.24 ± 9.87 | 60.94 ± 11.11 | 60.00 ± 10.95 | 60.75 ± 10.58 |
| Previously Treated Participants | 62.00 ± 11.56 | 73.00 ± NA | 58.55 ± 14.98 | 60.54 ± 13.31 |
| Previous Macular Laser Treatment Status(Participants) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab | Total |
|---|---|---|---|---|
| All Participants — Previous Macular Laser Treatment | 16 | 4 | 15 | 35 |
| All Participants — No Previous Macular Laser Treatment | 74 | 51 | 67 | 192 |
| Treatment-Naive Participants — Previous Macular Laser Treatment | 6 | 4 | 3 | 13 |
| Treatment-Naive Participants — No Previous Macular Laser Treatment | 53 | 50 | 50 | 153 |
| Previously Treated Participants — Previous Macular Laser Treatment | 10 | 0 | 12 | 22 |
| Previously Treated Participants — No Previous Macular Laser Treatment | 21 | 1 | 17 | 39 |
| Mean Foveal Center Point Thickness at Baseline(micrometers) | Arm A: 0.3 mg Ranibizumab | Arm B: 1.5 mg Faricimab | Arm C: 6 mg Faricimab | Total |
|---|---|---|---|---|
| All Participants | 459.88 ± 162.09 | 494.64 ± 200.51 | 440.50 ± 150.42 | 461.49 ± 168.97 |
| Treatment-Naive Participants | 464.19 ± 166.00 | 497.78 ± 201.02 | 456.70 ± 156.12 | 472.97 ± 175.37 |
| Previously Treated Participants | 451.82 ± 156.87 | 325.00 ± NA | 412.02 ± 137.83 | 430.82 ± 147.49 |
3 further baseline measures are reported on the registry.
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Hoffmann-La Roche