Trial Outcomes & Findings for Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration (NCT NCT03038880)
NCT ID: NCT03038880
Last Updated: 2021-01-05
Results Overview
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline BCVA.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Baseline, Week 40
Results posted on
2021-01-05
Participant Flow
Participant milestones
| Measure |
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
31
|
16
|
|
Overall Study
COMPLETED
|
21
|
28
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
0
|
Reasons for withdrawal
| Measure |
6 mg Faricimab Q12W
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Faricimab (RO6867461; RG7716) for Extended Durability in the Treatment of Neovascular Age Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
80.3 Years
STANDARD_DEVIATION 7.23 • n=5 Participants
|
77.7 Years
STANDARD_DEVIATION 8.38 • n=7 Participants
|
77.3 Years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
78.5 Years
STANDARD_DEVIATION 8.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Baseline
|
57.8 ETDRS Letters
STANDARD_DEVIATION 10.46 • n=5 Participants
|
60.4 ETDRS Letters
STANDARD_DEVIATION 10.80 • n=7 Participants
|
55.3 ETDRS Letters
STANDARD_DEVIATION 12.08 • n=5 Participants
|
58.4 ETDRS Letters
STANDARD_DEVIATION 11.02 • n=4 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline
Classic and Occult CNV
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline
Classic CNV
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline
Occult CNV
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Central Foveal Thickness in the Study Eye at Baseline
|
290.8 microns (μm)
STANDARD_DEVIATION 118.61 • n=5 Participants
|
280.8 microns (μm)
STANDARD_DEVIATION 98.95 • n=7 Participants
|
375.6 microns (μm)
STANDARD_DEVIATION 159.41 • n=5 Participants
|
305.6 microns (μm)
STANDARD_DEVIATION 125.42 • n=4 Participants
|
|
Central Subfield Thickness in the Study Eye at Baseline
|
417.9 microns (μm)
STANDARD_DEVIATION 84.28 • n=5 Participants
|
382.2 microns (μm)
STANDARD_DEVIATION 80.87 • n=7 Participants
|
443.1 microns (μm)
STANDARD_DEVIATION 125.00 • n=5 Participants
|
408.0 microns (μm)
STANDARD_DEVIATION 95.36 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 40Population: Efficacy population: participants grouped according to their assigned treatment.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline BCVA.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 40, Using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA Charts
|
9.3 ETDRS Letters
Interval 6.4 to 12.3
|
12.5 ETDRS Letters
Interval 9.9 to 15.1
|
11.4 ETDRS Letters
Interval 7.8 to 15.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline BCVA.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Day 7
|
3.78 ETDRS Letters
Interval 2.33 to 5.24
|
4.62 ETDRS Letters
Interval 3.33 to 5.91
|
3.53 ETDRS Letters
Interval 1.74 to 5.33
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 4
|
5.99 ETDRS Letters
Interval 4.1 to 7.88
|
7.55 ETDRS Letters
Interval 5.88 to 9.22
|
7.53 ETDRS Letters
Interval 5.21 to 9.86
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 8
|
5.28 ETDRS Letters
Interval 2.88 to 7.69
|
9.15 ETDRS Letters
Interval 7.01 to 11.29
|
10.55 ETDRS Letters
Interval 7.55 to 13.54
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 12
|
7.31 ETDRS Letters
Interval 4.87 to 9.75
|
10.19 ETDRS Letters
Interval 8.04 to 12.34
|
9.91 ETDRS Letters
Interval 6.94 to 12.88
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 16
|
8.31 ETDRS Letters
Interval 5.93 to 10.68
|
11.62 ETDRS Letters
Interval 9.52 to 13.71
|
10.78 ETDRS Letters
Interval 7.89 to 13.68
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 20
|
8.02 ETDRS Letters
Interval 5.35 to 10.69
|
10.40 ETDRS Letters
Interval 8.05 to 12.76
|
11.53 ETDRS Letters
Interval 8.28 to 14.78
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 24
|
8.11 ETDRS Letters
Interval 5.53 to 10.69
|
10.37 ETDRS Letters
Interval 8.1 to 12.65
|
10.97 ETDRS Letters
Interval 7.83 to 14.11
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 28
|
9.59 ETDRS Letters
Interval 7.06 to 12.12
|
11.82 ETDRS Letters
Interval 9.59 to 14.05
|
12.16 ETDRS Letters
Interval 9.08 to 15.23
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 32
|
9.87 ETDRS Letters
Interval 7.21 to 12.53
|
12.44 ETDRS Letters
Interval 10.1 to 14.79
|
11.91 ETDRS Letters
Interval 8.67 to 15.14
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 36
|
9.01 ETDRS Letters
Interval 6.14 to 11.87
|
12.38 ETDRS Letters
Interval 9.86 to 14.9
|
12.03 ETDRS Letters
Interval 8.57 to 15.5
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 40
|
9.33 ETDRS Letters
Interval 6.37 to 12.29
|
12.47 ETDRS Letters
Interval 9.86 to 15.08
|
11.42 ETDRS Letters
Interval 7.83 to 15.01
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 44
|
9.38 ETDRS Letters
Interval 6.42 to 12.34
|
12.07 ETDRS Letters
Interval 9.48 to 14.67
|
11.22 ETDRS Letters
Interval 7.65 to 14.79
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 48
|
9.53 ETDRS Letters
Interval 6.51 to 12.55
|
10.99 ETDRS Letters
Interval 8.33 to 13.64
|
10.22 ETDRS Letters
Interval 6.57 to 13.86
|
|
Mean Change From Baseline in BCVA at Specified Timepoints, Using the ETDRS BCVA Charts
Week 52
|
10.08 ETDRS Letters
Interval 7.05 to 13.12
|
11.42 ETDRS Letters
Interval 8.75 to 14.09
|
9.59 ETDRS Letters
Interval 5.93 to 13.25
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 28: Gaining ≥0 Letters
|
21 Participants
|
27 Participants
|
16 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 8: Gaining ≥15 Letters
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 4: Gaining ≥15 Letters
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 4: Gaining ≥10 Letters
|
5 Participants
|
8 Participants
|
5 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 4: Gaining ≥5 Letters
|
15 Participants
|
19 Participants
|
8 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 4: Gaining ≥0 Letters
|
20 Participants
|
30 Participants
|
15 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 8: Gaining ≥10 Letters
|
7 Participants
|
10 Participants
|
8 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 8: Gaining ≥5 Letters
|
14 Participants
|
26 Participants
|
10 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 8: Gaining ≥0 Letters
|
21 Participants
|
28 Participants
|
15 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 12: Gaining ≥15 Letters
|
2 Participants
|
7 Participants
|
3 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 12: Gaining ≥10 Letters
|
8 Participants
|
16 Participants
|
7 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 12: Gaining ≥5 Letters
|
15 Participants
|
23 Participants
|
11 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 12: Gaining ≥0 Letters
|
19 Participants
|
29 Participants
|
15 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 16: Gaining ≥15 Letters
|
4 Participants
|
9 Participants
|
3 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 16: Gaining ≥10 Letters
|
10 Participants
|
16 Participants
|
8 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 16: Gaining ≥5 Letters
|
16 Participants
|
27 Participants
|
13 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 16: Gaining ≥0 Letters
|
21 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 20: Gaining ≥15 Letters
|
4 Participants
|
10 Participants
|
3 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 20: Gaining ≥10 Letters
|
10 Participants
|
17 Participants
|
9 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 20: Gaining ≥5 Letters
|
16 Participants
|
22 Participants
|
14 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 20: Gaining ≥0 Letters
|
20 Participants
|
26 Participants
|
16 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 24: Gaining ≥15 Letters
|
4 Participants
|
8 Participants
|
4 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 24: Gaining ≥10 Letters
|
9 Participants
|
16 Participants
|
9 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 24: Gaining ≥5 Letters
|
15 Participants
|
22 Participants
|
12 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 24: Gaining ≥0 Letters
|
19 Participants
|
27 Participants
|
15 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 28: Gaining ≥15 Letters
|
6 Participants
|
12 Participants
|
5 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 28: Gaining ≥10 Letters
|
13 Participants
|
15 Participants
|
9 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 28: Gaining ≥5 Letters
|
16 Participants
|
24 Participants
|
11 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 32: Gaining ≥15 Letters
|
7 Participants
|
11 Participants
|
6 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 32: Gaining ≥10 Letters
|
11 Participants
|
18 Participants
|
9 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 32: Gaining ≥5 Letters
|
17 Participants
|
27 Participants
|
11 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 32: Gaining ≥0 Letters
|
22 Participants
|
28 Participants
|
15 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 36: Gaining ≥15 Letters
|
7 Participants
|
11 Participants
|
6 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 36: Gaining ≥10 Letters
|
10 Participants
|
20 Participants
|
10 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 36: Gaining ≥5 Letters
|
15 Participants
|
24 Participants
|
12 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 36: Gaining ≥0 Letters
|
19 Participants
|
25 Participants
|
15 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 40: Gaining ≥15 Letters
|
8 Participants
|
11 Participants
|
5 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 40: Gaining ≥10 Letters
|
11 Participants
|
18 Participants
|
8 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 40: Gaining ≥5 Letters
|
15 Participants
|
24 Participants
|
10 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 40: Gaining ≥0 Letters
|
17 Participants
|
27 Participants
|
13 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 44: Gaining ≥15 Letters
|
7 Participants
|
13 Participants
|
6 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 44: Gaining ≥10 Letters
|
12 Participants
|
15 Participants
|
9 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 44: Gaining ≥5 Letters
|
13 Participants
|
26 Participants
|
11 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 44: Gaining ≥0 Letters
|
15 Participants
|
27 Participants
|
13 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 48: Gaining ≥15 Letters
|
7 Participants
|
10 Participants
|
6 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 48: Gaining ≥10 Letters
|
12 Participants
|
17 Participants
|
10 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 48: Gaining ≥5 Letters
|
15 Participants
|
20 Participants
|
11 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 48: Gaining ≥0 Letters
|
18 Participants
|
26 Participants
|
12 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 52: Gaining ≥15 Letters
|
7 Participants
|
13 Participants
|
6 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 52: Gaining ≥10 Letters
|
11 Participants
|
17 Participants
|
9 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 52: Gaining ≥5 Letters
|
14 Participants
|
23 Participants
|
9 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 52: Gaining ≥0 Letters
|
17 Participants
|
26 Participants
|
13 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Day 7: Gaining ≥15 Letters
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Day 7: Gaining ≥10 Letters
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Day 7: Gaining ≥5 Letters
|
11 Participants
|
16 Participants
|
6 Participants
|
|
Number and Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Day 7: Gaining ≥0 Letters
|
20 Participants
|
26 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Day 7
|
4.2 Percentage of participants
Interval 0.0 to 9.39
|
6.5 Percentage of participants
Interval 0.8 to 12.11
|
6.3 Percentage of participants
Interval 0.0 to 14.01
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 4
|
12.5 Percentage of participants
Interval 3.85 to 21.15
|
12.9 Percentage of participants
Interval 5.19 to 20.62
|
18.8 Percentage of participants
Interval 6.24 to 31.26
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 8
|
12.5 Percentage of participants
Interval 3.85 to 21.15
|
16.7 Percentage of participants
Interval 7.95 to 25.39
|
40.0 Percentage of participants
Interval 23.79 to 56.21
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 12
|
8.7 Percentage of participants
Interval 1.17 to 16.23
|
23.3 Percentage of participants
Interval 13.44 to 33.23
|
18.8 Percentage of participants
Interval 6.24 to 31.26
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 16
|
17.4 Percentage of participants
Interval 7.26 to 27.52
|
30.0 Percentage of participants
Interval 19.28 to 40.72
|
18.8 Percentage of participants
Interval 6.24 to 31.26
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 20
|
17.4 Percentage of participants
Interval 7.26 to 27.52
|
33.3 Percentage of participants
Interval 22.3 to 44.36
|
18.8 Percentage of participants
Interval 6.24 to 31.26
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 24
|
17.4 Percentage of participants
Interval 7.26 to 27.52
|
26.7 Percentage of participants
Interval 16.32 to 37.01
|
25.0 Percentage of participants
Interval 11.13 to 38.87
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 28
|
26.1 Percentage of participants
Interval 14.35 to 37.82
|
40.0 Percentage of participants
Interval 28.54 to 51.46
|
31.3 Percentage of participants
Interval 16.4 to 46.1
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 32
|
30.4 Percentage of participants
Interval 18.14 to 42.73
|
36.7 Percentage of participants
Interval 25.39 to 47.94
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 36
|
31.8 Percentage of participants
Interval 19.09 to 44.54
|
37.9 Percentage of participants
Interval 26.38 to 49.48
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 40
|
38.1 Percentage of participants
Interval 24.51 to 51.68
|
39.3 Percentage of participants
Interval 27.46 to 51.11
|
33.3 Percentage of participants
Interval 17.73 to 48.93
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 44
|
35.0 Percentage of participants
Interval 21.33 to 48.67
|
44.8 Percentage of participants
Interval 32.99 to 56.66
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 48
|
33.3 Percentage of participants
Interval 20.15 to 46.52
|
35.7 Percentage of participants
Interval 24.11 to 47.32
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants Gaining ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 52
|
33.3 Percentage of participants
Interval 20.15 to 46.52
|
46.4 Percentage of participants
Interval 34.35 to 58.51
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a loss in BCVA letter score from baseline indicates worsening in visual acuity. This analysis was performed on observed data.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 12: Not Losing ≥15 Letters
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 28: Not Losing ≥10 Letters
|
23 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 32: Not Losing ≥10 Letters
|
23 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 32: Not Losing ≥0 Letters
|
20 Participants
|
28 Participants
|
13 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 36: Not Losing ≥5 Letters
|
20 Participants
|
27 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 40: Not Losing ≥5 Letters
|
19 Participants
|
27 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Day 7: Not Losing ≥15 Letters
|
24 Participants
|
31 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Day 7: Not Losing ≥10 Letters
|
24 Participants
|
31 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Day 7: Not Losing ≥5 Letters
|
21 Participants
|
29 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Day 7: Not Losing ≥0 Letters
|
18 Participants
|
24 Participants
|
10 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 4: Not Losing ≥15 Letters
|
24 Participants
|
31 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 4: Not Losing ≥10 Letters
|
24 Participants
|
31 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 4: Not Losing ≥5 Letters
|
23 Participants
|
31 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 4: Not Losing ≥0 Letters
|
18 Participants
|
29 Participants
|
13 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 8: Not Losing ≥15 Letters
|
23 Participants
|
30 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 8: Not Losing ≥10 Letters
|
23 Participants
|
30 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 8: Not Losing ≥5 Letters
|
22 Participants
|
29 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 8: Not Losing ≥0 Letters
|
20 Participants
|
28 Participants
|
13 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 12: Not Losing ≥10 Letters
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 12: Not Losing ≥5 Letters
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 12: Not Losing ≥0 Letters
|
19 Participants
|
28 Participants
|
14 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 16: Not Losing ≥15 Letters
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 16: Not Losing ≥10 Letters
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 16: Not Losing ≥5 Letters
|
22 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 16: Not Losing ≥0 Letters
|
19 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 20: Not Losing ≥15 Letters
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 20: Not Losing ≥10 Letters
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 20: Not Losing ≥5 Letters
|
22 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 20: Not Losing ≥0 Letters
|
19 Participants
|
24 Participants
|
14 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 24: Not Losing ≥15 Letters
|
23 Participants
|
30 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 24: Not Losing ≥10 Letters
|
22 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 24: Not Losing ≥5 Letters
|
22 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 24: Not Losing ≥0 Letters
|
19 Participants
|
27 Participants
|
14 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 28: Not Losing ≥15 Letters
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 28: Not Losing ≥5 Letters
|
21 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 28: Not Losing ≥0 Letters
|
20 Participants
|
27 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 32: Not Losing ≥15 Letters
|
23 Participants
|
29 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 32: Not Losing ≥5 Letters
|
22 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 36: Not Losing ≥15 Letters
|
21 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 36: Not Losing ≥10 Letters
|
21 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 36: Not Losing ≥0 Letters
|
19 Participants
|
25 Participants
|
14 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 40: Not Losing ≥15 Letters
|
20 Participants
|
27 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 40: Not Losing ≥10 Letters
|
20 Participants
|
27 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 40: Not Losing ≥0 Letters
|
17 Participants
|
25 Participants
|
12 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 44: Not Losing ≥15 Letters
|
20 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 44: Not Losing ≥10 Letters
|
20 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 44: Not Losing ≥5 Letters
|
17 Participants
|
28 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 44: Not Losing ≥0 Letters
|
14 Participants
|
27 Participants
|
12 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 48: Not Losing ≥15 Letters
|
21 Participants
|
27 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 48: Not Losing ≥10 Letters
|
20 Participants
|
27 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 48: Not Losing ≥5 Letters
|
19 Participants
|
27 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 48: Not Losing ≥0 Letters
|
16 Participants
|
25 Participants
|
11 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 52: Not Losing ≥15 Letters
|
21 Participants
|
27 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 52: Not Losing ≥10 Letters
|
21 Participants
|
27 Participants
|
16 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 52: Not Losing ≥5 Letters
|
20 Participants
|
27 Participants
|
15 Participants
|
|
Number and Percentage of Participants Not Losing ≥15, ≥10, ≥5, or ≥0 Letters From Baseline in BCVA at Specified Timepoints
Week 52: Not Losing ≥0 Letters
|
16 Participants
|
26 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 12
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
96.7 Percentage of participants
Interval 92.47 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Day 7
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 4
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 8
|
95.8 Percentage of participants
Interval 90.61 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 16
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
96.7 Percentage of participants
Interval 92.47 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 20
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
96.7 Percentage of participants
Interval 92.47 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 24
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 28
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
96.7 Percentage of participants
Interval 92.47 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 32
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
96.7 Percentage of participants
Interval 92.47 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 36
|
95.5 Percentage of participants
Interval 89.76 to 100.0
|
96.6 Percentage of participants
Interval 92.21 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 40
|
95.2 Percentage of participants
Interval 89.28 to 100.0
|
96.4 Percentage of participants
Interval 91.93 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 44
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
96.6 Percentage of participants
Interval 92.21 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 48
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
96.4 Percentage of participants
Interval 91.93 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Not Losing ≥15 Letters From Baseline in BCVA at Specified Timepoints
Week 52
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
96.4 Percentage of participants
Interval 91.93 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 28
|
56.5 Percentage of participants
Interval 43.27 to 69.77
|
73.3 Percentage of participants
Interval 62.99 to 83.68
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 12
|
43.5 Percentage of participants
Interval 30.23 to 56.73
|
73.3 Percentage of participants
Interval 62.99 to 83.68
|
31.3 Percentage of participants
Interval 16.4 to 46.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 16
|
52.2 Percentage of participants
Interval 38.83 to 65.52
|
70.0 Percentage of participants
Interval 59.28 to 80.72
|
43.8 Percentage of participants
Interval 27.86 to 59.64
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 20
|
47.8 Percentage of participants
Interval 34.48 to 61.17
|
73.3 Percentage of participants
Interval 62.99 to 83.68
|
50.0 Percentage of participants
Interval 33.98 to 66.02
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 24
|
56.5 Percentage of participants
Interval 43.27 to 69.77
|
70.0 Percentage of participants
Interval 59.28 to 80.72
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 32
|
60.9 Percentage of participants
Interval 47.83 to 73.91
|
70.0 Percentage of participants
Interval 59.28 to 80.72
|
43.8 Percentage of participants
Interval 27.86 to 59.64
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 36
|
59.1 Percentage of participants
Interval 45.66 to 72.52
|
75.9 Percentage of participants
Interval 65.68 to 86.05
|
43.8 Percentage of participants
Interval 27.86 to 59.64
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 40
|
61.9 Percentage of participants
Interval 48.32 to 75.49
|
78.6 Percentage of participants
Interval 68.63 to 88.51
|
40.0 Percentage of participants
Interval 23.79 to 56.21
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 44
|
50.0 Percentage of participants
Interval 35.67 to 64.33
|
72.4 Percentage of participants
Interval 61.78 to 83.05
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 48
|
57.1 Percentage of participants
Interval 43.3 to 70.98
|
75.0 Percentage of participants
Interval 64.51 to 85.49
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 52
|
57.1 Percentage of participants
Interval 43.3 to 70.98
|
71.4 Percentage of participants
Interval 60.49 to 82.37
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Day 7
|
20.8 Percentage of participants
Interval 10.21 to 31.46
|
45.2 Percentage of participants
Interval 33.71 to 56.62
|
18.8 Percentage of participants
Interval 6.24 to 31.26
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 4
|
45.8 Percentage of participants
Interval 32.8 to 58.87
|
51.6 Percentage of participants
Interval 40.11 to 63.12
|
25.0 Percentage of participants
Interval 11.13 to 38.87
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Week 8
|
41.7 Percentage of participants
Interval 28.77 to 54.56
|
70.0 Percentage of participants
Interval 59.28 to 80.72
|
20.0 Percentage of participants
Interval 6.76 to 33.24
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints
Baseline
|
12.5 Percentage of participants
Interval 3.85 to 21.15
|
22.6 Percentage of participants
Interval 12.96 to 32.2
|
18.8 Percentage of participants
Interval 6.24 to 31.26
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Baseline
|
8.3 Percentage of participants
Interval 1.1 to 15.56
|
3.2 Percentage of participants
Interval 0.0 to 7.29
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Day 7
|
4.2 Percentage of participants
Interval 0.0 to 9.39
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 4
|
4.2 Percentage of participants
Interval 0.0 to 9.39
|
3.2 Percentage of participants
Interval 0.0 to 7.29
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 8
|
8.3 Percentage of participants
Interval 1.1 to 15.56
|
6.7 Percentage of participants
Interval 0.83 to 12.5
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 12
|
4.3 Percentage of participants
Interval 0.0 to 9.8
|
6.7 Percentage of participants
Interval 0.83 to 12.5
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 16
|
4.3 Percentage of participants
Interval 0.0 to 9.8
|
3.3 Percentage of participants
Interval 0.0 to 7.53
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 20
|
4.3 Percentage of participants
Interval 0.0 to 9.8
|
6.7 Percentage of participants
Interval 0.83 to 12.5
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 36
|
4.5 Percentage of participants
Interval 0.0 to 10.24
|
3.4 Percentage of participants
Interval 0.0 to 7.79
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 24
|
4.3 Percentage of participants
Interval 0.0 to 9.8
|
6.7 Percentage of participants
Interval 0.83 to 12.5
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 28
|
4.3 Percentage of participants
Interval 0.0 to 9.8
|
3.3 Percentage of participants
Interval 0.0 to 7.53
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 32
|
4.3 Percentage of participants
Interval 0.0 to 9.8
|
3.3 Percentage of participants
Interval 0.0 to 7.53
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 40
|
0 Percentage of participants
Interval 0.0 to 0.0
|
3.6 Percentage of participants
Interval 0.0 to 8.07
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 44
|
5.0 Percentage of participants
Interval 0.0 to 11.25
|
3.4 Percentage of participants
Interval 0.0 to 7.79
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 48
|
4.8 Percentage of participants
Interval 0.0 to 10.72
|
3.6 Percentage of participants
Interval 0.0 to 8.07
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints
Week 52
|
4.8 Percentage of participants
Interval 0.0 to 10.72
|
3.6 Percentage of participants
Interval 0.0 to 8.07
|
0 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment.
Central foveal thickness (CFT) was defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea, and it was measured using spectral domain optical coherence tomography (SD-OCT). The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline CFT.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Day 7
|
-93.56 microns (μm)
Interval -109.05 to -78.07
|
-94.31 microns (μm)
Interval -107.78 to -80.83
|
-76.01 microns (μm)
Interval -95.07 to -56.95
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 4
|
-132.27 microns (μm)
Interval -146.13 to -118.41
|
-130.11 microns (μm)
Interval -142.37 to -117.85
|
-122.07 microns (μm)
Interval -139.47 to -104.67
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 40
|
-137.54 microns (μm)
Interval -156.68 to -118.4
|
-123.31 microns (μm)
Interval -140.2 to -106.42
|
-137.99 microns (μm)
Interval -161.27 to -114.71
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 48
|
-125.93 microns (μm)
Interval -145.69 to -106.17
|
-121.67 microns (μm)
Interval -139.07 to -104.26
|
-130.76 microns (μm)
Interval -154.93 to -106.58
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 52
|
-140.95 microns (μm)
Interval -157.06 to -124.85
|
-134.99 microns (μm)
Interval -149.21 to -120.76
|
-136.10 microns (μm)
Interval -155.98 to -116.23
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 8
|
-134.47 microns (μm)
Interval -148.3 to -120.65
|
-136.15 microns (μm)
Interval -148.42 to -123.89
|
-127.64 microns (μm)
Interval -145.03 to -110.24
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 12
|
-142.26 microns (μm)
Interval -157.01 to -127.52
|
-139.63 microns (μm)
Interval -152.66 to -126.59
|
-126.63 microns (μm)
Interval -145.03 to -108.24
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 16
|
-134.94 microns (μm)
Interval -150.26 to -119.63
|
-137.81 microns (μm)
Interval -151.37 to -124.25
|
-120.48 microns (μm)
Interval -139.55 to -101.4
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 20
|
-125.05 microns (μm)
Interval -143.75 to -106.35
|
-125.35 microns (μm)
Interval -141.86 to -108.84
|
-120.70 microns (μm)
Interval -143.69 to -97.7
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 24
|
-121.13 microns (μm)
Interval -140.94 to -101.31
|
-108.66 microns (μm)
Interval -126.14 to -91.17
|
-131.29 microns (μm)
Interval -155.62 to -106.96
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 28
|
-131.58 microns (μm)
Interval -148.18 to -114.99
|
-116.76 microns (μm)
Interval -131.41 to -102.12
|
-130.29 microns (μm)
Interval -150.8 to -109.78
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 32
|
-127.85 microns (μm)
Interval -149.31 to -106.38
|
-123.44 microns (μm)
Interval -142.37 to -104.51
|
-134.29 microns (μm)
Interval -160.61 to -107.97
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 36
|
-114.27 microns (μm)
Interval -134.82 to -93.71
|
-114.97 microns (μm)
Interval -133.02 to -96.92
|
-149.26 microns (μm)
Interval -174.17 to -124.35
|
|
Mean Change From Baseline in Central Foveal Thickness (CFT) at Specified Timepoints
Week 44
|
-135.30 microns (μm)
Interval -154.78 to -115.82
|
-110.26 microns (μm)
Interval -127.23 to -93.3
|
-135.70 microns (μm)
Interval -159.16 to -112.23
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment.
Central subfield thickness (CST) was defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield, and it was measured using spectral domain optical coherence tomography (SD-OCT). The analysis was performed using a Mixed Model for Repeated Measurement (MMRM) model, which included an unstructured covariance and the categorical covariates of treatment group, visit, and visit by treatment group interaction and the continuous covariate of baseline CST.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 12
|
-134.70 microns (μm)
Interval -148.96 to -120.44
|
-132.87 microns (μm)
Interval -145.53 to -120.2
|
-122.39 microns (μm)
Interval -139.93 to -104.85
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 20
|
-114.97 microns (μm)
Interval -131.83 to -98.12
|
-118.89 microns (μm)
Interval -133.77 to -104.0
|
-120.77 microns (μm)
Interval -141.28 to -100.25
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 40
|
-138.55 microns (μm)
Interval -154.04 to -123.05
|
-121.34 microns (μm)
Interval -135.07 to -107.62
|
-126.32 microns (μm)
Interval -145.2 to -107.44
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 52
|
-138.53 microns (μm)
Interval -152.42 to -124.65
|
-122.53 microns (μm)
Interval -134.81 to -110.25
|
-129.89 microns (μm)
Interval -146.74 to -113.04
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Day 7
|
-88.87 microns (μm)
Interval -100.4 to -77.34
|
-84.23 microns (μm)
Interval -94.35 to -74.11
|
-80.08 microns (μm)
Interval -94.15 to -66.01
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 4
|
-127.20 microns (μm)
Interval -139.69 to -114.72
|
-123.10 microns (μm)
Interval -134.18 to -112.02
|
-111.58 microns (μm)
Interval -126.99 to -96.17
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 8
|
-132.03 microns (μm)
Interval -145.4 to -118.67
|
-131.25 microns (μm)
Interval -143.13 to -119.37
|
-117.04 microns (μm)
Interval -133.54 to -100.53
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 16
|
-132.96 microns (μm)
Interval -147.69 to -118.23
|
-132.50 microns (μm)
Interval -145.58 to -119.42
|
-122.70 microns (μm)
Interval -140.81 to -104.6
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 24
|
-101.62 microns (μm)
Interval -119.69 to -83.54
|
-99.35 microns (μm)
Interval -115.29 to -83.42
|
-121.33 microns (μm)
Interval -143.26 to -99.4
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 28
|
-129.68 microns (μm)
Interval -144.4 to -114.95
|
-109.89 microns (μm)
Interval -122.91 to -96.87
|
-127.95 microns (μm)
Interval -145.93 to -109.98
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 32
|
-121.10 microns (μm)
Interval -139.5 to -102.71
|
-116.35 microns (μm)
Interval -132.57 to -100.14
|
-127.20 microns (μm)
Interval -149.56 to -104.85
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 36
|
-101.98 microns (μm)
Interval -121.6 to -82.36
|
-102.69 microns (μm)
Interval -119.96 to -85.42
|
-118.89 microns (μm)
Interval -142.63 to -95.15
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 44
|
-130.50 microns (μm)
Interval -146.19 to -114.81
|
-103.31 microns (μm)
Interval -117.04 to -89.57
|
-124.89 microns (μm)
Interval -143.71 to -106.08
|
|
Mean Change From Baseline in Central Subfield Thickness (CST) at Specified Timepoints
Week 48
|
-126.45 microns (μm)
Interval -145.58 to -107.33
|
-102.30 microns (μm)
Interval -119.14 to -85.47
|
-123.89 microns (μm)
Interval -147.01 to -100.77
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Intraretinal fluid was defined as the presence of fluid within the retina. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Baseline
|
4.2 Percentage of participants
Interval 0.0 to 9.39
|
29.0 Percentage of participants
Interval 18.58 to 39.48
|
18.8 Percentage of participants
Interval 6.24 to 31.26
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 12
|
39.1 Percentage of participants
Interval 26.09 to 52.17
|
43.3 Percentage of participants
Interval 31.74 to 54.93
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 16
|
47.8 Percentage of participants
Interval 34.48 to 61.17
|
50.0 Percentage of participants
Interval 38.3 to 61.7
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 28
|
26.1 Percentage of participants
Interval 14.35 to 37.82
|
53.3 Percentage of participants
Interval 41.66 to 65.01
|
31.3 Percentage of participants
Interval 16.4 to 46.1
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 44
|
55.0 Percentage of participants
Interval 40.74 to 69.26
|
48.3 Percentage of participants
Interval 36.38 to 60.17
|
43.8 Percentage of participants
Interval 27.86 to 59.64
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 48
|
38.1 Percentage of participants
Interval 24.51 to 51.68
|
53.6 Percentage of participants
Interval 41.49 to 65.65
|
62.5 Percentage of participants
Interval 46.99 to 78.01
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Day 7
|
21.7 Percentage of participants
Interval 10.72 to 32.76
|
38.7 Percentage of participants
Interval 27.5 to 49.92
|
25.0 Percentage of participants
Interval 11.13 to 38.87
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 4
|
29.2 Percentage of participants
Interval 17.28 to 41.06
|
48.4 Percentage of participants
Interval 36.88 to 59.89
|
50.0 Percentage of participants
Interval 33.98 to 66.02
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 8
|
33.3 Percentage of participants
Interval 21.0 to 45.67
|
46.7 Percentage of participants
Interval 34.99 to 58.34
|
26.7 Percentage of participants
Interval 12.03 to 41.3
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 20
|
43.5 Percentage of participants
Interval 30.23 to 56.73
|
53.3 Percentage of participants
Interval 41.66 to 65.01
|
18.8 Percentage of participants
Interval 6.24 to 31.26
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 24
|
30.4 Percentage of participants
Interval 18.14 to 42.73
|
50.0 Percentage of participants
Interval 38.3 to 61.7
|
31.3 Percentage of participants
Interval 16.4 to 46.1
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 32
|
26.1 Percentage of participants
Interval 14.35 to 37.82
|
50.0 Percentage of participants
Interval 38.3 to 61.7
|
31.3 Percentage of participants
Interval 16.4 to 46.1
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 36
|
31.8 Percentage of participants
Interval 19.09 to 44.54
|
44.8 Percentage of participants
Interval 32.99 to 56.66
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 40
|
38.1 Percentage of participants
Interval 24.51 to 51.68
|
57.1 Percentage of participants
Interval 45.16 to 69.13
|
33.3 Percentage of participants
Interval 17.73 to 48.93
|
|
Percentage of Participants With No Intraretinal Fluid at Specified Timepoints
Week 52
|
38.1 Percentage of participants
Interval 24.51 to 51.68
|
35.7 Percentage of participants
Interval 24.11 to 47.32
|
62.5 Percentage of participants
Interval 46.99 to 78.01
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Subretinal fluid was defined as the presence of fluid between the retina and the retinal pigment epithelium. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 4
|
70.8 Percentage of participants
Interval 58.94 to 82.72
|
77.4 Percentage of participants
Interval 67.8 to 87.04
|
62.5 Percentage of participants
Interval 46.99 to 78.01
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Baseline
|
20.8 Percentage of participants
Interval 10.21 to 31.46
|
12.9 Percentage of participants
Interval 5.19 to 20.62
|
25.0 Percentage of participants
Interval 11.13 to 38.87
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 16
|
87.0 Percentage of participants
Interval 77.96 to 95.96
|
96.7 Percentage of participants
Interval 92.47 to 100.0
|
75.0 Percentage of participants
Interval 61.13 to 88.87
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 40
|
81.0 Percentage of participants
Interval 69.97 to 91.93
|
89.3 Percentage of participants
Interval 81.79 to 96.78
|
86.7 Percentage of participants
Interval 75.42 to 97.91
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 44
|
80.0 Percentage of participants
Interval 68.54 to 91.46
|
75.9 Percentage of participants
Interval 65.68 to 86.05
|
81.3 Percentage of participants
Interval 68.74 to 93.76
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 48
|
71.4 Percentage of participants
Interval 58.79 to 84.06
|
64.3 Percentage of participants
Interval 52.68 to 75.89
|
87.5 Percentage of participants
Interval 76.9 to 98.1
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Day 7
|
39.1 Percentage of participants
Interval 26.09 to 52.17
|
29.0 Percentage of participants
Interval 18.58 to 39.48
|
31.3 Percentage of participants
Interval 16.4 to 46.1
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 8
|
83.3 Percentage of participants
Interval 73.58 to 93.08
|
86.7 Percentage of participants
Interval 78.71 to 94.62
|
80.0 Percentage of participants
Interval 66.76 to 93.24
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 12
|
91.3 Percentage of participants
Interval 83.77 to 98.83
|
90.0 Percentage of participants
Interval 82.98 to 97.02
|
75.0 Percentage of participants
Interval 61.13 to 88.87
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 20
|
69.6 Percentage of participants
Interval 57.27 to 81.86
|
70.0 Percentage of participants
Interval 59.28 to 80.72
|
87.5 Percentage of participants
Interval 76.9 to 98.1
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 24
|
65.2 Percentage of participants
Interval 52.49 to 77.94
|
66.7 Percentage of participants
Interval 55.64 to 77.7
|
75.0 Percentage of participants
Interval 61.13 to 88.87
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 28
|
91.3 Percentage of participants
Interval 83.77 to 98.83
|
70.0 Percentage of participants
Interval 59.28 to 80.72
|
75.0 Percentage of participants
Interval 61.13 to 88.87
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 32
|
69.6 Percentage of participants
Interval 57.27 to 81.86
|
80.0 Percentage of participants
Interval 70.64 to 89.36
|
68.8 Percentage of participants
Interval 53.9 to 83.6
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 36
|
68.2 Percentage of participants
Interval 55.46 to 80.91
|
72.4 Percentage of participants
Interval 61.78 to 83.05
|
81.3 Percentage of participants
Interval 68.74 to 93.76
|
|
Percentage of Participants With No Subretinal Fluid at Specified Timepoints
Week 52
|
81.0 Percentage of participants
Interval 69.97 to 91.93
|
89.3 Percentage of participants
Interval 81.79 to 96.78
|
87.5 Percentage of participants
Interval 76.9 to 98.1
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Cysts were defined as the presence of cystoid space (fluid) in the retina. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 16
|
91.3 Percentage of participants
Interval 83.77 to 98.83
|
83.3 Percentage of participants
Interval 74.61 to 92.05
|
75.0 Percentage of participants
Interval 61.13 to 88.87
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 20
|
91.3 Percentage of participants
Interval 83.77 to 98.83
|
80.0 Percentage of participants
Interval 70.64 to 89.36
|
68.8 Percentage of participants
Interval 53.9 to 83.6
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 24
|
73.9 Percentage of participants
Interval 62.18 to 85.65
|
76.7 Percentage of participants
Interval 66.77 to 86.56
|
68.8 Percentage of participants
Interval 53.9 to 83.6
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 28
|
95.7 Percentage of participants
Interval 90.2 to 100.0
|
70.0 Percentage of participants
Interval 59.28 to 80.72
|
68.8 Percentage of participants
Interval 53.9 to 83.6
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 32
|
82.6 Percentage of participants
Interval 72.48 to 92.74
|
76.7 Percentage of participants
Interval 66.77 to 86.56
|
75.0 Percentage of participants
Interval 61.13 to 88.87
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 48
|
95.2 Percentage of participants
Interval 89.28 to 100.0
|
85.7 Percentage of participants
Interval 77.24 to 94.19
|
87.5 Percentage of participants
Interval 76.9 to 98.1
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 52
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
78.6 Percentage of participants
Interval 68.63 to 88.51
|
87.5 Percentage of participants
Interval 76.9 to 98.1
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 8
|
83.3 Percentage of participants
Interval 73.58 to 93.08
|
83.3 Percentage of participants
Interval 74.61 to 92.05
|
86.7 Percentage of participants
Interval 75.42 to 97.91
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 36
|
77.3 Percentage of participants
Interval 65.82 to 88.72
|
79.3 Percentage of participants
Interval 69.67 to 88.95
|
68.8 Percentage of participants
Interval 53.9 to 83.6
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 40
|
85.7 Percentage of participants
Interval 75.93 to 95.5
|
78.6 Percentage of participants
Interval 68.63 to 88.51
|
80.0 Percentage of participants
Interval 66.76 to 93.24
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 44
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
72.4 Percentage of participants
Interval 61.78 to 83.05
|
87.5 Percentage of participants
Interval 76.9 to 98.1
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Baseline
|
33.3 Percentage of participants
Interval 21.0 to 45.67
|
48.4 Percentage of participants
Interval 36.88 to 59.89
|
37.5 Percentage of participants
Interval 21.99 to 53.01
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Day 7
|
65.2 Percentage of participants
Interval 52.49 to 77.94
|
83.9 Percentage of participants
Interval 75.41 to 92.34
|
75.0 Percentage of participants
Interval 61.13 to 88.87
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 4
|
87.5 Percentage of participants
Interval 78.85 to 96.15
|
87.1 Percentage of participants
Interval 79.38 to 94.81
|
87.5 Percentage of participants
Interval 76.9 to 98.1
|
|
Percentage of Participants With No Cysts at Specified Timepoints
Week 12
|
91.3 Percentage of participants
Interval 83.77 to 98.83
|
83.3 Percentage of participants
Interval 74.61 to 92.05
|
68.8 Percentage of participants
Interval 53.9 to 83.6
|
SECONDARY outcome
Timeframe: Baseline, Day 7, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
The absence of intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Pigment epithelial detachment was defined as the presence of a detachment of the pigment epithelium from the Bruch's membrane. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis was performed on observed data. The 80% confidence intervals were calculated using the Wald method.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 32
|
13.0 Percentage of participants
Interval 4.04 to 22.04
|
23.3 Percentage of participants
Interval 13.44 to 33.23
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Day 7
|
13.0 Percentage of participants
Interval 4.04 to 22.04
|
29.0 Percentage of participants
Interval 18.58 to 39.48
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 12
|
8.7 Percentage of participants
Interval 1.17 to 16.23
|
26.7 Percentage of participants
Interval 16.32 to 37.01
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 16
|
8.7 Percentage of participants
Interval 1.17 to 16.23
|
23.3 Percentage of participants
Interval 13.44 to 33.23
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 28
|
13.0 Percentage of participants
Interval 4.04 to 22.04
|
20.0 Percentage of participants
Interval 10.64 to 29.36
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 40
|
4.8 Percentage of participants
Interval 0.0 to 10.72
|
21.4 Percentage of participants
Interval 11.49 to 31.37
|
13.3 Percentage of participants
Interval 2.09 to 24.58
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 44
|
5.0 Percentage of participants
Interval 0.0 to 11.25
|
17.2 Percentage of participants
Interval 8.25 to 26.23
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 36
|
4.5 Percentage of participants
Interval 0.0 to 10.24
|
20.7 Percentage of participants
Interval 11.05 to 30.33
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 48
|
9.5 Percentage of participants
Interval 1.31 to 17.73
|
17.9 Percentage of participants
Interval 8.58 to 27.13
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 52
|
14.3 Percentage of participants
Interval 4.5 to 24.07
|
14.3 Percentage of participants
Interval 5.81 to 22.76
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Baseline
|
8.3 Percentage of participants
Interval 1.1 to 15.56
|
29.0 Percentage of participants
Interval 18.58 to 39.48
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 4
|
8.3 Percentage of participants
Interval 1.1 to 15.56
|
22.6 Percentage of participants
Interval 12.96 to 32.2
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 8
|
8.3 Percentage of participants
Interval 1.1 to 15.56
|
23.3 Percentage of participants
Interval 13.44 to 33.23
|
13.3 Percentage of participants
Interval 2.09 to 24.58
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 20
|
13.0 Percentage of participants
Interval 4.04 to 22.04
|
23.3 Percentage of participants
Interval 13.44 to 33.23
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
|
Percentage of Participants With No Pigment Epithelial Detachment at Specified Timepoints
Week 24
|
13.0 Percentage of participants
Interval 4.04 to 22.04
|
23.3 Percentage of participants
Interval 13.44 to 33.23
|
12.5 Percentage of participants
Interval 1.9 to 23.1
|
SECONDARY outcome
Timeframe: Baseline, Week 40, Week 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Mean Baseline Value and Mean Change From Baseline of Total Area of Choroidal Neovascularization (CNV) at Week 40 and Week 52
Baseline (BL): Absolute Value
|
7.1 millimetres squared (mm^2)
Standard Deviation 3.9
|
5.9 millimetres squared (mm^2)
Standard Deviation 3.8
|
7.3 millimetres squared (mm^2)
Standard Deviation 2.9
|
|
Mean Baseline Value and Mean Change From Baseline of Total Area of Choroidal Neovascularization (CNV) at Week 40 and Week 52
Change from BL at Week 40
|
-4.7 millimetres squared (mm^2)
Standard Deviation 4.3
|
-3.9 millimetres squared (mm^2)
Standard Deviation 3.7
|
-4.6 millimetres squared (mm^2)
Standard Deviation 3.5
|
|
Mean Baseline Value and Mean Change From Baseline of Total Area of Choroidal Neovascularization (CNV) at Week 40 and Week 52
Change from BL at Week 52
|
-5.4 millimetres squared (mm^2)
Standard Deviation 4.0
|
-4.2 millimetres squared (mm^2)
Standard Deviation 3.4
|
-4.5 millimetres squared (mm^2)
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline, Week 40, Week 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
The total area of choroidal neovascularization (CNV) component (i.e., total area of CNV membrane) was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Mean Baseline Value and Mean Change From Baseline of Total Area of CNV Component at Week 40 and Week 52
Baseline (BL): Absolute Value
|
7.0 millimetres squared (mm^2)
Standard Deviation 3.8
|
5.8 millimetres squared (mm^2)
Standard Deviation 3.6
|
7.1 millimetres squared (mm^2)
Standard Deviation 3.0
|
|
Mean Baseline Value and Mean Change From Baseline of Total Area of CNV Component at Week 40 and Week 52
Change from BL at Week 40
|
-5.0 millimetres squared (mm^2)
Standard Deviation 4.2
|
-4.0 millimetres squared (mm^2)
Standard Deviation 4.0
|
-4.7 millimetres squared (mm^2)
Standard Deviation 3.4
|
|
Mean Baseline Value and Mean Change From Baseline of Total Area of CNV Component at Week 40 and Week 52
Change from BL at Week 52
|
-5.6 millimetres squared (mm^2)
Standard Deviation 4.0
|
-4.3 millimetres squared (mm^2)
Standard Deviation 3.7
|
-4.8 millimetres squared (mm^2)
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline, Week 40, Week 52Population: Efficacy population: participants grouped according to their assigned treatment. This analysis of observed data included participants with non-missing assessments at each timepoint.
The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Mean Baseline Value and Mean Change From Baseline of Total Area of Leakage at Week 40 and Week 52
Baseline (BL): Absolute Value
|
7.0 millimetres squared (mm^2)
Standard Deviation 3.8
|
6.1 millimetres squared (mm^2)
Standard Deviation 3.4
|
7.6 millimetres squared (mm^2)
Standard Deviation 2.9
|
|
Mean Baseline Value and Mean Change From Baseline of Total Area of Leakage at Week 40 and Week 52
Change from BL at Week 40
|
-5.0 millimetres squared (mm^2)
Standard Deviation 4.2
|
-4.3 millimetres squared (mm^2)
Standard Deviation 3.9
|
-5.3 millimetres squared (mm^2)
Standard Deviation 3.7
|
|
Mean Baseline Value and Mean Change From Baseline of Total Area of Leakage at Week 40 and Week 52
Change from BL at Week 52
|
-5.6 millimetres squared (mm^2)
Standard Deviation 4.0
|
-4.6 millimetres squared (mm^2)
Standard Deviation 3.5
|
-5.3 millimetres squared (mm^2)
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Predose at Baseline (Day 1), Weeks 16, 24, 28, 44, and 52Population: Safety Population: participants who received at least one dose of study treatment, grouped according to treatment received. The analysis only included participants who received treatment with faricimab (i.e., 0.5 mg Ranibizumab Q4W arm was excluded) and had evaluable samples at baseline and/or any post-baseline timepoint.
Blood samples were obtained for measurement of anti-drug antibodies (ADAs) to faricimab by a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline
ADA Negative to ADA Positive
|
1 Participants
|
4 Participants
|
—
|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline
Missing to ADA Positive
|
1 Participants
|
0 Participants
|
—
|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline
ADA Negative to ADA Negative
|
21 Participants
|
25 Participants
|
—
|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline
Missing to ADA Negative
|
0 Participants
|
1 Participants
|
—
|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies (ADA) to Faricimab at Anytime Post-Baseline
No Post-Baseline ADA Assessment
|
1 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline until 28 days after the last dose of study drug (up to 52 weeks)Population: Safety Population: participants who received at least one dose of the study treatment, grouped according to treatment received.
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. The investigator independently assessed the seriousness and severity for each AE. Severity was graded according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Severity and seriousness are not synonymous; regardless of severity, some AEs may have also met seriousness criteria.
Outcome measures
| Measure |
6 mg Faricimab Q12W
n=24 Participants
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 Participants
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 Participants
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
AE Leading to Withdrawal from Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
Any Adverse Event (AE)
|
18 Participants
|
23 Participants
|
13 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
Serious AE (SAE)
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
SAE Leading to Withdrawal from Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
SAE Leading to Dose Modification/Interruption
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
Serious Ocular AE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
AE Leading to Dose Modification/Interruption
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
Serious Non-Ocular AE
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
Ocular AE in the Study Eye
|
9 Participants
|
11 Participants
|
8 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
Ocular AE in the Fellow Eye
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Safety Summary: Number and Percentage of Participants With at Least One Adverse Event
Non-Ocular AE
|
14 Participants
|
20 Participants
|
9 Participants
|
Adverse Events
6 mg Faricimab Q12W
Serious events: 4 serious events
Other events: 18 other events
Deaths: 1 deaths
6 mg Faricimab Q16W
Serious events: 3 serious events
Other events: 22 other events
Deaths: 2 deaths
0.5 mg Ranibizumab Q4W
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
6 mg Faricimab Q12W
n=24 participants at risk
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 participants at risk
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 participants at risk
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Cardiac disorders
Acute left ventricular failure
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Cardiac disorders
Coronary artery disease
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Ear and labyrinth disorders
Vertigo
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Sepsis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Nervous system disorders
Ischaemic stroke
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Psychiatric disorders
Mental status changes
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
Other adverse events
| Measure |
6 mg Faricimab Q12W
n=24 participants at risk
6 mg faricimab was given by intravitreal (IVT) injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by 6 mg faricimab IVT injection once every 12 weeks (Q12W) from Week 24 up to Week 48 (injections at Weeks 24, 36, and 48; 3 injections).
|
6 mg Faricimab Q16W
n=31 participants at risk
6 mg faricimab was administered by IVT injection once every 4 weeks (Q4W) up to Week 12 (4 injections), followed by no doses up to Week 24 when a protocol-defined assessment of disease activity was performed. Participants with disease activity at Week 24 initiated 6 mg faricimab IVT Q12W dosing, and participants without disease activity at Week 24 initiated 6 mg faricimab IVT once every 16 weeks (Q16W) dosing for the remainder of the study.
|
0.5 mg Ranibizumab Q4W
n=16 participants at risk
0.5 mg of ranibizumab was administered by IVT injection once every 4 weeks (Q4W) for 48 weeks (13 injections).
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
20.8%
5/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
12.9%
4/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
25.0%
4/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Neovascular age-related macular degeneration
|
12.5%
3/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
12.5%
2/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Eye pain
|
8.3%
2/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
12.5%
2/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Retinal haemorrhage
|
8.3%
2/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
12.5%
2/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Cataract
|
8.3%
2/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Choroidal neovascularisation
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Dry eye
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Maculopathy
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.5%
2/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Ocular discomfort
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Vitreous detachment
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Vitreous floaters
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Macular oedema
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Optic disc haemorrhage
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Vision blurred
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
4/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.5%
2/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.5%
2/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Influenza
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.5%
2/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
16.1%
5/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.5%
2/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.5%
2/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
General disorders
Pain
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
General disorders
Cyst
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Investigations
Biopsy palate
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
8.3%
2/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Psychiatric disorders
Anxiety
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.5%
2/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.5%
2/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Nervous system disorders
Headache
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Anterior chamber flare
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Chalazion
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Eye irritation
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Eye pruritus
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Iritis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Subretinal fibrosis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Visual acuity reduced
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Catheter site infection
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Ear infection
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Joint abscess
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Mycobacterium avium complex infection
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Rhinitis
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Infections and infestations
Urethritis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Gastrointestinal disorders
Hiatus hernia
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
General disorders
Fatigue
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
General disorders
Inflammatory pain
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Investigations
Blood sodium decreased
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Investigations
Catheterisation cardiac
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Cardiac disorders
Arrhythmia
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Cardiac disorders
Cardiac failure congestive
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Nervous system disorders
Cerebral infarction
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Hepatobiliary disorders
Cholecystitis
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Immune system disorders
Hypersensitivity
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Chorioretinal atrophy
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Retinal drusen
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Eye disorders
Vitreous disorder
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
4.2%
1/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Vascular disorders
Aneurysm
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
3.2%
1/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
|
Investigations
Ophthalmological examination abnormal
|
0.00%
0/24 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
0.00%
0/31 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
6.2%
1/16 • From Baseline until 28 days after the last dose of study drug (up to 52 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER