Trial Outcomes & Findings for A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) (NCT NCT02484690)
NCT ID: NCT02484690
Last Updated: 2020-11-12
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 masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
COMPLETED
PHASE2
273 participants
Baseline, Week 36
2020-11-12
Participant Flow
A total of 273 patients were randomized, but 10 participants in total were excluded from the analysis populations, 1, 3, 1, and 5 from Arms B, C, D, and E, respectively, because of Good Clinical Practice (GCP) violations at a single site.
Participant milestones
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
68
|
46
|
39
|
46
|
64
|
|
Overall Study
Received at Least One Dose of Study Drug
|
67
|
46
|
39
|
46
|
64
|
|
Overall Study
COMPLETED
|
64
|
40
|
36
|
44
|
58
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
3
|
2
|
6
|
Reasons for withdrawal
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
0
|
0
|
5
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
76.4 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
78.2 Years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
78.0 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
80.0 Years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
79.2 Years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
78.3 Years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
172 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
91 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
248 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
258 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Best-Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Baseline
|
55.2 BCVA Letters
STANDARD_DEVIATION 12.7 • n=5 Participants
|
56.7 BCVA Letters
STANDARD_DEVIATION 11.1 • n=7 Participants
|
56.2 BCVA Letters
STANDARD_DEVIATION 12.2 • n=5 Participants
|
56.3 BCVA Letters
STANDARD_DEVIATION 11.5 • n=4 Participants
|
55.7 BCVA Letters
STANDARD_DEVIATION 11.6 • n=21 Participants
|
55.9 BCVA Letters
STANDARD_DEVIATION 11.9 • n=8 Participants
|
|
Best-Corrected Visual Acuity (BCVA) Letter Score Category in the Study Eye at Baseline
BCVA Letter Score ≤54
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
104 Participants
n=8 Participants
|
|
Best-Corrected Visual Acuity (BCVA) Letter Score Category in the Study Eye at Baseline
BCVA Letter Score >54
|
45 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
158 Participants
n=8 Participants
|
|
Best-Corrected Visual Acuity (BCVA) Letter Score Category in the Study Eye at Baseline
Assessment Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline
Classic & Occult CNV
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
98 Participants
n=8 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline
Classic CNV
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline
Occult CNV
|
33 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
125 Participants
n=8 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye at Baseline
Assessment Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Presence or Absence of Retinal Angiomatous Proliferation (RAP) in the Study Eye at Baseline
RAP Absent
|
44 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
179 Participants
n=8 Participants
|
|
Presence or Absence of Retinal Angiomatous Proliferation (RAP) in the Study Eye at Baseline
RAP Present
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
|
Presence or Absence of Retinal Angiomatous Proliferation (RAP) in the Study Eye at Baseline
Assessment Missing
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Presence or Absence of Polypoidal Choroidal Vasculopathy (PCV) in the Study Eye at Baseline
PCV Absent
|
61 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
236 Participants
n=8 Participants
|
|
Presence or Absence of Polypoidal Choroidal Vasculopathy (PCV) in the Study Eye at Baseline
PCV Present
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Presence or Absence of Polypoidal Choroidal Vasculopathy (PCV) in the Study Eye at Baseline
Assessment Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants
|
7.61 BCVA Letters
Interval 5.43 to 9.8
|
9.18 BCVA Letters
Interval 6.54 to 11.83
|
6.02 BCVA Letters
Interval 3.24 to 8.8
|
6.10 BCVA Letters
Interval 3.56 to 8.64
|
—
|
PRIMARY outcome
Timeframe: Weeks 12 and 36Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The primary analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=37 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=38 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders
|
1.72 BCVA Letters
Interval -0.69 to 4.13
|
0.04 BCVA Letters
Interval -2.27 to 2.35
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Percentage of Participants Gaining Greater Than or Equal to (≥) 15 Letters From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants
|
31.0 Percentage of Participants
Interval 24.1 to 38.8
|
36.6 Percentage of Participants
Interval 27.6 to 46.7
|
27.9 Percentage of Participants
Interval 19.6 to 38.0
|
23.7 Percentage of Participants
Interval 16.5 to 32.7
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 and 36Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Weeks 12 and 36.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Missing values were not imputed; it was assumed that the data were missing at random.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=35 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=37 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters From Week 12 in BCVA Letter Score at Week 36, in Anti-VEGF Incomplete Responders
|
5.71 Percentage of Participants
Interval 0.69 to 10.74
|
0.00 Percentage of Participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Treatment-Naive Participants
|
49.5 Percentage of Participants
Interval 41.6 to 57.4
|
49.0 Percentage of Participants
Interval 39.2 to 58.8
|
39.4 Percentage of Participants
Interval 29.8 to 49.9
|
41.8 Percentage of Participants
Interval 32.8 to 51.4
|
—
|
SECONDARY outcome
Timeframe: Week 36Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Week 36.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Missing values were not imputed; it was assumed that the data were missing at random.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=35 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=37 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better at Week 36, in Anti-VEGF Incomplete Responders
|
22.86 Percentage of Participants
Interval 13.76 to 31.95
|
16.22 Percentage of Participants
Interval 8.45 to 23.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The outcome measure was analyzed using a Generalized Estimating Equations Model. Missing values were not imputed; it was assumed that the data were missing at random.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Treatment-Naive Participants
|
7.7 Percentage of Participants
Interval 4.4 to 13.2
|
8.7 Percentage of Participants
Interval 4.6 to 16.0
|
15.8 Percentage of Participants
Interval 9.6 to 25.0
|
8.8 Percentage of Participants
Interval 4.7 to 15.9
|
—
|
SECONDARY outcome
Timeframe: Week 36Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Week 36.
Best corrected visual acuity (BCVA) at a starting test distance of 4 meters was measured using a set of three Precision VisionTM or Lighthouse distance acuity charts (modified ETDRS Charts 1, 2, and R) prior to dilating eyes by a trained and certified visual acuity examiner masked to study drug arm assignment. The BCVA examiner was masked to study eye and treatment assignment and only performed the refraction and BCVA assessment, but was not allowed to perform any other tasks involving direct care. The BCVA examiner was also masked to the BCVA letter scores of a participant's previous visits and could only know the participant's refraction data from previous visits. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Missing values were not imputed; it was assumed that the data were missing at random.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=35 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=37 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse at Week 36, in Anti-VEGF Incomplete Responders
|
14.29 Percentage of Participants
Interval 6.71 to 21.87
|
13.51 Percentage of Participants
Interval 6.31 to 20.72
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D.
Foveal center point thickness (FCPT) is defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Foveal Center Point Thickness at Week 36, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT), in Treatment-Naive Participants
|
-194.00 micrometres (μm)
Interval -207.01 to -181.0
|
-181.35 micrometres (μm)
Interval -196.9 to -165.81
|
-193.12 micrometres (μm)
Interval -209.49 to -176.76
|
-161.20 micrometres (μm)
Interval -176.15 to -146.25
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 and 36Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline.
Foveal center point thickness (FCPT) is defined as the thickness from the inner limiting membrane to the retinal pigment epithelial at the horizontal slice closest to the center of the fovea. Foveal center point thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=37 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=38 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Week 12 in Foveal Center Point Thickness at Week 36, as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
|
-14.5 micrometres (μm)
Interval -28.7 to -0.2
|
-20.8 micrometres (μm)
Interval -34.5 to -7.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D.
Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Central Subfield Thickness at Week 36, as Measured by SD-OCT, in Treatment-Naive Participants
|
-176.18 micrometres (μm)
Interval -188.94 to -163.43
|
-156.73 micrometres (μm)
Interval -171.85 to -141.61
|
-173.40 micrometres (μm)
Interval -189.4 to -157.4
|
-147.66 micrometres (μm)
Interval -162.27 to -133.05
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 and 36Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline.
Central subfield thickness (CST) is defined as the mean thickness from the inner limiting membrane to the retinal pigment epithelial over the 1 millimetre (mm) central subfield. Central subfield thickness was measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center. This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=37 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=38 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Week 12 in Central Subfield Thickness at Week 36, as Measured by SD-OCT in Anti-VEGF Incomplete Responders
|
-17.00 micrometres (μm)
Interval -33.12 to -0.88
|
-31.42 micrometres (μm)
Interval -46.83 to -16.02
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D. This analysis only included participants with presence of the individual dry retina measures (cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid) at Baseline and who were reassessed at Week 36.
The presence of cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Cysts were defined as the presence of cystoid space (fluid) in the retina. Intraretinal fluid was defined as the presence of fluid within the retina. Pigment epithelial detachment was defined as the presence of a detachment of the pigment epithelium from the Bruch's membrane. Subretinal fluid was defined as the presence of fluid between the retina and the retinal pigment epithelium. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Cysts: Present at Baseline
|
52 Participants
|
29 Participants
|
29 Participants
|
38 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Cysts: Present at Week 36
|
13 Participants
|
7 Participants
|
6 Participants
|
11 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Cysts: Absent at Week 36
|
36 Participants
|
18 Participants
|
21 Participants
|
25 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Intraretinal Fluid: Present at Baseline
|
67 Participants
|
46 Participants
|
39 Participants
|
45 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Intraretinal Fluid: Present at Week 36
|
46 Participants
|
27 Participants
|
28 Participants
|
34 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Intraretinal Fluid: Absent at Week 36
|
18 Participants
|
13 Participants
|
9 Participants
|
9 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Pigment Epithelial Detachment: Present at Baseline
|
58 Participants
|
37 Participants
|
27 Participants
|
36 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Pigment Epithelial Detachment: Present at Week 36
|
43 Participants
|
25 Participants
|
20 Participants
|
32 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Pigment Epithelial Detachment: Absent at Week 36
|
12 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Subretinal Fluid: Present at Baseline
|
56 Participants
|
41 Participants
|
30 Participants
|
35 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Subretinal Fluid: Present at Week 36
|
11 Participants
|
18 Participants
|
3 Participants
|
8 Participants
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Treatment-Naive Participants
Subretinal Fluid: Absent at Week 36
|
42 Participants
|
18 Participants
|
26 Participants
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 and 36Population: Anti-VEGF incomplete responders, consisting of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with ≥1 letter increase from Baseline. Analysis only included those with presence of individual dry retina measures (cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid) at Week 12 and reassessed at Week 36.
The presence of cysts, intraretinal fluid, pigment epithelial detachment, or subretinal fluid, as per the study's dry retina definition, were evaluated as individual dry retina outcomes. Cysts were defined as the presence of cystoid space (fluid) in the retina. Intraretinal fluid was defined as the presence of fluid within the retina. Pigment epithelial detachment was defined as the presence of a detachment of the pigment epithelium from the Bruch's membrane. Subretinal fluid was defined as the presence of fluid between the retina and the retinal pigment epithelium. All parameters were measured using spectral domain optical coherence tomography (SD-OCT). Anatomic outcome measures were based on results from a central reading center.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=37 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=38 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Cysts: Present at Week 12
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Cysts: Present at Week 36
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Cysts: Absent at Week 36
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Intraretinal Fluid: Present at Week 12
|
28 Participants
|
36 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Intraretinal Fluid: Present at Week 36
|
19 Participants
|
28 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Intraretinal Fluid: Absent at Week 36
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Pigment Epithelial Detachment: Present at Week 12
|
24 Participants
|
28 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Pigment Epithelial Detachment: Present at Week 36
|
19 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Pigment Epithelial Detachment: Absent at Week 36
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Subretinal Fluid: Present at Week 12
|
10 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Subretinal Fluid: Present at Week 36
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Resolution of Dry Retina at Week 36, Defined as Absence of Cysts, Intraretinal Fluid, Pigment Epithelial Detachment, or Subretinal Fluid as Measured by SD-OCT, in Anti-VEGF Incomplete Responders
Subretinal Fluid: Absent at Week 36
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D.
The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA). This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by Fundus Fluorescein Angiography (FFA), in Treatment-Naive Participants
|
-3.41 millimetres squared (mm^2)
Interval -4.34 to -2.49
|
-3.81 millimetres squared (mm^2)
Interval -4.93 to -2.7
|
-3.19 millimetres squared (mm^2)
Interval -4.29 to -2.08
|
-3.31 millimetres squared (mm^2)
Interval -4.31 to -2.3
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 and 36Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Weeks 12 and 36.
The total area of choroidal neovascularization (CNV) was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=22 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=21 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders
|
-0.50 millimetres squared (mm^2)
Standard Deviation 2.37
|
-1.37 millimetres squared (mm^2)
Standard Deviation 3.72
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D.
The total area of choroidal neovascularization (CNV) component (i.e., total area of CNV membrane) was evaluated by a central reading center using fundus fluorescein angiography (FFA). This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Treatment-Naive Participants
|
-4.18 millimetres squared (mm^2)
Interval -5.09 to -3.27
|
-5.14 millimetres squared (mm^2)
Interval -6.24 to -4.04
|
-2.96 millimetres squared (mm^2)
Interval -4.09 to -1.82
|
-3.83 millimetres squared (mm^2)
Interval -4.84 to -2.82
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 and 36Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Weeks 12 and 36.
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 |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=22 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=21 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Week 12 in Total Area of Choroidal Neovascularization (CNV) Component at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders
|
-1.87 millimetres squared (mm^2)
Standard Deviation 4.05
|
-1.88 millimetres squared (mm^2)
Standard Deviation 3.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: Treatment-naive participants randomized to Arms A, B, C, and D.
The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA). This analysis used a Mixed Effects Model for Repeated Measurements (MMRM). Missing data were implicitly imputed by the MMRM, assuming a missing-at-random mechanism.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Total Area of Leakage at Week 36, as Measured by FFA, in Treatment-Naive Participants
|
-5.15 millimetres squared (mm^2)
Interval -6.1 to -4.2
|
-5.94 millimetres squared (mm^2)
Interval -7.1 to -4.77
|
-3.71 millimetres squared (mm^2)
Interval -4.88 to -2.53
|
-4.66 millimetres squared (mm^2)
Interval -5.7 to -3.61
|
—
|
SECONDARY outcome
Timeframe: Weeks 12 and 36Population: Anti-VEGF incomplete responders, which consisted of participants randomized to Arms A and E with BCVA ≤68 at Week 12 with at least one letter improvement relative to Baseline. This analysis only included participants with non-missing assessments at Weeks 12 and 36.
The total area of leakage was evaluated by a central reading center using fundus fluorescein angiography (FFA).
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=22 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=21 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Week 12 in Total Area of Leakage at Week 36, as Measured by FFA, in Anti-VEGF Incomplete Responders
|
-1.87 millimetres squared (mm^2)
Standard Deviation 4.05
|
-2.00 millimetres squared (mm^2)
Standard Deviation 3.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment
This safety summary reports the number and percentage of participants who experienced at least one adverse event (AE) during the study. AEs are categorized as any AEs, ocular AEs occurring in the study eye or fellow eye, systemic AEs, serious AEs, AEs related to treatment with study drug, AEs leading to discontinuation (withdrawal) of treatment with study drug, and AEs with fatal outcome. The investigator independently assessed the seriousness and severity for each AE. Severity was graded according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Severity and seriousness are not synonymous; regardless of severity, some AEs may have also met seriousness criteria.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Any Adverse Event (AE)
|
51 Participants
|
39 Participants
|
31 Participants
|
39 Participants
|
54 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Ocular AE in Either Eye
|
39 Participants
|
25 Participants
|
23 Participants
|
29 Participants
|
37 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Ocular AE in the Study Eye
|
28 Participants
|
21 Participants
|
21 Participants
|
27 Participants
|
28 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Ocular AE in the Fellow Eye
|
21 Participants
|
16 Participants
|
9 Participants
|
18 Participants
|
20 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Serious Ocular AE in the Study Eye
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Ocular AE in Study Eye Leading to Withdrawal
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Systemic AE
|
37 Participants
|
37 Participants
|
23 Participants
|
30 Participants
|
43 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Serious Systemic AE
|
9 Participants
|
7 Participants
|
7 Participants
|
4 Participants
|
6 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Systemic AE Leading to Withdrawal
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
AE with Fatal Outcome
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Any Serious AE
|
9 Participants
|
11 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Any Related Serious AE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Any Related AE
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Related Ocular AE in the Study Eye
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Safety Summary of the Overall Number of Participants With at Least One Adverse Event by Event Type, in All Participants
Related Systemic AE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment
The investigator assessed adverse event severity according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants
Study Eye - Adverse Event (AE) of Any Grade
|
28 Participants
|
21 Participants
|
21 Participants
|
27 Participants
|
28 Participants
|
|
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants
Study Eye - Mild AE
|
27 Participants
|
19 Participants
|
20 Participants
|
25 Participants
|
24 Participants
|
|
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants
Study Eye - Moderate AE
|
4 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants
Study Eye - Severe AE
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants
Fellow Eye - AE of Any Grade
|
21 Participants
|
16 Participants
|
9 Participants
|
18 Participants
|
20 Participants
|
|
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants
Fellow Eye - Mild AE
|
15 Participants
|
14 Participants
|
7 Participants
|
17 Participants
|
17 Participants
|
|
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants
Fellow Eye - Moderate AE
|
5 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye by Highest Intensity, in All Participants
Fellow Eye - Severe AE
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment
The investigator assessed adverse event severity according to the following grading scale: Mild = Discomfort noticed, but no disruption of normal daily activity; Moderate = Discomfort sufficient to reduce or affect normal daily activity; Severe = Incapacitating with inability to work or to perform normal daily activity. Only the most severe intensity was counted for multiple occurrences of the same adverse event per participant at the preferred term level. Severity and seriousness are not synonymous; regardless of severity, some adverse events may have also met seriousness criteria.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants
Any Grade
|
37 Participants
|
37 Participants
|
23 Participants
|
30 Participants
|
43 Participants
|
|
Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants
Mild
|
30 Participants
|
27 Participants
|
17 Participants
|
23 Participants
|
28 Participants
|
|
Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants
Moderate
|
16 Participants
|
18 Participants
|
14 Participants
|
13 Participants
|
26 Participants
|
|
Number of Participants With at Least One Systemic Adverse Event by Highest Intensity, in All Participants
Severe
|
7 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment. In this analysis, the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline.
Abnormal systolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<70 (low) to \>140 (high) millimetres of mercury (mmHg). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Systolic Blood Pressure, in All Participants
Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Systolic Blood Pressure, in All Participants
High
|
20 Participants
|
13 Participants
|
13 Participants
|
23 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment. In this analysis, the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline.
Abnormal diastolic blood pressure (supine) was defined as any value outside of the standard reference range, from \<40 (low) to \>90 (high) millimetres of mercury (mmHg). Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants
Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Diastolic Blood Pressure, in All Participants
High
|
15 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment. In this analysis, the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline.
Abnormal heart rate (supine) was defined as any value outside of the standard reference range, from \<40 (low) to \>100 (high) beats per minute. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Heart Rate, in All Participants
Low
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Heart Rate, in All Participants
High
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed at each study visit from Baseline until 28 days after the last dose of study treatment (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment. In this analysis, the number of participants with an abnormal vital sign (numerator) is reported among the number analyzed (denominator), which represents the number of participants without the abnormal vital sign at baseline.
Abnormal body temperature (supine) was defined as any value outside of the standard reference range, from \<36.5 (low) to \>37.5 (high) degrees Celsius. Baseline was defined as the last non-missing predose assessment. Not every abnormal vital sign qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Body Temperature, in All Participants
High
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Abnormal Body Temperature, in All Participants
Low
|
28 Participants
|
19 Participants
|
14 Participants
|
25 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment. This analysis included participants with non-missing assessments.
Clinical laboratory tests for hematology and coagulation parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. Abs. = absolute count; Corp. = corpuscular; Ery. = erythrocyte; INR = International Normalized Ratio
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Hemoglobin, Low - Last or Replicated
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Lymphocytes, Abs., Low - Any Abnormality
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Basophils, Abs., High - Any Abnormality
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Basophils, Abs., High - Single, Not Last
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Basophils, Abs., High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Eosinophils, Abs., High - Any Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Eosinophils, Abs., High - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Eosinophils, Abs., High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Ery. Mean Corp. Volume, Low - Any Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Ery. Mean Corp. Volume, Low - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Ery. Mean Corp. Volume, Low - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Hematocrit, Low - Any Abnormality
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Hematocrit, Low - Single, Not Last
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Hematocrit, Low - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Hemoglobin, Low - Any Abnormality
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Hemoglobin, Low - Single, Not Last
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Lymphocytes, Abs., Low - Single, Not Last
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Lymphocytes, Abs., Low - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Lymphocytes, Abs., High - Any Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Lymphocytes, Abs., High - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Lymphocytes, Abs., High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Lymphocytes, Pct., Low - Any Abnormality
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Lymphocytes, Pct., Low - Single, Not Last
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Lymphocytes, Pct., Low - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Neutrophils, Total, Abs., Low - Any Abnormality
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Neutrophils, Total, Abs., Low - Single, Not Last
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Neutrophils, Total, Abs., Low - Last or Replicated
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Neutrophils, Total, Abs., High - Any Abnormality
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Neutrophils, Total, Abs., High - Single, Not Last
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Neutrophils, Total, Abs., High -Last or Replicated
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Platelets, Low - Any Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Platelets, Low - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
Platelets, Low - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
White Blood Cell Count, Low - Any Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
White Blood Cell Count, Low - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
White Blood Cell Count, Low - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
White Blood Cell Count, High - Any Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
White Blood Cell Count, High - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
White Blood Cell Count, High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
INR, High - Any Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
INR, High - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Hematology and Coagulation Tests, in All Participants
INR, High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Predose at Baseline, Weeks 12 and 36, and at Early Termination and Unscheduled Visits (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment. This analysis included participants with non-missing assessments.
Clinical laboratory tests for blood chemistry parameters were performed and any marked abnormal values (High or Low) were based on Roche's predefined standard reference ranges. Marked laboratory abnormalities are presented according to COG3007 abnormality criteria: Single, Not Last = abnormality detected at a single assessment, but not at the last assessment; Last or Replicated = abnormality detected at the last assessment or replicated at one or more assessments. Not every laboratory abnormality qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. GGT = gamma-glutamyltransferase; SGOT/AST = serum glutamic oxaloacetic transaminase / aspartate aminotransferase; SGPT/ALT = serum glutamic pyruvic transaminase / alanine aminotransferase
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Alkaline Phosphatase, High - Any Abnormality
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Alkaline Phosphatase, High - Single, Not Last
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Alkaline Phosphatase, High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Bicarbonate (CO2), Low - Any Abnormality
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Bicarbonate (CO2), Low - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Bicarbonate (CO2), Low - Last or Replicated
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Bicarbonate (CO2), High - Any Abnormality
|
5 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Bicarbonate (CO2), High - Single, Not Last
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Bicarbonate (CO2), High - Last or Replicated
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Calcium, Low - Any Abnormality
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Calcium, Low - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Calcium, Low - Last or Replicated
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Calcium, High - Any Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Calcium, High - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Calcium, High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Chloride, Low - Any Abnormality
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Chloride, Low - Single, Not Last
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Chloride, Low - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Creatine Kinase, High - Any Abnormality
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Creatine Kinase, High - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Creatine Kinase, High - Last or Replicated
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Creatinine, High - Any Abnormality
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Creatinine, High - Single, Not Last
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Creatinine, High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
GGT, High - Any Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
GGT, High - Single, Not Last
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
GGT, High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Phosphorus, Low - Any Abnormality
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Phosphorus, Low - Single, Not Last
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Phosphorus, Low - Last or Replicated
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Phosphorus, High - Any Abnormality
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Phosphorus, High - Single, Not Last
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Phosphorus, High - Last or Replicated
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Potassium, High - Any Abnormality
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Potassium, High - Single, Not Last
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Potassium, High - Last or Replicated
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Protein, Total, High - Any Abnormality
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Protein, Total, High - Single, Not Last
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
Protein, Total, High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
SGOT/AST, High - Any Abnormality
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
SGOT/AST, High - Single, Not Last
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
SGOT/AST, High - Last or Replicated
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
SGPT/ALT, High - Any Abnormality
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
SGPT/ALT, High - Single, Not Last
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities in Blood Chemistry Tests, in All Participants
SGPT/ALT, High - Last or Replicated
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 0.5 hours postdose on Day 1, predose and 0.5 hours postdose at Weeks 4, 8, 12, 16, 20, 24, 28, and 32, and at Weeks 1, 13, and 36Population: Safety Population: all participants who received at least one dose of study treatment
Intraocular pressure is the fluid pressure inside the eye. The method used to measure intraocular pressure (e.g., Goldmann tonometry) for each participant was to be applied consistently by the investigator throughout the study. On the day of dosing, intraocular pressure was monitored at 30 minutes post-treatment administration, and if intraocular pressure was ≥30 mmHg in the study eye, it was reassessed at 1 hour post-treatment administration.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 20 (0.5 hr)
|
2.80 millimetres of mercury (mmHg)
Standard Deviation 4.81
|
1.74 millimetres of mercury (mmHg)
Standard Deviation 4.85
|
1.82 millimetres of mercury (mmHg)
Standard Deviation 5.37
|
0.68 millimetres of mercury (mmHg)
Standard Deviation 5.45
|
2.62 millimetres of mercury (mmHg)
Standard Deviation 4.54
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 24 (Predose)
|
0.00 millimetres of mercury (mmHg)
Standard Deviation 3.29
|
-0.33 millimetres of mercury (mmHg)
Standard Deviation 3.30
|
0.26 millimetres of mercury (mmHg)
Standard Deviation 2.77
|
-0.61 millimetres of mercury (mmHg)
Standard Deviation 2.73
|
0.14 millimetres of mercury (mmHg)
Standard Deviation 2.73
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 24 (0.5 hr)
|
3.23 millimetres of mercury (mmHg)
Standard Deviation 3.91
|
3.26 millimetres of mercury (mmHg)
Standard Deviation 4.04
|
4.11 millimetres of mercury (mmHg)
Standard Deviation 3.51
|
0.91 millimetres of mercury (mmHg)
Standard Deviation 3.66
|
4.17 millimetres of mercury (mmHg)
Standard Deviation 4.28
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 28 (Predose)
|
-0.02 millimetres of mercury (mmHg)
Standard Deviation 2.80
|
0.00 millimetres of mercury (mmHg)
Standard Deviation 4.30
|
-1.00 millimetres of mercury (mmHg)
Standard Deviation 2.91
|
-0.38 millimetres of mercury (mmHg)
Standard Deviation 2.74
|
-0.19 millimetres of mercury (mmHg)
Standard Deviation 2.89
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 28 (0.5 hr)
|
3.16 millimetres of mercury (mmHg)
Standard Deviation 4.28
|
2.90 millimetres of mercury (mmHg)
Standard Deviation 4.13
|
1.74 millimetres of mercury (mmHg)
Standard Deviation 4.80
|
2.53 millimetres of mercury (mmHg)
Standard Deviation 3.60
|
3.86 millimetres of mercury (mmHg)
Standard Deviation 4.49
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 32 (Predose)
|
-0.73 millimetres of mercury (mmHg)
Standard Deviation 3.72
|
-0.23 millimetres of mercury (mmHg)
Standard Deviation 3.63
|
-0.41 millimetres of mercury (mmHg)
Standard Deviation 3.07
|
-0.80 millimetres of mercury (mmHg)
Standard Deviation 2.92
|
-0.67 millimetres of mercury (mmHg)
Standard Deviation 3.06
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 32 (0.5 hr)
|
1.81 millimetres of mercury (mmHg)
Standard Deviation 5.10
|
3.87 millimetres of mercury (mmHg)
Standard Deviation 5.58
|
1.63 millimetres of mercury (mmHg)
Standard Deviation 5.47
|
-0.98 millimetres of mercury (mmHg)
Standard Deviation 4.38
|
2.37 millimetres of mercury (mmHg)
Standard Deviation 4.97
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 36
|
0.00 millimetres of mercury (mmHg)
Standard Deviation 3.30
|
0.25 millimetres of mercury (mmHg)
Standard Deviation 3.68
|
-0.65 millimetres of mercury (mmHg)
Standard Deviation 3.85
|
-0.20 millimetres of mercury (mmHg)
Standard Deviation 3.55
|
-0.16 millimetres of mercury (mmHg)
Standard Deviation 3.18
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 13
|
-0.77 millimetres of mercury (mmHg)
Standard Deviation 3.27
|
-0.68 millimetres of mercury (mmHg)
Standard Deviation 3.12
|
-0.71 millimetres of mercury (mmHg)
Standard Deviation 4.02
|
-1.09 millimetres of mercury (mmHg)
Standard Deviation 2.70
|
-0.65 millimetres of mercury (mmHg)
Standard Deviation 2.75
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 16 (Predose)
|
-0.41 millimetres of mercury (mmHg)
Standard Deviation 3.39
|
0.02 millimetres of mercury (mmHg)
Standard Deviation 3.10
|
-0.77 millimetres of mercury (mmHg)
Standard Deviation 3.11
|
-1.00 millimetres of mercury (mmHg)
Standard Deviation 2.56
|
-0.36 millimetres of mercury (mmHg)
Standard Deviation 2.83
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Baseline (BL): Absolute Value
|
15.07 millimetres of mercury (mmHg)
Standard Deviation 3.38
|
14.74 millimetres of mercury (mmHg)
Standard Deviation 3.08
|
14.69 millimetres of mercury (mmHg)
Standard Deviation 3.85
|
14.98 millimetres of mercury (mmHg)
Standard Deviation 2.91
|
14.27 millimetres of mercury (mmHg)
Standard Deviation 2.80
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Day 1 (0.5 hr)
|
1.90 millimetres of mercury (mmHg)
Standard Deviation 4.80
|
2.04 millimetres of mercury (mmHg)
Standard Deviation 5.32
|
1.59 millimetres of mercury (mmHg)
Standard Deviation 4.30
|
2.37 millimetres of mercury (mmHg)
Standard Deviation 4.22
|
3.52 millimetres of mercury (mmHg)
Standard Deviation 4.79
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 1
|
-0.89 millimetres of mercury (mmHg)
Standard Deviation 3.52
|
-0.98 millimetres of mercury (mmHg)
Standard Deviation 3.47
|
-0.62 millimetres of mercury (mmHg)
Standard Deviation 3.35
|
-1.96 millimetres of mercury (mmHg)
Standard Deviation 2.98
|
0.11 millimetres of mercury (mmHg)
Standard Deviation 2.36
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 4 (Predose)
|
-0.27 millimetres of mercury (mmHg)
Standard Deviation 3.16
|
-1.40 millimetres of mercury (mmHg)
Standard Deviation 2.61
|
-1.18 millimetres of mercury (mmHg)
Standard Deviation 3.85
|
-0.87 millimetres of mercury (mmHg)
Standard Deviation 2.99
|
0.59 millimetres of mercury (mmHg)
Standard Deviation 2.49
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 4 (0.5 hr)
|
2.88 millimetres of mercury (mmHg)
Standard Deviation 4.45
|
2.70 millimetres of mercury (mmHg)
Standard Deviation 3.56
|
2.05 millimetres of mercury (mmHg)
Standard Deviation 4.26
|
1.51 millimetres of mercury (mmHg)
Standard Deviation 3.96
|
3.59 millimetres of mercury (mmHg)
Standard Deviation 4.39
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 8 (Predose)
|
-0.56 millimetres of mercury (mmHg)
Standard Deviation 3.85
|
-0.32 millimetres of mercury (mmHg)
Standard Deviation 3.13
|
-0.69 millimetres of mercury (mmHg)
Standard Deviation 3.07
|
-0.87 millimetres of mercury (mmHg)
Standard Deviation 2.75
|
0.10 millimetres of mercury (mmHg)
Standard Deviation 2.64
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 8 (0.5 hr)
|
2.70 millimetres of mercury (mmHg)
Standard Deviation 4.21
|
2.59 millimetres of mercury (mmHg)
Standard Deviation 4.64
|
2.37 millimetres of mercury (mmHg)
Standard Deviation 5.15
|
1.93 millimetres of mercury (mmHg)
Standard Deviation 3.91
|
3.93 millimetres of mercury (mmHg)
Standard Deviation 4.52
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 12 (Predose)
|
-0.17 millimetres of mercury (mmHg)
Standard Deviation 3.49
|
-0.02 millimetres of mercury (mmHg)
Standard Deviation 2.88
|
-0.82 millimetres of mercury (mmHg)
Standard Deviation 3.37
|
0.13 millimetres of mercury (mmHg)
Standard Deviation 2.94
|
0.45 millimetres of mercury (mmHg)
Standard Deviation 2.45
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 12 (0.5 hr)
|
3.08 millimetres of mercury (mmHg)
Standard Deviation 4.01
|
2.43 millimetres of mercury (mmHg)
Standard Deviation 3.41
|
2.59 millimetres of mercury (mmHg)
Standard Deviation 3.95
|
2.11 millimetres of mercury (mmHg)
Standard Deviation 4.04
|
4.34 millimetres of mercury (mmHg)
Standard Deviation 5.25
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 16 (0.5 hr)
|
1.64 millimetres of mercury (mmHg)
Standard Deviation 4.62
|
1.95 millimetres of mercury (mmHg)
Standard Deviation 5.35
|
1.67 millimetres of mercury (mmHg)
Standard Deviation 3.92
|
-0.30 millimetres of mercury (mmHg)
Standard Deviation 3.98
|
3.12 millimetres of mercury (mmHg)
Standard Deviation 5.27
|
|
Mean Change From Baseline in Intraocular Pressure in the Study Eye Over Time, in All Participants
Change from BL at Week 20 (Predose)
|
-0.16 millimetres of mercury (mmHg)
Standard Deviation 3.02
|
-1.00 millimetres of mercury (mmHg)
Standard Deviation 2.73
|
0.08 millimetres of mercury (mmHg)
Standard Deviation 3.61
|
-0.44 millimetres of mercury (mmHg)
Standard Deviation 3.18
|
-0.17 millimetres of mercury (mmHg)
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Baseline, Predose (0 hour) on Days 1, 28, 84, 112, 168, and 252 or early termination (up to 36 weeks)Population: Safety Population: all participants who received at least one dose of study treatment. The analysis only included participants who received treatment with faricimab (i.e., Arm A was excluded) and had evaluable samples at baseline and any post-baseline timepoint.
Blood samples were obtained for measurement of anti-faricimab antibodies by a validated enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=38 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=63 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint
ADA Negative to ADA Positive
|
—
|
3 Participants
|
3 Participants
|
9 Participants
|
6 Participants
|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint
ADA Positive to Missing
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint
ADA Positive to ADA Negative
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint
ADA Positive to ADA Positive
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint
ADA Negative to Missing
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in the Number of Participants With Anti-Drug Antibodies to Faricimab at Any Post-Baseline Timepoint
ADA Negative to ADA Negative
|
—
|
41 Participants
|
35 Participants
|
36 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: Predose (on days when treatment was administered) at Baseline and Weeks 4, 12, 13, 16, 24, and 36Population: Analysis included all randomized participants who had received treatment with faricimab (i.e., excludes Arm A at all timepoints and Arm E at Week 4) and had evaluable pharmacokinetic samples at a given timepoint.
Plasma concentrations of faricimab were measured by a specific validated enzyme-linked immunoabsorbent assay (ELISA) only from samples of participants randomized to receive faricimab. Baseline was defined as the last non-missing predose assessment. The lower limit of quantification (LLOQ) for the faricimab assay was 0.800 nanograms per millilitre (ng/mL). Values below the limit of quantification were imputed as LLOQ divided by 2.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Plasma Concentration of Faricimab Over Time, in All Participants
Baseline
|
—
|
0.40 nanograms per millilitre (ng/mL)
Standard Deviation 0.00
|
0.40 nanograms per millilitre (ng/mL)
Standard Deviation 0.00
|
0.40 nanograms per millilitre (ng/mL)
Standard Deviation 0.00
|
0.47 nanograms per millilitre (ng/mL)
Standard Deviation 0.59
|
|
Mean Plasma Concentration of Faricimab Over Time, in All Participants
Week 4
|
—
|
8.83 nanograms per millilitre (ng/mL)
Standard Deviation 5.85
|
31.06 nanograms per millilitre (ng/mL)
Standard Deviation 18.47
|
36.58 nanograms per millilitre (ng/mL)
Standard Deviation 19.78
|
—
|
|
Mean Plasma Concentration of Faricimab Over Time, in All Participants
Week 12
|
—
|
18.68 nanograms per millilitre (ng/mL)
Standard Deviation 24.38
|
57.92 nanograms per millilitre (ng/mL)
Standard Deviation 57.65
|
57.94 nanograms per millilitre (ng/mL)
Standard Deviation 73.91
|
45.29 nanograms per millilitre (ng/mL)
Standard Deviation 105.64
|
|
Mean Plasma Concentration of Faricimab Over Time, in All Participants
Week 13
|
—
|
43.32 nanograms per millilitre (ng/mL)
Standard Deviation 31.98
|
184.38 nanograms per millilitre (ng/mL)
Standard Deviation 102.01
|
178.25 nanograms per millilitre (ng/mL)
Standard Deviation 119.98
|
160.52 nanograms per millilitre (ng/mL)
Standard Deviation 124.73
|
|
Mean Plasma Concentration of Faricimab Over Time, in All Participants
Week 16
|
—
|
9.52 nanograms per millilitre (ng/mL)
Standard Deviation 7.41
|
46.99 nanograms per millilitre (ng/mL)
Standard Deviation 35.19
|
43.54 nanograms per millilitre (ng/mL)
Standard Deviation 39.05
|
44.71 nanograms per millilitre (ng/mL)
Standard Deviation 50.55
|
|
Mean Plasma Concentration of Faricimab Over Time, in All Participants
Week 24
|
—
|
9.07 nanograms per millilitre (ng/mL)
Standard Deviation 7.39
|
35.30 nanograms per millilitre (ng/mL)
Standard Deviation 22.03
|
31.19 nanograms per millilitre (ng/mL)
Standard Deviation 24.13
|
37.80 nanograms per millilitre (ng/mL)
Standard Deviation 27.75
|
|
Mean Plasma Concentration of Faricimab Over Time, in All Participants
Week 36
|
—
|
10.65 nanograms per millilitre (ng/mL)
Standard Deviation 8.47
|
36.43 nanograms per millilitre (ng/mL)
Standard Deviation 30.80
|
4.69 nanograms per millilitre (ng/mL)
Standard Deviation 7.24
|
36.06 nanograms per millilitre (ng/mL)
Standard Deviation 26.93
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 13, 16, 24, and 36Population: Analysis included all randomized participants who had received study treatment and had evaluable pharmacodynamic samples at a given timepoint.
The concentration of free VEGF was determined in plasma samples using an enzyme-linked immunosorbent assay (ELISA) method. The lower limit of quantification (LLOQ) of the assay was 15.6 picograms per millilitre (pg/mL). Plasma free VEGF concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants
Baseline (BL) - Value at Visit
|
15.25 picograms per millilitre (pg/mL)
Standard Deviation 10.60
|
16.83 picograms per millilitre (pg/mL)
Standard Deviation 12.08
|
24.63 picograms per millilitre (pg/mL)
Standard Deviation 31.47
|
16.53 picograms per millilitre (pg/mL)
Standard Deviation 9.73
|
22.60 picograms per millilitre (pg/mL)
Standard Deviation 27.79
|
|
Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 4
|
0.52 picograms per millilitre (pg/mL)
Standard Deviation 12.20
|
3.94 picograms per millilitre (pg/mL)
Standard Deviation 33.25
|
-9.26 picograms per millilitre (pg/mL)
Standard Deviation 27.76
|
-0.62 picograms per millilitre (pg/mL)
Standard Deviation 15.67
|
3.75 picograms per millilitre (pg/mL)
Standard Deviation 53.99
|
|
Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 12
|
1.52 picograms per millilitre (pg/mL)
Standard Deviation 19.45
|
-0.46 picograms per millilitre (pg/mL)
Standard Deviation 13.30
|
-8.58 picograms per millilitre (pg/mL)
Standard Deviation 20.73
|
-4.70 picograms per millilitre (pg/mL)
Standard Deviation 11.79
|
-3.24 picograms per millilitre (pg/mL)
Standard Deviation 27.79
|
|
Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 13
|
2.62 picograms per millilitre (pg/mL)
Standard Deviation 21.69
|
5.47 picograms per millilitre (pg/mL)
Standard Deviation 52.19
|
-14.10 picograms per millilitre (pg/mL)
Standard Deviation 33.55
|
-7.36 picograms per millilitre (pg/mL)
Standard Deviation 10.67
|
-15.14 picograms per millilitre (pg/mL)
Standard Deviation 33.85
|
|
Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 16
|
12.12 picograms per millilitre (pg/mL)
Standard Deviation 67.43
|
-3.28 picograms per millilitre (pg/mL)
Standard Deviation 10.61
|
-9.86 picograms per millilitre (pg/mL)
Standard Deviation 33.05
|
-6.28 picograms per millilitre (pg/mL)
Standard Deviation 10.84
|
-5.34 picograms per millilitre (pg/mL)
Standard Deviation 32.90
|
|
Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 24
|
-0.67 picograms per millilitre (pg/mL)
Standard Deviation 10.45
|
10.35 picograms per millilitre (pg/mL)
Standard Deviation 50.09
|
-12.57 picograms per millilitre (pg/mL)
Standard Deviation 31.86
|
-5.20 picograms per millilitre (pg/mL)
Standard Deviation 10.07
|
-7.19 picograms per millilitre (pg/mL)
Standard Deviation 31.54
|
|
Mean Change From Baseline in Free Vascular Endothelial Growth Factor-A (VEGF-A) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 36
|
1.91 picograms per millilitre (pg/mL)
Standard Deviation 28.59
|
-0.79 picograms per millilitre (pg/mL)
Standard Deviation 11.86
|
-12.16 picograms per millilitre (pg/mL)
Standard Deviation 32.48
|
-1.34 picograms per millilitre (pg/mL)
Standard Deviation 13.69
|
-8.17 picograms per millilitre (pg/mL)
Standard Deviation 29.73
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 13, 16, 24, and 36Population: Analysis included all randomized participants who had received study treatment and had evaluable pharmacodynamic samples at a given timepoint.
Total Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.09 nanograms per millilitre (ng/mL). Plasma total Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Baseline (BL) - Value at Visit
|
2.14 nanograms per millilitre (ng/mL)
Standard Deviation 1.38
|
1.81 nanograms per millilitre (ng/mL)
Standard Deviation 0.67
|
1.86 nanograms per millilitre (ng/mL)
Standard Deviation 1.12
|
1.80 nanograms per millilitre (ng/mL)
Standard Deviation 0.71
|
1.92 nanograms per millilitre (ng/mL)
Standard Deviation 0.95
|
|
Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 4
|
0.03 nanograms per millilitre (ng/mL)
Standard Deviation 0.48
|
0.09 nanograms per millilitre (ng/mL)
Standard Deviation 0.39
|
0.09 nanograms per millilitre (ng/mL)
Standard Deviation 0.27
|
0.20 nanograms per millilitre (ng/mL)
Standard Deviation 0.49
|
-0.03 nanograms per millilitre (ng/mL)
Standard Deviation 0.38
|
|
Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 12
|
0.10 nanograms per millilitre (ng/mL)
Standard Deviation 0.89
|
0.14 nanograms per millilitre (ng/mL)
Standard Deviation 0.37
|
0.22 nanograms per millilitre (ng/mL)
Standard Deviation 0.48
|
0.19 nanograms per millilitre (ng/mL)
Standard Deviation 0.50
|
-0.11 nanograms per millilitre (ng/mL)
Standard Deviation 0.49
|
|
Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 13
|
0.18 nanograms per millilitre (ng/mL)
Standard Deviation 0.91
|
0.23 nanograms per millilitre (ng/mL)
Standard Deviation 0.35
|
1.05 nanograms per millilitre (ng/mL)
Standard Deviation 1.15
|
0.87 nanograms per millilitre (ng/mL)
Standard Deviation 0.76
|
0.81 nanograms per millilitre (ng/mL)
Standard Deviation 0.98
|
|
Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 16
|
0.01 nanograms per millilitre (ng/mL)
Standard Deviation 0.62
|
0.04 nanograms per millilitre (ng/mL)
Standard Deviation 0.71
|
0.24 nanograms per millilitre (ng/mL)
Standard Deviation 0.47
|
0.22 nanograms per millilitre (ng/mL)
Standard Deviation 0.61
|
-0.01 nanograms per millilitre (ng/mL)
Standard Deviation 0.52
|
|
Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 24
|
0.00 nanograms per millilitre (ng/mL)
Standard Deviation 0.68
|
0.11 nanograms per millilitre (ng/mL)
Standard Deviation 0.77
|
0.21 nanograms per millilitre (ng/mL)
Standard Deviation 0.52
|
0.24 nanograms per millilitre (ng/mL)
Standard Deviation 0.57
|
0.04 nanograms per millilitre (ng/mL)
Standard Deviation 0.44
|
|
Mean Change From Baseline in Total Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 36
|
0.08 nanograms per millilitre (ng/mL)
Standard Deviation 0.42
|
0.05 nanograms per millilitre (ng/mL)
Standard Deviation 0.42
|
0.25 nanograms per millilitre (ng/mL)
Standard Deviation 0.39
|
0.33 nanograms per millilitre (ng/mL)
Standard Deviation 0.89
|
0.05 nanograms per millilitre (ng/mL)
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 13, 16, 24, and 36Population: Analysis included all randomized participants who had received study treatment and had evaluable pharmacodynamic samples at a given timepoint.
Free Ang-2 concentrations were determined in plasma samples using an appropriate assay method. The lower limit of quantification (LLOQ) of the assay was 0.9 nanograms per millilitre (ng/mL). Plasma free Ang-2 concentrations below the limit of quantification were imputed as LLOQ divided by 2.
Outcome measures
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=68 Participants
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 Participants
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 Participants
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 Participants
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 Participants
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Baseline (BL) - Value at Visit
|
2.19 nanograms per millilitre (ng/mL)
Standard Deviation 1.38
|
1.81 nanograms per millilitre (ng/mL)
Standard Deviation 0.73
|
1.88 nanograms per millilitre (ng/mL)
Standard Deviation 0.98
|
1.73 nanograms per millilitre (ng/mL)
Standard Deviation 0.75
|
1.95 nanograms per millilitre (ng/mL)
Standard Deviation 1.12
|
|
Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 4
|
0.00 nanograms per millilitre (ng/mL)
Standard Deviation 0.57
|
0.14 nanograms per millilitre (ng/mL)
Standard Deviation 0.37
|
-0.05 nanograms per millilitre (ng/mL)
Standard Deviation 0.46
|
0.15 nanograms per millilitre (ng/mL)
Standard Deviation 0.62
|
-0.07 nanograms per millilitre (ng/mL)
Standard Deviation 0.55
|
|
Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 12
|
0.23 nanograms per millilitre (ng/mL)
Standard Deviation 1.12
|
0.20 nanograms per millilitre (ng/mL)
Standard Deviation 0.57
|
0.12 nanograms per millilitre (ng/mL)
Standard Deviation 0.52
|
0.21 nanograms per millilitre (ng/mL)
Standard Deviation 0.75
|
-0.01 nanograms per millilitre (ng/mL)
Standard Deviation 0.59
|
|
Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 13
|
0.03 nanograms per millilitre (ng/mL)
Standard Deviation 0.92
|
0.23 nanograms per millilitre (ng/mL)
Standard Deviation 0.69
|
0.81 nanograms per millilitre (ng/mL)
Standard Deviation 1.11
|
0.55 nanograms per millilitre (ng/mL)
Standard Deviation 0.75
|
0.32 nanograms per millilitre (ng/mL)
Standard Deviation 0.93
|
|
Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 16
|
0.06 nanograms per millilitre (ng/mL)
Standard Deviation 0.77
|
0.17 nanograms per millilitre (ng/mL)
Standard Deviation 0.95
|
0.15 nanograms per millilitre (ng/mL)
Standard Deviation 0.62
|
0.22 nanograms per millilitre (ng/mL)
Standard Deviation 0.67
|
-0.11 nanograms per millilitre (ng/mL)
Standard Deviation 0.65
|
|
Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 24
|
0.18 nanograms per millilitre (ng/mL)
Standard Deviation 0.90
|
0.20 nanograms per millilitre (ng/mL)
Standard Deviation 0.93
|
0.25 nanograms per millilitre (ng/mL)
Standard Deviation 0.49
|
0.39 nanograms per millilitre (ng/mL)
Standard Deviation 0.58
|
0.13 nanograms per millilitre (ng/mL)
Standard Deviation 0.59
|
|
Mean Change From Baseline in Free Angiopoietin-2 (Ang-2) Plasma Concentrations Over Time, in All Participants
Change from BL at Week 36
|
0.16 nanograms per millilitre (ng/mL)
Standard Deviation 0.74
|
0.25 nanograms per millilitre (ng/mL)
Standard Deviation 0.65
|
0.28 nanograms per millilitre (ng/mL)
Standard Deviation 0.63
|
0.51 nanograms per millilitre (ng/mL)
Standard Deviation 1.30
|
0.06 nanograms per millilitre (ng/mL)
Standard Deviation 0.66
|
Adverse Events
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
Arm B: Faricimab, 1.5 mg Q4W
Arm C: Faricimab, 6 mg Q4W
Arm D: Faricimab, 6 mg Every 4-8 Weeks
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Serious adverse events
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 participants at risk
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 participants at risk
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 participants at risk
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 participants at risk
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 participants at risk
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Cardiac disorders
Cardiac disorder
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Cardiac disorders
Degenerative mitral valve disease
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Cardiac disorders
Pericardial effusion
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Glaucoma
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Keratic Precipitates
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Macular hole
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Neovascular age-related macular degeneration
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
General disorders
Chest pain
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Cystitis
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Investigations
Arteriogram coronary
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Investigations
Blood potassium increased
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spindle cell sarcoma
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Surgical and medical procedures
Pulmonary resection
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Vascular disorders
Hypertension
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Vascular disorders
Shock
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
Other adverse events
| Measure |
Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
n=67 participants at risk
Participants received ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) once every 4 weeks (Q4W) up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm B: Faricimab, 1.5 mg Q4W
n=46 participants at risk
Participants received faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit took place at Week 36.
|
Arm C: Faricimab, 6 mg Q4W
n=39 participants at risk
Participants received faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit took place at Week 36.
|
Arm D: Faricimab, 6 mg Every 4-8 Weeks
n=46 participants at risk
Participants received faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit took place at Week 36.
|
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
n=64 participants at risk
Participants received ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit took place at Week 36.
|
|---|---|---|---|---|---|
|
Eye disorders
Anterior chamber cell
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Blepharitis
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Cataract
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Conjunctival haemorrhage
|
20.9%
14/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
8.7%
4/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
15.4%
6/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
13.0%
6/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
9.4%
6/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Dry age-related macular degeneration
|
6.0%
4/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Eye irritation
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
10.3%
4/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
8.7%
4/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Eye pain
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
8.7%
4/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
10.9%
5/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.7%
3/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Lacrimation increased
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.5%
3/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Neovascular age-related macular degeneration
|
9.0%
6/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
8.7%
4/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
7.7%
3/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
7.8%
5/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Posterior capsule opacification
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
7.7%
3/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
7.8%
5/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Retinal pigment epithelial tear
|
4.5%
3/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Vision blurred
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
7.7%
3/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Vitreous detachment
|
4.5%
3/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
10.9%
5/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
7.7%
3/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
10.9%
5/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.2%
4/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Vitreous floaters
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.5%
3/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
10.3%
4/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.5%
3/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Influenza
|
4.5%
3/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.5%
3/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Nasopharyngitis
|
13.4%
9/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
8.7%
4/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
7.8%
5/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.5%
3/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Urinary tract infection
|
9.0%
6/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
23.9%
11/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.7%
3/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.5%
3/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.7%
3/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.5%
3/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Investigations
Weight decreased
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Investigations
Weight increased
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Psychiatric disorders
Anxiety
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.2%
4/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
5.1%
2/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Vascular disorders
Hypertension
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
6.5%
3/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.7%
3/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Anterior chamber flare
|
4.5%
3/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Dry eye
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Eye disorders
Visual acuity reduced
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
General disorders
Pyrexia
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
General disorders
Sensation of foreign body
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Cystitis
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.7%
3/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Gastroenteritis viral
|
4.5%
3/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Sinusitis
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Tooth abscess
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.7%
3/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.6%
1/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
1.6%
1/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Nervous system disorders
Dizziness
|
1.5%
1/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Nervous system disorders
Headache
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Nervous system disorders
Migraine
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Psychiatric disorders
Depression
|
0.00%
0/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
3.0%
2/67 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
2.2%
1/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
0.00%
0/39 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
4.3%
2/46 • From Baseline until 28 days after the last dose of study treatment (up to 36 weeks)
|
3.1%
2/64 • From Baseline until 28 days after the last dose of study treatment (up to 36 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