Trial Outcomes & Findings for Efficacy and Safety of RTH258 Versus Aflibercept - Study 1 (NCT NCT02307682)
NCT ID: NCT02307682
Last Updated: 2025-01-16
Results Overview
BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1775 participants
Primary outcome timeframe
Baseline, Week 48
Results posted on
2025-01-16
Participant Flow
Subjects were recruited from investigative sites located in Argentina, Australia, Canada, Colombia, Israel, Japan, Mexico, New Zealand, Panama, Puerto Rico, and USA.
Of the 1775 subjects enrolled in the study, 693 were exited prior to randomization as screen failures. This reporting group includes all randomized subjects.
Participant milestones
| Measure |
Brolucizumab 3 mg
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Overall Study
STARTED
|
360
|
361
|
361
|
|
Overall Study
Randomized and Treated
|
358
|
360
|
360
|
|
Overall Study
COMPLETED
|
310
|
304
|
297
|
|
Overall Study
NOT COMPLETED
|
50
|
57
|
64
|
Reasons for withdrawal
| Measure |
Brolucizumab 3 mg
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
8
|
12
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
8
|
|
Overall Study
Progressive Disease
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
26
|
34
|
23
|
|
Overall Study
Death
|
9
|
7
|
12
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
6
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
2
|
|
Overall Study
Other
|
1
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of RTH258 Versus Aflibercept - Study 1
Baseline characteristics by cohort
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
Total
n=1078 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
76.7 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
76.7 years
STANDARD_DEVIATION 8.95 • n=7 Participants
|
76.2 years
STANDARD_DEVIATION 8.80 • n=5 Participants
|
76.5 years
STANDARD_DEVIATION 8.68 • n=4 Participants
|
|
Age, Customized
Less than 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
50-64 years
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
103 Participants
n=4 Participants
|
|
Age, Customized
65-74 years
|
103 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Age, Customized
75-84 years
|
162 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
465 Participants
n=4 Participants
|
|
Age, Customized
85 years and greater
|
62 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
210 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
609 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
469 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
323 Participants
n=5 Participants
|
329 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
971 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
158 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
302 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
874 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Best Corrected Visual Acuity (BCVA) (letters read)
|
61.0 letters
STANDARD_DEVIATION 13.57 • n=5 Participants
|
60.8 letters
STANDARD_DEVIATION 13.66 • n=7 Participants
|
60.0 letters
STANDARD_DEVIATION 13.92 • n=5 Participants
|
60.6 letters
STANDARD_DEVIATION 13.71 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48Population: Full Analysis Set (FAS) - Last Observation Carried Forward (LOCF)
BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye
|
5.9 letters
Standard Deviation 13.49
|
6.4 letters
Standard Deviation 14.40
|
7.0 letters
Standard Deviation 13.16
|
SECONDARY outcome
Timeframe: Baseline, Weeks 36, 40, 44, 48Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye
|
6.0 letters
Standard Deviation 13.37
|
6.5 letters
Standard Deviation 13.85
|
6.9 letters
Standard Deviation 12.61
|
SECONDARY outcome
Timeframe: Weeks 16, 20, 28, 32, 40, 44, 48Population: FAS - efficacy/safety approach
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for brolucizumab 3mg and 6 mg arms only.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48
|
0.4939 proportion of subjects
Interval 0.4393 to 0.5461
|
0.5563 proportion of subjects
Interval 0.5016 to 0.6075
|
—
|
SECONDARY outcome
Timeframe: Weeks 16, 20, 28, 32, 40, 44, 48Population: FAS - efficacy/safety approach
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=208 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=222 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the First q12 Cycle (Week 16, Week 20)
|
0.8085 proportion of subjects
Interval 0.7454 to 0.8574
|
0.8539 proportion of subjects
Interval 0.7987 to 0.895
|
—
|
SECONDARY outcome
Timeframe: Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96Population: FAS - efficacy/safety approach
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Proportion of Subjects With Positive q12 Treatment Status up to Week 96
|
0.3973 proportion of subjects
Interval 0.3427 to 0.4514
|
0.4537 proportion of subjects
Interval 0.3984 to 0.5072
|
—
|
SECONDARY outcome
Timeframe: Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96Population: FAS - efficacy/safety approach
Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks "q12w", after the initial three loading injections every 4 weeks "q4w"). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=208 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=222 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12 Cycle (Week 16, Week 20)
|
0.6504 proportion of subjects
Interval 0.5749 to 0.7159
|
0.6963 proportion of subjects
Interval 0.627 to 0.7554
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 4
|
3.7 letters
Standard Deviation 8.36
|
3.8 letters
Standard Deviation 9.77
|
4.2 letters
Standard Deviation 7.93
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 8
|
5.7 letters
Standard Deviation 8.83
|
5.5 letters
Standard Deviation 10.71
|
6.1 letters
Standard Deviation 9.48
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 12
|
5.7 letters
Standard Deviation 10.19
|
6.0 letters
Standard Deviation 11.71
|
6.3 letters
Standard Deviation 10.41
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 16
|
5.7 letters
Standard Deviation 11.44
|
6.3 letters
Standard Deviation 11.65
|
6.1 letters
Standard Deviation 10.89
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 20
|
6.2 letters
Standard Deviation 11.40
|
6.2 letters
Standard Deviation 12.30
|
7.1 letters
Standard Deviation 11.25
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 24
|
6.1 letters
Standard Deviation 11.95
|
6.4 letters
Standard Deviation 12.50
|
6.8 letters
Standard Deviation 11.72
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 28
|
6.2 letters
Standard Deviation 12.67
|
6.7 letters
Standard Deviation 13.23
|
6.7 letters
Standard Deviation 12.30
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 32
|
5.6 letters
Standard Deviation 13.42
|
6.8 letters
Standard Deviation 13.41
|
6.6 letters
Standard Deviation 12.43
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 36
|
5.6 letters
Standard Deviation 13.45
|
6.5 letters
Standard Deviation 13.74
|
7.1 letters
Standard Deviation 12.46
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 40
|
6.2 letters
Standard Deviation 13.96
|
6.6 letters
Standard Deviation 14.55
|
6.9 letters
Standard Deviation 12.96
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 44
|
6.2 letters
Standard Deviation 14.05
|
6.6 letters
Standard Deviation 14.01
|
6.7 letters
Standard Deviation 13.37
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 48
|
5.9 letters
Standard Deviation 13.49
|
6.4 letters
Standard Deviation 14.40
|
7.0 letters
Standard Deviation 13.16
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 52
|
6.2 letters
Standard Deviation 14.00
|
6.2 letters
Standard Deviation 14.58
|
6.8 letters
Standard Deviation 14.10
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 56
|
6.2 letters
Standard Deviation 14.08
|
6.1 letters
Standard Deviation 14.88
|
7.1 letters
Standard Deviation 13.31
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 60
|
6.2 letters
Standard Deviation 14.26
|
6.2 letters
Standard Deviation 14.72
|
6.7 letters
Standard Deviation 13.96
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 64
|
5.9 letters
Standard Deviation 14.67
|
6.0 letters
Standard Deviation 15.16
|
6.6 letters
Standard Deviation 13.75
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 68
|
6.0 letters
Standard Deviation 14.60
|
5.9 letters
Standard Deviation 15.10
|
6.5 letters
Standard Deviation 13.95
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 72
|
6.0 letters
Standard Deviation 14.95
|
5.6 letters
Standard Deviation 14.80
|
6.2 letters
Standard Deviation 14.50
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 76
|
6.2 letters
Standard Deviation 14.91
|
5.9 letters
Standard Deviation 15.09
|
6.3 letters
Standard Deviation 14.21
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 80
|
6.1 letters
Standard Deviation 14.83
|
6.1 letters
Standard Deviation 15.33
|
5.8 letters
Standard Deviation 14.42
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 84
|
5.8 letters
Standard Deviation 15.01
|
5.5 letters
Standard Deviation 14.94
|
5.6 letters
Standard Deviation 14.36
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 88
|
5.8 letters
Standard Deviation 15.43
|
5.7 letters
Standard Deviation 15.45
|
5.8 letters
Standard Deviation 14.67
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 92
|
5.8 letters
Standard Deviation 15.48
|
5.8 letters
Standard Deviation 15.21
|
5.9 letters
Standard Deviation 14.64
|
|
Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 96
|
5.4 letters
Standard Deviation 15.86
|
5.6 letters
Standard Deviation 15.62
|
5.6 letters
Standard Deviation 14.78
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye
Change from baseline over the period Week 4 to 48
|
5.7 letters
Standard Deviation 10.43
|
6.2 letters
Standard Deviation 11.62
|
6.5 letters
Standard Deviation 10.49
|
|
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye
Change from baseline over the period Week 4 to 96
|
5.8 letters
Standard Deviation 12.06
|
6.0 letters
Standard Deviation 12.73
|
6.4 letters
Standard Deviation 11.76
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye
Change from baseline over the period Week 12 to 48
|
5.9 letters
Standard Deviation 11.45
|
6.5 letters
Standard Deviation 12.28
|
6.7 letters
Standard Deviation 11.27
|
|
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye
Change from baseline over the period Week 12 to 96
|
5.9 letters
Standard Deviation 12.76
|
6.1 letters
Standard Deviation 13.21
|
6.5 letters
Standard Deviation 12.28
|
SECONDARY outcome
Timeframe: Baseline, Weeks 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye
|
5.7 letters
Standard Deviation 15.15
|
5.7 letters
Standard Deviation 15.05
|
5.7 letters
Standard Deviation 14.29
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 4
|
9.2 percentage of subjects
Interval 6.4 to 12.7
|
10.8 percentage of subjects
Interval 7.8 to 14.5
|
9.7 percentage of subjects
Interval 6.9 to 13.3
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 8
|
15.9 percentage of subjects
Interval 12.3 to 20.1
|
19.2 percentage of subjects
Interval 15.2 to 23.6
|
15.6 percentage of subjects
Interval 12.0 to 19.7
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 12
|
20.1 percentage of subjects
Interval 16.1 to 24.6
|
24.4 percentage of subjects
Interval 20.1 to 29.2
|
20.3 percentage of subjects
Interval 16.2 to 24.8
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 16
|
22.6 percentage of subjects
Interval 18.4 to 27.3
|
22.5 percentage of subjects
Interval 18.3 to 27.2
|
20.8 percentage of subjects
Interval 16.8 to 25.4
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 20
|
22.6 percentage of subjects
Interval 18.4 to 27.3
|
25.8 percentage of subjects
Interval 21.4 to 30.7
|
22.8 percentage of subjects
Interval 18.5 to 27.5
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 24
|
23.2 percentage of subjects
Interval 18.9 to 27.9
|
28.3 percentage of subjects
Interval 23.7 to 33.3
|
21.9 percentage of subjects
Interval 17.8 to 26.6
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 28
|
27.4 percentage of subjects
Interval 22.8 to 32.3
|
28.1 percentage of subjects
Interval 23.5 to 33.0
|
25.8 percentage of subjects
Interval 21.4 to 30.7
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 32
|
25.4 percentage of subjects
Interval 21.0 to 30.3
|
31.9 percentage of subjects
Interval 27.2 to 37.0
|
25.0 percentage of subjects
Interval 20.6 to 29.8
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 36
|
24.9 percentage of subjects
Interval 20.5 to 29.7
|
31.7 percentage of subjects
Interval 26.9 to 36.7
|
24.7 percentage of subjects
Interval 20.4 to 29.5
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 40
|
27.1 percentage of subjects
Interval 22.6 to 32.0
|
33.6 percentage of subjects
Interval 28.7 to 38.7
|
26.4 percentage of subjects
Interval 21.9 to 31.3
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 44
|
27.7 percentage of subjects
Interval 23.1 to 32.6
|
34.2 percentage of subjects
Interval 29.3 to 39.3
|
27.5 percentage of subjects
Interval 23.0 to 32.4
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 48
|
24.9 percentage of subjects
Interval 20.5 to 29.7
|
33.1 percentage of subjects
Interval 28.2 to 38.2
|
25.8 percentage of subjects
Interval 21.4 to 30.7
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 52
|
29.9 percentage of subjects
Interval 25.2 to 34.9
|
31.7 percentage of subjects
Interval 26.9 to 36.7
|
28.1 percentage of subjects
Interval 23.5 to 33.0
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 56
|
29.9 percentage of subjects
Interval 25.2 to 34.9
|
31.7 percentage of subjects
Interval 26.9 to 36.7
|
29.7 percentage of subjects
Interval 25.0 to 34.7
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 60
|
27.7 percentage of subjects
Interval 23.1 to 32.6
|
32.5 percentage of subjects
Interval 27.7 to 37.6
|
28.6 percentage of subjects
Interval 24.0 to 33.6
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 64
|
30.7 percentage of subjects
Interval 26.0 to 35.8
|
32.5 percentage of subjects
Interval 27.7 to 37.6
|
27.8 percentage of subjects
Interval 23.2 to 32.7
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 68
|
29.9 percentage of subjects
Interval 25.2 to 34.9
|
32.5 percentage of subjects
Interval 27.7 to 37.6
|
28.1 percentage of subjects
Interval 23.5 to 33.0
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 72
|
30.4 percentage of subjects
Interval 25.7 to 35.5
|
31.4 percentage of subjects
Interval 26.6 to 36.5
|
27.5 percentage of subjects
Interval 23.0 to 32.4
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 76
|
33.8 percentage of subjects
Interval 28.9 to 39.0
|
32.5 percentage of subjects
Interval 27.7 to 37.6
|
28.6 percentage of subjects
Interval 24.0 to 33.6
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 80
|
28.5 percentage of subjects
Interval 23.9 to 33.5
|
35.6 percentage of subjects
Interval 30.6 to 40.7
|
27.8 percentage of subjects
Interval 23.2 to 32.7
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 84
|
29.3 percentage of subjects
Interval 24.7 to 34.3
|
30.0 percentage of subjects
Interval 25.3 to 35.0
|
26.7 percentage of subjects
Interval 22.2 to 31.6
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 88
|
31.0 percentage of subjects
Interval 26.2 to 36.1
|
34.7 percentage of subjects
Interval 29.8 to 39.9
|
27.8 percentage of subjects
Interval 23.2 to 32.7
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 92
|
28.8 percentage of subjects
Interval 24.1 to 33.8
|
32.8 percentage of subjects
Interval 27.9 to 37.9
|
28.1 percentage of subjects
Interval 23.5 to 33.0
|
|
Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 96
|
32.1 percentage of subjects
Interval 27.3 to 37.2
|
33.6 percentage of subjects
Interval 28.7 to 38.7
|
27.5 percentage of subjects
Interval 23.0 to 32.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 4
|
19.3 percentage of subjects
Interval 15.3 to 23.7
|
24.4 percentage of subjects
Interval 20.1 to 29.2
|
19.2 percentage of subjects
Interval 15.2 to 23.6
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 8
|
30.7 percentage of subjects
Interval 26.0 to 35.8
|
32.5 percentage of subjects
Interval 27.7 to 37.6
|
32.2 percentage of subjects
Interval 27.4 to 37.3
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 12
|
33.2 percentage of subjects
Interval 28.4 to 38.4
|
38.6 percentage of subjects
Interval 33.6 to 43.9
|
33.9 percentage of subjects
Interval 29.0 to 39.0
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 16
|
35.2 percentage of subjects
Interval 30.2 to 40.4
|
39.7 percentage of subjects
Interval 34.6 to 45.0
|
35.6 percentage of subjects
Interval 30.6 to 40.7
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 20
|
37.2 percentage of subjects
Interval 32.1 to 42.4
|
42.2 percentage of subjects
Interval 37.1 to 47.5
|
38.3 percentage of subjects
Interval 33.3 to 43.6
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 24
|
40.2 percentage of subjects
Interval 35.1 to 45.5
|
41.9 percentage of subjects
Interval 36.8 to 47.2
|
39.4 percentage of subjects
Interval 34.4 to 44.7
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 28
|
41.1 percentage of subjects
Interval 35.9 to 46.4
|
43.9 percentage of subjects
Interval 38.7 to 49.2
|
41.4 percentage of subjects
Interval 36.3 to 46.7
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 32
|
38.3 percentage of subjects
Interval 33.2 to 43.5
|
43.9 percentage of subjects
Interval 38.7 to 49.2
|
41.7 percentage of subjects
Interval 36.5 to 46.9
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 36
|
41.1 percentage of subjects
Interval 35.9 to 46.4
|
43.3 percentage of subjects
Interval 38.1 to 48.6
|
43.1 percentage of subjects
Interval 37.9 to 48.3
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 40
|
41.3 percentage of subjects
Interval 36.2 to 46.6
|
45.3 percentage of subjects
Interval 40.1 to 50.6
|
44.2 percentage of subjects
Interval 39.0 to 49.5
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 44
|
44.4 percentage of subjects
Interval 39.2 to 49.7
|
43.1 percentage of subjects
Interval 37.9 to 48.3
|
44.2 percentage of subjects
Interval 39.0 to 49.5
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 48
|
41.3 percentage of subjects
Interval 36.2 to 46.6
|
45.3 percentage of subjects
Interval 40.1 to 50.6
|
44.2 percentage of subjects
Interval 39.0 to 49.5
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 52
|
43.0 percentage of subjects
Interval 37.8 to 48.3
|
43.9 percentage of subjects
Interval 38.7 to 49.2
|
44.2 percentage of subjects
Interval 39.0 to 49.5
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 56
|
44.4 percentage of subjects
Interval 39.2 to 49.7
|
42.5 percentage of subjects
Interval 37.3 to 47.8
|
45.3 percentage of subjects
Interval 40.1 to 50.6
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 60
|
41.6 percentage of subjects
Interval 36.5 to 46.9
|
45.6 percentage of subjects
Interval 40.3 to 50.9
|
43.6 percentage of subjects
Interval 38.4 to 48.9
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 64
|
43.0 percentage of subjects
Interval 37.8 to 48.3
|
44.7 percentage of subjects
Interval 39.5 to 50.0
|
40.6 percentage of subjects
Interval 35.4 to 45.8
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 68
|
44.7 percentage of subjects
Interval 39.5 to 50.0
|
44.2 percentage of subjects
Interval 39.0 to 49.5
|
43.6 percentage of subjects
Interval 38.4 to 48.9
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 72
|
45.3 percentage of subjects
Interval 40.0 to 50.6
|
41.9 percentage of subjects
Interval 36.8 to 47.2
|
41.9 percentage of subjects
Interval 36.8 to 47.2
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 76
|
45.0 percentage of subjects
Interval 39.7 to 50.3
|
44.4 percentage of subjects
Interval 39.2 to 49.7
|
44.4 percentage of subjects
Interval 39.2 to 49.7
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 80
|
41.3 percentage of subjects
Interval 36.2 to 46.6
|
43.6 percentage of subjects
Interval 38.4 to 48.9
|
43.3 percentage of subjects
Interval 38.1 to 48.6
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 84
|
43.3 percentage of subjects
Interval 38.1 to 48.6
|
42.8 percentage of subjects
Interval 37.6 to 48.1
|
42.2 percentage of subjects
Interval 37.1 to 47.5
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 88
|
44.4 percentage of subjects
Interval 39.2 to 49.7
|
43.6 percentage of subjects
Interval 38.4 to 48.9
|
41.7 percentage of subjects
Interval 36.5 to 46.9
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 92
|
44.1 percentage of subjects
Interval 38.9 to 49.4
|
43.3 percentage of subjects
Interval 38.1 to 48.6
|
40.8 percentage of subjects
Interval 35.7 to 46.1
|
|
Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 96
|
43.6 percentage of subjects
Interval 38.4 to 48.9
|
43.9 percentage of subjects
Interval 38.7 to 49.2
|
39.7 percentage of subjects
Interval 34.6 to 45.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 12
|
54.7 percentage of subjects
Interval 49.4 to 60.0
|
58.6 percentage of subjects
Interval 53.3 to 63.7
|
57.8 percentage of subjects
Interval 52.5 to 62.9
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 44
|
60.9 percentage of subjects
Interval 55.6 to 66.0
|
62.5 percentage of subjects
Interval 57.3 to 67.5
|
65.6 percentage of subjects
Interval 60.4 to 70.5
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 4
|
40.2 percentage of subjects
Interval 35.1 to 45.5
|
43.3 percentage of subjects
Interval 38.1 to 48.6
|
43.1 percentage of subjects
Interval 37.9 to 48.3
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 8
|
54.2 percentage of subjects
Interval 48.9 to 59.4
|
53.1 percentage of subjects
Interval 47.8 to 58.3
|
56.1 percentage of subjects
Interval 50.8 to 61.3
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 16
|
54.7 percentage of subjects
Interval 49.4 to 60.0
|
59.2 percentage of subjects
Interval 53.9 to 64.3
|
58.6 percentage of subjects
Interval 53.3 to 63.7
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 20
|
57.5 percentage of subjects
Interval 52.2 to 62.7
|
56.9 percentage of subjects
Interval 51.7 to 62.1
|
62.2 percentage of subjects
Interval 57.0 to 67.3
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 24
|
59.2 percentage of subjects
Interval 53.9 to 64.4
|
63.1 percentage of subjects
Interval 57.8 to 68.1
|
61.7 percentage of subjects
Interval 56.4 to 66.7
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 28
|
60.1 percentage of subjects
Interval 54.8 to 65.2
|
61.7 percentage of subjects
Interval 56.4 to 66.7
|
61.7 percentage of subjects
Interval 56.4 to 66.7
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 32
|
60.1 percentage of subjects
Interval 54.8 to 65.2
|
61.7 percentage of subjects
Interval 56.4 to 66.7
|
59.7 percentage of subjects
Interval 54.5 to 64.8
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 36
|
58.1 percentage of subjects
Interval 52.8 to 63.3
|
59.2 percentage of subjects
Interval 53.9 to 64.3
|
65.8 percentage of subjects
Interval 60.7 to 70.7
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 40
|
60.1 percentage of subjects
Interval 54.8 to 65.2
|
63.1 percentage of subjects
Interval 57.8 to 68.1
|
63.1 percentage of subjects
Interval 57.8 to 68.1
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 48
|
59.2 percentage of subjects
Interval 53.9 to 64.4
|
61.1 percentage of subjects
Interval 55.9 to 66.2
|
65.6 percentage of subjects
Interval 60.4 to 70.5
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 52
|
61.5 percentage of subjects
Interval 56.2 to 66.5
|
60.6 percentage of subjects
Interval 55.3 to 65.6
|
64.2 percentage of subjects
Interval 59.0 to 69.1
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 56
|
62.3 percentage of subjects
Interval 57.0 to 67.3
|
60.8 percentage of subjects
Interval 55.6 to 65.9
|
62.2 percentage of subjects
Interval 57.0 to 67.3
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 60
|
61.7 percentage of subjects
Interval 56.5 to 66.8
|
60.6 percentage of subjects
Interval 55.3 to 65.6
|
61.9 percentage of subjects
Interval 56.7 to 67.0
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 64
|
59.5 percentage of subjects
Interval 54.2 to 64.6
|
61.4 percentage of subjects
Interval 56.1 to 66.4
|
61.9 percentage of subjects
Interval 56.7 to 67.0
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 68
|
61.2 percentage of subjects
Interval 55.9 to 66.3
|
60.3 percentage of subjects
Interval 55.0 to 65.4
|
64.7 percentage of subjects
Interval 59.5 to 69.7
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 72
|
59.8 percentage of subjects
Interval 54.5 to 64.9
|
60.6 percentage of subjects
Interval 55.3 to 65.6
|
60.0 percentage of subjects
Interval 54.7 to 65.1
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 76
|
60.3 percentage of subjects
Interval 55.1 to 65.4
|
60.3 percentage of subjects
Interval 55.0 to 65.4
|
59.7 percentage of subjects
Interval 54.5 to 64.8
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 80
|
60.1 percentage of subjects
Interval 54.8 to 65.2
|
58.1 percentage of subjects
Interval 52.8 to 63.2
|
58.3 percentage of subjects
Interval 53.1 to 63.5
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 84
|
58.9 percentage of subjects
Interval 53.6 to 64.1
|
58.6 percentage of subjects
Interval 53.3 to 63.7
|
58.6 percentage of subjects
Interval 53.3 to 63.7
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 88
|
58.9 percentage of subjects
Interval 53.6 to 64.1
|
57.8 percentage of subjects
Interval 52.5 to 62.9
|
61.7 percentage of subjects
Interval 56.4 to 66.7
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 92
|
59.2 percentage of subjects
Interval 53.9 to 64.4
|
58.3 percentage of subjects
Interval 53.1 to 63.5
|
61.4 percentage of subjects
Interval 56.1 to 66.4
|
|
Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 96
|
61.7 percentage of subjects
Interval 56.5 to 66.8
|
58.1 percentage of subjects
Interval 52.8 to 63.2
|
58.6 percentage of subjects
Interval 53.3 to 63.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 20
|
2.5 percentage of subjects
Interval 1.2 to 4.7
|
4.7 percentage of subjects
Interval 2.8 to 7.5
|
2.5 percentage of subjects
Interval 1.1 to 4.7
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 24
|
4.2 percentage of subjects
Interval 2.4 to 6.8
|
5.3 percentage of subjects
Interval 3.2 to 8.1
|
3.9 percentage of subjects
Interval 2.1 to 6.4
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 28
|
4.7 percentage of subjects
Interval 2.8 to 7.5
|
5.6 percentage of subjects
Interval 3.4 to 8.4
|
4.4 percentage of subjects
Interval 2.6 to 7.1
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 32
|
5.3 percentage of subjects
Interval 3.2 to 8.2
|
6.4 percentage of subjects
Interval 4.1 to 9.4
|
4.2 percentage of subjects
Interval 2.4 to 6.8
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 36
|
4.7 percentage of subjects
Interval 2.8 to 7.5
|
6.4 percentage of subjects
Interval 4.1 to 9.4
|
3.3 percentage of subjects
Interval 1.7 to 5.8
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 40
|
5.0 percentage of subjects
Interval 3.0 to 7.8
|
6.9 percentage of subjects
Interval 4.5 to 10.1
|
4.2 percentage of subjects
Interval 2.4 to 6.8
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 44
|
5.6 percentage of subjects
Interval 3.4 to 8.5
|
6.4 percentage of subjects
Interval 4.1 to 9.4
|
4.4 percentage of subjects
Interval 2.6 to 7.1
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 48
|
5.9 percentage of subjects
Interval 3.7 to 8.8
|
6.4 percentage of subjects
Interval 4.1 to 9.4
|
5.6 percentage of subjects
Interval 3.4 to 8.4
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 52
|
6.1 percentage of subjects
Interval 3.9 to 9.2
|
6.9 percentage of subjects
Interval 4.5 to 10.1
|
5.8 percentage of subjects
Interval 3.6 to 8.8
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 56
|
6.4 percentage of subjects
Interval 4.1 to 9.5
|
7.8 percentage of subjects
Interval 5.2 to 11.0
|
5.3 percentage of subjects
Interval 3.2 to 8.1
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 60
|
5.9 percentage of subjects
Interval 3.7 to 8.8
|
6.9 percentage of subjects
Interval 4.5 to 10.1
|
5.8 percentage of subjects
Interval 3.6 to 8.8
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 64
|
7.3 percentage of subjects
Interval 4.8 to 10.5
|
8.6 percentage of subjects
Interval 5.9 to 12.0
|
5.8 percentage of subjects
Interval 3.6 to 8.8
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 68
|
7.3 percentage of subjects
Interval 4.8 to 10.5
|
7.5 percentage of subjects
Interval 5.0 to 10.7
|
6.4 percentage of subjects
Interval 4.1 to 9.4
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 72
|
7.3 percentage of subjects
Interval 4.8 to 10.5
|
7.5 percentage of subjects
Interval 5.0 to 10.7
|
6.1 percentage of subjects
Interval 3.9 to 9.1
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 76
|
6.7 percentage of subjects
Interval 4.3 to 9.8
|
8.1 percentage of subjects
Interval 5.5 to 11.4
|
6.1 percentage of subjects
Interval 3.9 to 9.1
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 80
|
7.3 percentage of subjects
Interval 4.8 to 10.5
|
7.8 percentage of subjects
Interval 5.2 to 11.0
|
8.1 percentage of subjects
Interval 5.5 to 11.4
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 84
|
8.7 percentage of subjects
Interval 6.0 to 12.1
|
7.8 percentage of subjects
Interval 5.2 to 11.0
|
7.2 percentage of subjects
Interval 4.8 to 10.4
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 88
|
8.7 percentage of subjects
Interval 6.0 to 12.1
|
8.1 percentage of subjects
Interval 5.5 to 11.4
|
8.1 percentage of subjects
Interval 5.5 to 11.4
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 92
|
8.7 percentage of subjects
Interval 6.0 to 12.1
|
8.1 percentage of subjects
Interval 5.5 to 11.4
|
6.9 percentage of subjects
Interval 4.5 to 10.1
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 96
|
8.7 percentage of subjects
Interval 6.0 to 12.1
|
8.1 percentage of subjects
Interval 5.5 to 11.4
|
7.5 percentage of subjects
Interval 5.0 to 10.7
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 4
|
1.7 percentage of subjects
Interval 0.6 to 3.6
|
3.1 percentage of subjects
Interval 1.5 to 5.4
|
1.4 percentage of subjects
Interval 0.5 to 3.2
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 8
|
1.7 percentage of subjects
Interval 0.6 to 3.6
|
2.8 percentage of subjects
Interval 1.3 to 5.0
|
2.2 percentage of subjects
Interval 1.0 to 4.3
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 12
|
3.4 percentage of subjects
Interval 1.7 to 5.8
|
3.6 percentage of subjects
Interval 1.9 to 6.1
|
3.9 percentage of subjects
Interval 2.1 to 6.4
|
|
Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 16
|
3.1 percentage of subjects
Interval 1.5 to 5.4
|
3.6 percentage of subjects
Interval 1.9 to 6.1
|
3.3 percentage of subjects
Interval 1.7 to 5.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 4
|
3.6 percentage of subjects
Interval 1.9 to 6.1
|
4.4 percentage of subjects
Interval 2.6 to 7.1
|
4.2 percentage of subjects
Interval 2.4 to 6.8
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 8
|
3.4 percentage of subjects
Interval 1.7 to 5.8
|
3.9 percentage of subjects
Interval 2.1 to 6.4
|
3.9 percentage of subjects
Interval 2.1 to 6.4
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 12
|
4.7 percentage of subjects
Interval 2.8 to 7.5
|
5.8 percentage of subjects
Interval 3.6 to 8.8
|
5.8 percentage of subjects
Interval 3.6 to 8.8
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 16
|
5.0 percentage of subjects
Interval 3.0 to 7.8
|
4.2 percentage of subjects
Interval 2.4 to 6.8
|
5.6 percentage of subjects
Interval 3.4 to 8.4
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 20
|
4.5 percentage of subjects
Interval 2.6 to 7.2
|
6.4 percentage of subjects
Interval 4.1 to 9.4
|
5.3 percentage of subjects
Interval 3.2 to 8.1
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 24
|
5.9 percentage of subjects
Interval 3.7 to 8.8
|
8.6 percentage of subjects
Interval 5.9 to 12.0
|
6.4 percentage of subjects
Interval 4.1 to 9.4
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 28
|
7.8 percentage of subjects
Interval 5.3 to 11.1
|
7.8 percentage of subjects
Interval 5.2 to 11.0
|
7.2 percentage of subjects
Interval 4.8 to 10.4
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 32
|
7.8 percentage of subjects
Interval 5.3 to 11.1
|
7.8 percentage of subjects
Interval 5.2 to 11.0
|
7.2 percentage of subjects
Interval 4.8 to 10.4
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 36
|
8.4 percentage of subjects
Interval 5.7 to 11.7
|
8.9 percentage of subjects
Interval 6.2 to 12.3
|
6.9 percentage of subjects
Interval 4.5 to 10.1
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 40
|
8.1 percentage of subjects
Interval 5.5 to 11.4
|
9.2 percentage of subjects
Interval 6.4 to 12.6
|
8.3 percentage of subjects
Interval 5.7 to 11.7
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 44
|
8.7 percentage of subjects
Interval 6.0 to 12.1
|
8.6 percentage of subjects
Interval 5.9 to 12.0
|
8.1 percentage of subjects
Interval 5.5 to 11.4
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 48
|
9.5 percentage of subjects
Interval 6.7 to 13.0
|
8.9 percentage of subjects
Interval 6.2 to 12.3
|
7.5 percentage of subjects
Interval 5.0 to 10.7
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 52
|
8.9 percentage of subjects
Interval 6.2 to 12.4
|
11.1 percentage of subjects
Interval 8.1 to 14.8
|
8.3 percentage of subjects
Interval 5.7 to 11.7
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 56
|
9.8 percentage of subjects
Interval 6.9 to 13.3
|
10.3 percentage of subjects
Interval 7.3 to 13.9
|
7.8 percentage of subjects
Interval 5.2 to 11.0
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 60
|
8.9 percentage of subjects
Interval 6.2 to 12.4
|
10.6 percentage of subjects
Interval 7.6 to 14.2
|
9.4 percentage of subjects
Interval 6.6 to 12.9
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 64
|
10.6 percentage of subjects
Interval 7.6 to 14.3
|
11.1 percentage of subjects
Interval 8.1 to 14.8
|
9.2 percentage of subjects
Interval 6.4 to 12.6
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 68
|
10.3 percentage of subjects
Interval 7.4 to 14.0
|
11.4 percentage of subjects
Interval 8.3 to 15.1
|
9.2 percentage of subjects
Interval 6.4 to 12.6
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 72
|
10.3 percentage of subjects
Interval 7.4 to 14.0
|
11.1 percentage of subjects
Interval 8.1 to 14.8
|
12.2 percentage of subjects
Interval 9.0 to 16.1
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 76
|
8.9 percentage of subjects
Interval 6.2 to 12.4
|
12.2 percentage of subjects
Interval 9.0 to 16.1
|
10.0 percentage of subjects
Interval 7.1 to 13.6
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 80
|
9.8 percentage of subjects
Interval 6.9 to 13.3
|
12.5 percentage of subjects
Interval 9.3 to 16.4
|
10.8 percentage of subjects
Interval 7.8 to 14.5
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 84
|
11.5 percentage of subjects
Interval 8.3 to 15.2
|
12.8 percentage of subjects
Interval 9.5 to 16.7
|
10.8 percentage of subjects
Interval 7.8 to 14.5
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 88
|
11.7 percentage of subjects
Interval 8.6 to 15.5
|
12.2 percentage of subjects
Interval 9.0 to 16.1
|
12.2 percentage of subjects
Interval 9.0 to 16.1
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 92
|
11.5 percentage of subjects
Interval 8.3 to 15.2
|
11.7 percentage of subjects
Interval 8.5 to 15.4
|
11.9 percentage of subjects
Interval 8.8 to 15.8
|
|
Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 96
|
12.0 percentage of subjects
Interval 8.8 to 15.8
|
14.7 percentage of subjects
Interval 11.2 to 18.8
|
12.5 percentage of subjects
Interval 9.3 to 16.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 4
|
9.8 percentage of subjects
Interval 6.9 to 13.3
|
10.3 percentage of subjects
Interval 7.3 to 13.9
|
7.8 percentage of subjects
Interval 5.2 to 11.0
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 8
|
7.5 percentage of subjects
Interval 5.0 to 10.8
|
10.3 percentage of subjects
Interval 7.3 to 13.9
|
7.5 percentage of subjects
Interval 5.0 to 10.7
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 12
|
10.3 percentage of subjects
Interval 7.4 to 14.0
|
11.9 percentage of subjects
Interval 8.8 to 15.8
|
8.3 percentage of subjects
Interval 5.7 to 11.7
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 16
|
10.3 percentage of subjects
Interval 7.4 to 14.0
|
9.4 percentage of subjects
Interval 6.6 to 12.9
|
10.8 percentage of subjects
Interval 7.8 to 14.5
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 20
|
8.7 percentage of subjects
Interval 6.0 to 12.1
|
11.9 percentage of subjects
Interval 8.8 to 15.8
|
10.0 percentage of subjects
Interval 7.1 to 13.6
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 24
|
10.3 percentage of subjects
Interval 7.4 to 14.0
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
11.1 percentage of subjects
Interval 8.1 to 14.8
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 28
|
10.6 percentage of subjects
Interval 7.6 to 14.3
|
13.6 percentage of subjects
Interval 10.2 to 17.6
|
12.8 percentage of subjects
Interval 9.5 to 16.7
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 32
|
12.8 percentage of subjects
Interval 9.6 to 16.8
|
12.2 percentage of subjects
Interval 9.0 to 16.1
|
13.3 percentage of subjects
Interval 10.0 to 17.3
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 36
|
14.0 percentage of subjects
Interval 10.5 to 18.0
|
13.1 percentage of subjects
Interval 9.8 to 17.0
|
10.8 percentage of subjects
Interval 7.8 to 14.5
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 40
|
12.0 percentage of subjects
Interval 8.8 to 15.8
|
13.6 percentage of subjects
Interval 10.2 to 17.6
|
13.1 percentage of subjects
Interval 9.8 to 17.0
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 44
|
13.7 percentage of subjects
Interval 10.3 to 17.7
|
12.8 percentage of subjects
Interval 9.5 to 16.7
|
14.4 percentage of subjects
Interval 11.0 to 18.5
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 48
|
13.7 percentage of subjects
Interval 10.3 to 17.7
|
12.5 percentage of subjects
Interval 9.3 to 16.4
|
11.7 percentage of subjects
Interval 8.5 to 15.4
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 52
|
14.0 percentage of subjects
Interval 10.5 to 18.0
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
13.6 percentage of subjects
Interval 10.2 to 17.6
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 56
|
13.4 percentage of subjects
Interval 10.1 to 17.4
|
13.9 percentage of subjects
Interval 10.5 to 17.9
|
12.5 percentage of subjects
Interval 9.3 to 16.4
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 60
|
13.7 percentage of subjects
Interval 10.3 to 17.7
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
13.3 percentage of subjects
Interval 10.0 to 17.3
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 64
|
15.4 percentage of subjects
Interval 11.8 to 19.5
|
16.1 percentage of subjects
Interval 12.5 to 20.3
|
13.3 percentage of subjects
Interval 10.0 to 17.3
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 68
|
14.2 percentage of subjects
Interval 10.8 to 18.3
|
15.3 percentage of subjects
Interval 11.7 to 19.4
|
14.7 percentage of subjects
Interval 11.2 to 18.8
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 72
|
15.9 percentage of subjects
Interval 12.3 to 20.1
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
14.7 percentage of subjects
Interval 11.2 to 18.8
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 76
|
15.9 percentage of subjects
Interval 12.3 to 20.1
|
16.1 percentage of subjects
Interval 12.5 to 20.3
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 80
|
16.2 percentage of subjects
Interval 12.5 to 20.4
|
16.7 percentage of subjects
Interval 13.0 to 20.9
|
15.6 percentage of subjects
Interval 12.0 to 19.7
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 84
|
17.9 percentage of subjects
Interval 14.0 to 22.2
|
19.2 percentage of subjects
Interval 15.2 to 23.6
|
15.8 percentage of subjects
Interval 12.2 to 20.0
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 88
|
17.0 percentage of subjects
Interval 13.3 to 21.3
|
17.5 percentage of subjects
Interval 13.7 to 21.8
|
16.1 percentage of subjects
Interval 12.5 to 20.3
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 92
|
17.3 percentage of subjects
Interval 13.5 to 21.6
|
17.5 percentage of subjects
Interval 13.7 to 21.8
|
16.1 percentage of subjects
Interval 12.5 to 20.3
|
|
Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 96
|
20.4 percentage of subjects
Interval 16.3 to 24.9
|
18.9 percentage of subjects
Interval 15.0 to 23.3
|
17.2 percentage of subjects
Interval 13.5 to 21.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS-LOCF
BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Baseline
|
24.9 percentage of subjects
Interval 20.5 to 29.7
|
21.7 percentage of subjects
Interval 17.5 to 26.3
|
19.2 percentage of subjects
Interval 15.2 to 23.6
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 4
|
34.6 percentage of subjects
Interval 29.7 to 39.8
|
33.3 percentage of subjects
Interval 28.5 to 38.5
|
33.9 percentage of subjects
Interval 29.0 to 39.0
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 8
|
42.5 percentage of subjects
Interval 37.3 to 47.8
|
42.8 percentage of subjects
Interval 37.6 to 48.1
|
42.8 percentage of subjects
Interval 37.6 to 48.1
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 12
|
45.3 percentage of subjects
Interval 40.0 to 50.6
|
43.9 percentage of subjects
Interval 38.7 to 49.2
|
45.8 percentage of subjects
Interval 40.6 to 51.1
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 16
|
46.4 percentage of subjects
Interval 41.1 to 51.7
|
46.7 percentage of subjects
Interval 41.4 to 52.0
|
44.4 percentage of subjects
Interval 39.2 to 49.7
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 20
|
46.4 percentage of subjects
Interval 41.1 to 51.7
|
46.9 percentage of subjects
Interval 41.7 to 52.2
|
48.1 percentage of subjects
Interval 42.8 to 53.4
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 24
|
49.7 percentage of subjects
Interval 44.4 to 55.0
|
47.8 percentage of subjects
Interval 42.5 to 53.1
|
46.4 percentage of subjects
Interval 41.1 to 51.7
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 28
|
48.9 percentage of subjects
Interval 43.6 to 54.2
|
49.7 percentage of subjects
Interval 44.4 to 55.0
|
46.9 percentage of subjects
Interval 41.7 to 52.2
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 32
|
48.0 percentage of subjects
Interval 42.8 to 53.4
|
51.4 percentage of subjects
Interval 46.1 to 56.7
|
44.4 percentage of subjects
Interval 39.2 to 49.7
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 36
|
47.8 percentage of subjects
Interval 42.5 to 53.1
|
50.6 percentage of subjects
Interval 45.3 to 55.8
|
48.3 percentage of subjects
Interval 43.1 to 53.6
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 40
|
51.7 percentage of subjects
Interval 46.4 to 57.0
|
49.2 percentage of subjects
Interval 43.9 to 54.5
|
48.6 percentage of subjects
Interval 43.3 to 53.9
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 44
|
49.7 percentage of subjects
Interval 44.4 to 55.0
|
50.0 percentage of subjects
Interval 44.7 to 55.3
|
50.3 percentage of subjects
Interval 45.0 to 55.6
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 48
|
49.7 percentage of subjects
Interval 44.4 to 55.0
|
50.6 percentage of subjects
Interval 45.3 to 55.8
|
50.8 percentage of subjects
Interval 45.5 to 56.1
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 52
|
48.6 percentage of subjects
Interval 43.3 to 53.9
|
50.6 percentage of subjects
Interval 45.3 to 55.8
|
49.2 percentage of subjects
Interval 43.9 to 54.5
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 56
|
50.8 percentage of subjects
Interval 45.5 to 56.1
|
50.0 percentage of subjects
Interval 44.7 to 55.3
|
48.6 percentage of subjects
Interval 43.3 to 53.9
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 60
|
52.0 percentage of subjects
Interval 46.6 to 57.2
|
48.1 percentage of subjects
Interval 42.8 to 53.4
|
49.2 percentage of subjects
Interval 43.9 to 54.5
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 64
|
50.8 percentage of subjects
Interval 45.5 to 56.1
|
50.6 percentage of subjects
Interval 45.3 to 55.8
|
49.2 percentage of subjects
Interval 43.9 to 54.5
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 68
|
50.6 percentage of subjects
Interval 45.3 to 55.9
|
48.3 percentage of subjects
Interval 43.1 to 53.6
|
46.7 percentage of subjects
Interval 41.4 to 52.0
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 72
|
50.8 percentage of subjects
Interval 45.5 to 56.1
|
49.2 percentage of subjects
Interval 43.9 to 54.5
|
49.4 percentage of subjects
Interval 44.2 to 54.7
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 76
|
52.2 percentage of subjects
Interval 46.9 to 57.5
|
49.2 percentage of subjects
Interval 43.9 to 54.5
|
46.1 percentage of subjects
Interval 40.9 to 51.4
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 80
|
51.4 percentage of subjects
Interval 46.1 to 56.7
|
49.7 percentage of subjects
Interval 44.4 to 55.0
|
45.6 percentage of subjects
Interval 40.3 to 50.9
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 84
|
50.6 percentage of subjects
Interval 45.3 to 55.9
|
47.2 percentage of subjects
Interval 42.0 to 52.5
|
45.3 percentage of subjects
Interval 40.1 to 50.6
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 88
|
50.6 percentage of subjects
Interval 45.3 to 55.9
|
50.3 percentage of subjects
Interval 45.0 to 55.6
|
48.6 percentage of subjects
Interval 43.3 to 53.9
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 92
|
51.7 percentage of subjects
Interval 46.4 to 57.0
|
49.4 percentage of subjects
Interval 44.2 to 54.7
|
45.8 percentage of subjects
Interval 40.6 to 51.1
|
|
Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye
Week 96
|
48.9 percentage of subjects
Interval 43.6 to 54.2
|
49.4 percentage of subjects
Interval 44.2 to 54.7
|
45.6 percentage of subjects
Interval 40.3 to 50.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 40
|
-164.3 micrometers
Standard Deviation 153.85
|
-166.9 micrometers
Standard Deviation 141.94
|
-141.1 micrometers
Standard Deviation 144.80
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 44
|
-165.1 micrometers
Standard Deviation 151.34
|
-167.4 micrometers
Standard Deviation 156.10
|
-160.3 micrometers
Standard Deviation 139.14
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 4
|
-142.2 micrometers
Standard Deviation 130.54
|
-150.9 micrometers
Standard Deviation 120.85
|
-137.8 micrometers
Standard Deviation 120.62
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 8
|
-163.7 micrometers
Standard Deviation 139.68
|
-169.1 micrometers
Standard Deviation 132.62
|
-154.3 micrometers
Standard Deviation 126.05
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 12
|
-172.5 micrometers
Standard Deviation 142.82
|
-177.6 micrometers
Standard Deviation 137.13
|
-157.3 micrometers
Standard Deviation 125.86
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 16
|
-151.4 micrometers
Standard Deviation 145.66
|
-159.6 micrometers
Standard Deviation 133.91
|
-135.3 micrometers
Standard Deviation 132.50
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 20
|
-151.5 micrometers
Standard Deviation 142.70
|
-153.8 micrometers
Standard Deviation 144.23
|
-161.1 micrometers
Standard Deviation 128.75
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 24
|
-160.4 micrometers
Standard Deviation 151.33
|
-164.6 micrometers
Standard Deviation 141.67
|
-138.9 micrometers
Standard Deviation 136.02
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 28
|
-169.1 micrometers
Standard Deviation 147.81
|
-169.7 micrometers
Standard Deviation 146.82
|
-161.8 micrometers
Standard Deviation 133.79
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 32
|
-153.9 micrometers
Standard Deviation 154.59
|
-157.0 micrometers
Standard Deviation 144.46
|
-137.5 micrometers
Standard Deviation 142.15
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 36
|
-173.0 micrometers
Standard Deviation 150.80
|
-175.3 micrometers
Standard Deviation 147.18
|
-160.2 micrometers
Standard Deviation 137.94
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 48
|
-165.3 micrometers
Standard Deviation 152.86
|
-170.9 micrometers
Standard Deviation 142.48
|
-145.6 micrometers
Standard Deviation 145.53
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 52
|
-174.4 micrometers
Standard Deviation 149.06
|
-173.8 micrometers
Standard Deviation 149.18
|
-162.9 micrometers
Standard Deviation 141.57
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 56
|
-161.7 micrometers
Standard Deviation 148.33
|
-161.6 micrometers
Standard Deviation 149.26
|
-145.5 micrometers
Standard Deviation 145.95
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 60
|
-177.4 micrometers
Standard Deviation 150.58
|
-171.3 micrometers
Standard Deviation 152.35
|
-162.8 micrometers
Standard Deviation 143.92
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 64
|
-170.8 micrometers
Standard Deviation 160.61
|
-166.2 micrometers
Standard Deviation 148.96
|
-147.6 micrometers
Standard Deviation 145.88
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 68
|
-171.7 micrometers
Standard Deviation 149.54
|
-169.8 micrometers
Standard Deviation 151.91
|
-160.6 micrometers
Standard Deviation 150.34
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 72
|
-173.0 micrometers
Standard Deviation 152.01
|
-169.5 micrometers
Standard Deviation 149.17
|
-146.8 micrometers
Standard Deviation 151.89
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 76
|
-176.6 micrometers
Standard Deviation 154.87
|
-172.9 micrometers
Standard Deviation 153.90
|
-161.4 micrometers
Standard Deviation 147.50
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 80
|
-168.4 micrometers
Standard Deviation 157.11
|
-167.1 micrometers
Standard Deviation 152.62
|
-147.2 micrometers
Standard Deviation 156.73
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 84
|
-181.7 micrometers
Standard Deviation 152.44
|
-173.9 micrometers
Standard Deviation 157.54
|
-166.4 micrometers
Standard Deviation 151.94
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 88
|
-174.3 micrometers
Standard Deviation 154.83
|
-171.1 micrometers
Standard Deviation 152.31
|
-150.9 micrometers
Standard Deviation 157.20
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 92
|
-176.9 micrometers
Standard Deviation 154.63
|
-174.1 micrometers
Standard Deviation 157.30
|
-165.8 micrometers
Standard Deviation 150.35
|
|
Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 96
|
-177.8 micrometers
Standard Deviation 155.03
|
-172.9 micrometers
Standard Deviation 156.38
|
-150.7 micrometers
Standard Deviation 154.86
|
SECONDARY outcome
Timeframe: Baseline, Weeks 36, 40, 44, 48Population: FAS - LOCF
CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Average Change From Baseline in CSFTtot Over the Period Week 36 Through Week 48 - Study Eye
|
-166.9 micrometers
Standard Deviation 148.90
|
-170.1 micrometers
Standard Deviation 143.48
|
-151.8 micrometers
Standard Deviation 139.53
|
SECONDARY outcome
Timeframe: Baseline, Weeks 84, 88, 92, 96Population: FAS - LOCF
CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Average Change From Baseline in CSFTtot Over the Period Week 84 Through Week 96 - Study Eye
|
-177.7 micrometers
Standard Deviation 153.15
|
-173.0 micrometers
Standard Deviation 154.47
|
-158.4 micrometers
Standard Deviation 151.86
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Average Change From Baseline in CSFTtot Over the Period Week 4 Through Week 48/96 - Study Eye
Change from baseline over the period Week 4 to 48
|
-161.0 micrometers
Standard Deviation 138.65
|
-165.2 micrometers
Standard Deviation 135.36
|
-149.3 micrometers
Standard Deviation 128.16
|
|
Average Change From Baseline in CSFTtot Over the Period Week 4 Through Week 48/96 - Study Eye
Change from baseline over the period Week 4 to 96
|
-167.5 micrometers
Standard Deviation 143.12
|
-167.8 micrometers
Standard Deviation 141.23
|
-152.4 micrometers
Standard Deviation 135.75
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 48, 96Population: FAS - LOCF. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.
CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye
Change from baseline at Week 12
|
-3.3 millimeters squared
Standard Deviation 4.15
|
-3.8 millimeters squared
Standard Deviation 3.89
|
-3.2 millimeters squared
Standard Deviation 3.45
|
|
Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye
Change from baseline at Week 48
|
-3.9 millimeters squared
Standard Deviation 4.59
|
-4.0 millimeters squared
Standard Deviation 3.89
|
-3.5 millimeters squared
Standard Deviation 4.03
|
|
Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye
Change from baseline at Week 96
|
-3.9 millimeters squared
Standard Deviation 4.62
|
-4.1 millimeters squared
Standard Deviation 4.07
|
-3.5 millimeters squared
Standard Deviation 4.17
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
Central subfield neurosensory retinal thickness was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 4
|
-56.3 micrometers
Standard Deviation 86.09
|
-62.1 micrometers
Standard Deviation 88.73
|
-61.0 micrometers
Standard Deviation 85.59
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 8
|
-63.7 micrometers
Standard Deviation 87.09
|
-66.3 micrometers
Standard Deviation 93.11
|
-63.2 micrometers
Standard Deviation 88.65
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 12
|
-67.0 micrometers
Standard Deviation 88.75
|
-68.3 micrometers
Standard Deviation 94.14
|
-63.7 micrometers
Standard Deviation 88.73
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 16
|
-57.2 micrometers
Standard Deviation 91.00
|
-61.1 micrometers
Standard Deviation 92.12
|
-54.9 micrometers
Standard Deviation 91.55
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 20
|
-58.6 micrometers
Standard Deviation 90.20
|
-59.4 micrometers
Standard Deviation 91.78
|
-65.5 micrometers
Standard Deviation 89.46
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 24
|
-63.4 micrometers
Standard Deviation 91.06
|
-65.0 micrometers
Standard Deviation 97.16
|
-57.3 micrometers
Standard Deviation 91.89
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 28
|
-67.9 micrometers
Standard Deviation 92.89
|
-66.1 micrometers
Standard Deviation 98.08
|
-67.2 micrometers
Standard Deviation 89.40
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 32
|
-58.6 micrometers
Standard Deviation 93.16
|
-60.4 micrometers
Standard Deviation 97.42
|
-59.0 micrometers
Standard Deviation 90.77
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 36
|
-67.4 micrometers
Standard Deviation 94.43
|
-69.2 micrometers
Standard Deviation 100.29
|
-67.1 micrometers
Standard Deviation 92.55
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 40
|
-64.0 micrometers
Standard Deviation 93.94
|
-67.0 micrometers
Standard Deviation 98.18
|
-61.8 micrometers
Standard Deviation 90.60
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 44
|
-65.2 micrometers
Standard Deviation 91.89
|
-67.4 micrometers
Standard Deviation 99.33
|
-67.5 micrometers
Standard Deviation 92.08
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 48
|
-66.3 micrometers
Standard Deviation 95.57
|
-66.4 micrometers
Standard Deviation 98.85
|
-64.3 micrometers
Standard Deviation 92.86
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 52
|
-70.4 micrometers
Standard Deviation 95.07
|
-69.8 micrometers
Standard Deviation 100.94
|
-69.5 micrometers
Standard Deviation 94.15
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 56
|
-66.9 micrometers
Standard Deviation 95.57
|
-65.0 micrometers
Standard Deviation 100.26
|
-65.2 micrometers
Standard Deviation 93.33
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 60
|
-73.0 micrometers
Standard Deviation 97.26
|
-69.0 micrometers
Standard Deviation 102.69
|
-69.9 micrometers
Standard Deviation 95.32
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 64
|
-69.5 micrometers
Standard Deviation 97.07
|
-68.3 micrometers
Standard Deviation 101.20
|
-66.5 micrometers
Standard Deviation 94.25
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 68
|
-69.5 micrometers
Standard Deviation 97.06
|
-68.4 micrometers
Standard Deviation 101.24
|
-69.0 micrometers
Standard Deviation 94.73
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 72
|
-70.8 micrometers
Standard Deviation 96.61
|
-68.4 micrometers
Standard Deviation 99.73
|
-65.1 micrometers
Standard Deviation 94.75
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 76
|
-70.0 micrometers
Standard Deviation 101.51
|
-70.8 micrometers
Standard Deviation 102.45
|
-69.1 micrometers
Standard Deviation 95.26
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 80
|
-67.2 micrometers
Standard Deviation 102.52
|
-68.2 micrometers
Standard Deviation 100.77
|
-67.1 micrometers
Standard Deviation 92.06
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 84
|
-72.7 micrometers
Standard Deviation 101.96
|
-71.3 micrometers
Standard Deviation 102.48
|
-69.6 micrometers
Standard Deviation 93.53
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 88
|
-71.5 micrometers
Standard Deviation 98.52
|
-69.3 micrometers
Standard Deviation 100.95
|
-66.9 micrometers
Standard Deviation 93.64
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 92
|
-71.6 micrometers
Standard Deviation 99.16
|
-71.2 micrometers
Standard Deviation 104.98
|
-70.3 micrometers
Standard Deviation 93.71
|
|
Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye
Change from baseline at Week 96
|
-71.8 micrometers
Standard Deviation 99.15
|
-70.4 micrometers
Standard Deviation 101.71
|
-64.9 micrometers
Standard Deviation 94.21
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 4
|
33.2 percentage of subjects
Interval 28.4 to 38.4
|
28.9 percentage of subjects
Interval 24.3 to 33.9
|
42.8 percentage of subjects
Interval 37.6 to 48.1
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 8
|
19.0 percentage of subjects
Interval 15.1 to 23.4
|
12.8 percentage of subjects
Interval 9.5 to 16.7
|
27.5 percentage of subjects
Interval 23.0 to 32.4
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 12
|
14.8 percentage of subjects
Interval 11.3 to 18.9
|
9.2 percentage of subjects
Interval 6.4 to 12.6
|
23.1 percentage of subjects
Interval 18.8 to 27.8
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 16
|
26.0 percentage of subjects
Interval 21.5 to 30.8
|
16.9 percentage of subjects
Interval 13.2 to 21.2
|
36.7 percentage of subjects
Interval 31.7 to 41.9
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 20
|
26.3 percentage of subjects
Interval 21.8 to 31.1
|
24.4 percentage of subjects
Interval 20.1 to 29.2
|
22.2 percentage of subjects
Interval 18.0 to 26.9
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 24
|
23.5 percentage of subjects
Interval 19.2 to 28.2
|
13.1 percentage of subjects
Interval 9.8 to 17.0
|
36.4 percentage of subjects
Interval 31.4 to 41.6
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 28
|
18.4 percentage of subjects
Interval 14.6 to 22.8
|
16.4 percentage of subjects
Interval 12.7 to 20.6
|
21.4 percentage of subjects
Interval 17.3 to 26.0
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 32
|
28.2 percentage of subjects
Interval 23.6 to 33.2
|
23.9 percentage of subjects
Interval 19.6 to 28.6
|
36.1 percentage of subjects
Interval 31.1 to 41.3
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 36
|
14.2 percentage of subjects
Interval 10.8 to 18.3
|
11.9 percentage of subjects
Interval 8.8 to 15.8
|
22.2 percentage of subjects
Interval 18.0 to 26.9
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 40
|
21.5 percentage of subjects
Interval 17.4 to 26.1
|
16.1 percentage of subjects
Interval 12.5 to 20.3
|
27.5 percentage of subjects
Interval 23.0 to 32.4
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 44
|
20.1 percentage of subjects
Interval 16.1 to 24.6
|
16.4 percentage of subjects
Interval 12.7 to 20.6
|
19.4 percentage of subjects
Interval 15.5 to 23.9
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 48
|
18.2 percentage of subjects
Interval 14.3 to 22.5
|
14.4 percentage of subjects
Interval 11.0 to 18.5
|
30.0 percentage of subjects
Interval 25.3 to 35.0
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 52
|
15.9 percentage of subjects
Interval 12.3 to 20.1
|
10.0 percentage of subjects
Interval 7.1 to 13.6
|
18.6 percentage of subjects
Interval 14.7 to 23.0
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 56
|
20.4 percentage of subjects
Interval 16.3 to 24.9
|
18.1 percentage of subjects
Interval 14.2 to 22.4
|
27.5 percentage of subjects
Interval 23.0 to 32.4
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 60
|
14.2 percentage of subjects
Interval 10.8 to 18.3
|
10.3 percentage of subjects
Interval 7.3 to 13.9
|
18.9 percentage of subjects
Interval 15.0 to 23.3
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 64
|
18.7 percentage of subjects
Interval 14.8 to 23.1
|
14.4 percentage of subjects
Interval 11.0 to 18.5
|
26.4 percentage of subjects
Interval 21.9 to 31.3
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 68
|
18.4 percentage of subjects
Interval 14.6 to 22.8
|
14.4 percentage of subjects
Interval 11.0 to 18.5
|
15.8 percentage of subjects
Interval 12.2 to 20.0
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 72
|
16.2 percentage of subjects
Interval 12.5 to 20.4
|
11.4 percentage of subjects
Interval 8.3 to 15.1
|
23.9 percentage of subjects
Interval 19.6 to 28.6
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 76
|
15.9 percentage of subjects
Interval 12.3 to 20.1
|
11.7 percentage of subjects
Interval 8.5 to 15.4
|
17.5 percentage of subjects
Interval 13.7 to 21.8
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 80
|
17.6 percentage of subjects
Interval 13.8 to 21.9
|
12.2 percentage of subjects
Interval 9.0 to 16.1
|
23.9 percentage of subjects
Interval 19.6 to 28.6
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 84
|
12.0 percentage of subjects
Interval 8.8 to 15.8
|
12.2 percentage of subjects
Interval 9.0 to 16.1
|
17.2 percentage of subjects
Interval 13.5 to 21.5
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 88
|
17.3 percentage of subjects
Interval 13.5 to 21.6
|
11.7 percentage of subjects
Interval 8.5 to 15.4
|
23.3 percentage of subjects
Interval 19.1 to 28.1
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 92
|
15.9 percentage of subjects
Interval 12.3 to 20.1
|
10.0 percentage of subjects
Interval 7.1 to 13.6
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
|
Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye
Week 96
|
15.6 percentage of subjects
Interval 12.0 to 19.8
|
10.3 percentage of subjects
Interval 7.3 to 13.9
|
21.4 percentage of subjects
Interval 17.3 to 26.0
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 4
|
20.4 percentage of subjects
Interval 16.3 to 24.9
|
23.9 percentage of subjects
Interval 19.6 to 28.6
|
22.2 percentage of subjects
Interval 18.0 to 26.9
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 8
|
17.9 percentage of subjects
Interval 14.0 to 22.2
|
20.8 percentage of subjects
Interval 16.8 to 25.4
|
22.5 percentage of subjects
Interval 18.3 to 27.2
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 12
|
14.2 percentage of subjects
Interval 10.8 to 18.3
|
17.2 percentage of subjects
Interval 13.5 to 21.5
|
16.9 percentage of subjects
Interval 13.2 to 21.2
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 16
|
22.3 percentage of subjects
Interval 18.1 to 27.0
|
20.3 percentage of subjects
Interval 16.2 to 24.8
|
24.7 percentage of subjects
Interval 20.4 to 29.5
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 20
|
25.7 percentage of subjects
Interval 21.2 to 30.6
|
25.0 percentage of subjects
Interval 20.6 to 29.8
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 24
|
22.9 percentage of subjects
Interval 18.7 to 27.6
|
17.8 percentage of subjects
Interval 14.0 to 22.1
|
26.9 percentage of subjects
Interval 22.4 to 31.8
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 28
|
21.8 percentage of subjects
Interval 17.6 to 26.4
|
18.1 percentage of subjects
Interval 14.2 to 22.4
|
18.9 percentage of subjects
Interval 15.0 to 23.3
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 32
|
24.6 percentage of subjects
Interval 20.2 to 29.4
|
21.9 percentage of subjects
Interval 17.8 to 26.6
|
24.4 percentage of subjects
Interval 20.1 to 29.2
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 36
|
17.9 percentage of subjects
Interval 14.0 to 22.2
|
16.4 percentage of subjects
Interval 12.7 to 20.6
|
18.6 percentage of subjects
Interval 14.7 to 23.0
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 40
|
20.7 percentage of subjects
Interval 16.6 to 25.2
|
19.7 percentage of subjects
Interval 15.7 to 24.2
|
24.2 percentage of subjects
Interval 19.8 to 28.9
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 44
|
21.5 percentage of subjects
Interval 17.4 to 26.1
|
18.6 percentage of subjects
Interval 14.7 to 23.0
|
16.7 percentage of subjects
Interval 13.0 to 20.9
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 48
|
21.8 percentage of subjects
Interval 17.6 to 26.4
|
21.4 percentage of subjects
Interval 17.3 to 26.0
|
22.2 percentage of subjects
Interval 18.0 to 26.9
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 52
|
18.4 percentage of subjects
Interval 14.6 to 22.8
|
16.9 percentage of subjects
Interval 13.2 to 21.2
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 56
|
23.7 percentage of subjects
Interval 19.4 to 28.5
|
20.8 percentage of subjects
Interval 16.8 to 25.4
|
21.1 percentage of subjects
Interval 17.0 to 25.7
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 60
|
15.1 percentage of subjects
Interval 11.5 to 19.2
|
15.8 percentage of subjects
Interval 12.2 to 20.0
|
16.4 percentage of subjects
Interval 12.7 to 20.6
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 64
|
20.4 percentage of subjects
Interval 16.3 to 24.9
|
17.8 percentage of subjects
Interval 14.0 to 22.1
|
20.8 percentage of subjects
Interval 16.8 to 25.4
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 68
|
19.8 percentage of subjects
Interval 15.8 to 24.3
|
16.4 percentage of subjects
Interval 12.7 to 20.6
|
14.2 percentage of subjects
Interval 10.7 to 18.2
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 72
|
17.6 percentage of subjects
Interval 13.8 to 21.9
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
18.3 percentage of subjects
Interval 14.5 to 22.7
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 76
|
17.3 percentage of subjects
Interval 13.5 to 21.6
|
15.6 percentage of subjects
Interval 12.0 to 19.7
|
14.2 percentage of subjects
Interval 10.7 to 18.2
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 80
|
19.3 percentage of subjects
Interval 15.3 to 23.7
|
18.6 percentage of subjects
Interval 14.7 to 23.0
|
18.3 percentage of subjects
Interval 14.5 to 22.7
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 84
|
16.8 percentage of subjects
Interval 13.0 to 21.0
|
14.2 percentage of subjects
Interval 10.7 to 18.2
|
14.4 percentage of subjects
Interval 11.0 to 18.5
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 88
|
20.7 percentage of subjects
Interval 16.6 to 25.2
|
16.7 percentage of subjects
Interval 13.0 to 20.9
|
16.7 percentage of subjects
Interval 13.0 to 20.9
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 92
|
17.6 percentage of subjects
Interval 13.8 to 21.9
|
14.4 percentage of subjects
Interval 11.0 to 18.5
|
13.6 percentage of subjects
Interval 10.2 to 17.6
|
|
Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 96
|
19.3 percentage of subjects
Interval 15.3 to 23.7
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
20.0 percentage of subjects
Interval 16.0 to 24.5
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
Sub-RPE fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 4
|
25.4 percentage of subjects
Interval 21.0 to 30.3
|
24.2 percentage of subjects
Interval 19.8 to 28.9
|
29.2 percentage of subjects
Interval 24.5 to 34.2
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 8
|
16.5 percentage of subjects
Interval 12.8 to 20.7
|
17.5 percentage of subjects
Interval 13.7 to 21.8
|
21.4 percentage of subjects
Interval 17.3 to 26.0
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 12
|
13.7 percentage of subjects
Interval 10.3 to 17.7
|
14.2 percentage of subjects
Interval 10.7 to 18.2
|
21.1 percentage of subjects
Interval 17.0 to 25.7
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 16
|
19.3 percentage of subjects
Interval 15.3 to 23.7
|
18.9 percentage of subjects
Interval 15.0 to 23.3
|
26.9 percentage of subjects
Interval 22.4 to 31.8
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 20
|
19.8 percentage of subjects
Interval 15.8 to 24.3
|
20.6 percentage of subjects
Interval 16.5 to 25.1
|
17.8 percentage of subjects
Interval 14.0 to 22.1
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 24
|
17.3 percentage of subjects
Interval 13.5 to 21.6
|
16.1 percentage of subjects
Interval 12.5 to 20.3
|
22.8 percentage of subjects
Interval 18.5 to 27.5
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 28
|
18.7 percentage of subjects
Interval 14.8 to 23.1
|
15.6 percentage of subjects
Interval 12.0 to 19.7
|
18.3 percentage of subjects
Interval 14.5 to 22.7
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 32
|
19.8 percentage of subjects
Interval 15.8 to 24.3
|
19.7 percentage of subjects
Interval 15.7 to 24.2
|
21.4 percentage of subjects
Interval 17.3 to 26.0
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 36
|
12.8 percentage of subjects
Interval 9.6 to 16.8
|
13.1 percentage of subjects
Interval 9.8 to 17.0
|
18.1 percentage of subjects
Interval 14.2 to 22.4
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 40
|
17.0 percentage of subjects
Interval 13.3 to 21.3
|
16.7 percentage of subjects
Interval 13.0 to 20.9
|
22.5 percentage of subjects
Interval 18.3 to 27.2
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 44
|
16.2 percentage of subjects
Interval 12.5 to 20.4
|
13.9 percentage of subjects
Interval 10.5 to 17.9
|
18.1 percentage of subjects
Interval 14.2 to 22.4
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 48
|
16.5 percentage of subjects
Interval 12.8 to 20.7
|
13.6 percentage of subjects
Interval 10.2 to 17.6
|
21.4 percentage of subjects
Interval 17.3 to 26.0
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 52
|
12.8 percentage of subjects
Interval 9.6 to 16.8
|
12.8 percentage of subjects
Interval 9.5 to 16.7
|
13.9 percentage of subjects
Interval 10.5 to 17.9
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 56
|
15.6 percentage of subjects
Interval 12.0 to 19.8
|
15.0 percentage of subjects
Interval 11.5 to 19.1
|
20.6 percentage of subjects
Interval 16.5 to 25.1
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 60
|
12.6 percentage of subjects
Interval 9.3 to 16.5
|
13.1 percentage of subjects
Interval 9.8 to 17.0
|
15.3 percentage of subjects
Interval 11.7 to 19.4
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 64
|
14.2 percentage of subjects
Interval 10.8 to 18.3
|
13.3 percentage of subjects
Interval 10.0 to 17.3
|
20.0 percentage of subjects
Interval 16.0 to 24.5
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 68
|
13.7 percentage of subjects
Interval 10.3 to 17.7
|
14.2 percentage of subjects
Interval 10.7 to 18.2
|
15.3 percentage of subjects
Interval 11.7 to 19.4
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 72
|
11.7 percentage of subjects
Interval 8.6 to 15.5
|
10.8 percentage of subjects
Interval 7.8 to 14.5
|
17.8 percentage of subjects
Interval 14.0 to 22.1
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 76
|
12.0 percentage of subjects
Interval 8.8 to 15.8
|
12.5 percentage of subjects
Interval 9.3 to 16.4
|
13.3 percentage of subjects
Interval 10.0 to 17.3
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 80
|
11.7 percentage of subjects
Interval 8.6 to 15.5
|
12.8 percentage of subjects
Interval 9.5 to 16.7
|
15.8 percentage of subjects
Interval 12.2 to 20.0
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 84
|
11.5 percentage of subjects
Interval 8.3 to 15.2
|
11.7 percentage of subjects
Interval 8.5 to 15.4
|
16.7 percentage of subjects
Interval 13.0 to 20.9
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 88
|
14.5 percentage of subjects
Interval 11.0 to 18.6
|
11.4 percentage of subjects
Interval 8.3 to 15.1
|
17.2 percentage of subjects
Interval 13.5 to 21.5
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 92
|
12.6 percentage of subjects
Interval 9.3 to 16.5
|
10.3 percentage of subjects
Interval 7.3 to 13.9
|
13.1 percentage of subjects
Interval 9.8 to 17.0
|
|
Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye
Week 96
|
13.7 percentage of subjects
Interval 10.3 to 17.7
|
11.1 percentage of subjects
Interval 8.1 to 14.8
|
14.4 percentage of subjects
Interval 11.0 to 18.5
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96Population: FAS - LOCF
Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 4
|
47.8 percentage of subjects
Interval 42.5 to 53.1
|
47.2 percentage of subjects
Interval 42.0 to 52.5
|
54.7 percentage of subjects
Interval 49.4 to 59.9
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 8
|
32.7 percentage of subjects
Interval 27.8 to 37.8
|
30.3 percentage of subjects
Interval 25.6 to 35.3
|
42.5 percentage of subjects
Interval 37.3 to 47.8
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 12
|
26.0 percentage of subjects
Interval 21.5 to 30.8
|
24.2 percentage of subjects
Interval 19.8 to 28.9
|
34.4 percentage of subjects
Interval 29.5 to 39.6
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 16
|
41.6 percentage of subjects
Interval 36.5 to 46.9
|
33.9 percentage of subjects
Interval 29.0 to 39.0
|
52.2 percentage of subjects
Interval 46.9 to 57.5
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 20
|
45.3 percentage of subjects
Interval 40.0 to 50.6
|
44.4 percentage of subjects
Interval 39.2 to 49.7
|
33.3 percentage of subjects
Interval 28.5 to 38.5
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 24
|
39.9 percentage of subjects
Interval 34.8 to 45.2
|
27.5 percentage of subjects
Interval 23.0 to 32.4
|
50.8 percentage of subjects
Interval 45.5 to 56.1
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 28
|
36.9 percentage of subjects
Interval 31.9 to 42.1
|
31.4 percentage of subjects
Interval 26.6 to 36.5
|
35.3 percentage of subjects
Interval 30.3 to 40.5
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 32
|
45.5 percentage of subjects
Interval 40.3 to 50.8
|
40.0 percentage of subjects
Interval 34.9 to 45.3
|
50.3 percentage of subjects
Interval 45.0 to 55.6
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 36
|
28.8 percentage of subjects
Interval 24.1 to 33.8
|
25.6 percentage of subjects
Interval 21.1 to 30.4
|
34.7 percentage of subjects
Interval 29.8 to 39.9
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 40
|
37.2 percentage of subjects
Interval 32.1 to 42.4
|
32.5 percentage of subjects
Interval 27.7 to 37.6
|
45.6 percentage of subjects
Interval 40.3 to 50.9
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 44
|
38.3 percentage of subjects
Interval 33.2 to 43.5
|
32.2 percentage of subjects
Interval 27.4 to 37.3
|
32.2 percentage of subjects
Interval 27.4 to 37.3
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 48
|
34.1 percentage of subjects
Interval 29.2 to 39.2
|
31.1 percentage of subjects
Interval 26.4 to 36.2
|
44.7 percentage of subjects
Interval 39.5 to 50.0
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 52
|
30.7 percentage of subjects
Interval 26.0 to 35.8
|
24.7 percentage of subjects
Interval 20.4 to 29.5
|
29.7 percentage of subjects
Interval 25.0 to 34.7
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 56
|
38.8 percentage of subjects
Interval 33.7 to 44.1
|
35.0 percentage of subjects
Interval 30.1 to 40.2
|
41.9 percentage of subjects
Interval 36.8 to 47.2
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 60
|
27.1 percentage of subjects
Interval 22.6 to 32.0
|
23.6 percentage of subjects
Interval 19.3 to 28.3
|
30.8 percentage of subjects
Interval 26.1 to 35.9
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 64
|
33.5 percentage of subjects
Interval 28.6 to 38.7
|
28.9 percentage of subjects
Interval 24.3 to 33.9
|
41.1 percentage of subjects
Interval 36.0 to 46.4
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 68
|
34.1 percentage of subjects
Interval 29.2 to 39.2
|
29.2 percentage of subjects
Interval 24.5 to 34.2
|
26.9 percentage of subjects
Interval 22.4 to 31.8
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 72
|
27.9 percentage of subjects
Interval 23.3 to 32.9
|
24.4 percentage of subjects
Interval 20.1 to 29.2
|
36.9 percentage of subjects
Interval 31.9 to 42.2
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 76
|
28.8 percentage of subjects
Interval 24.1 to 33.8
|
25.3 percentage of subjects
Interval 20.9 to 30.1
|
28.6 percentage of subjects
Interval 24.0 to 33.6
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 80
|
32.1 percentage of subjects
Interval 27.3 to 37.2
|
28.6 percentage of subjects
Interval 24.0 to 33.6
|
36.7 percentage of subjects
Interval 31.7 to 41.9
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 84
|
26.3 percentage of subjects
Interval 21.8 to 31.1
|
23.9 percentage of subjects
Interval 19.6 to 28.6
|
28.3 percentage of subjects
Interval 23.7 to 33.3
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 88
|
32.7 percentage of subjects
Interval 27.8 to 37.8
|
26.1 percentage of subjects
Interval 21.6 to 31.0
|
36.7 percentage of subjects
Interval 31.7 to 41.9
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 92
|
29.9 percentage of subjects
Interval 25.2 to 34.9
|
22.8 percentage of subjects
Interval 18.5 to 27.5
|
25.8 percentage of subjects
Interval 21.4 to 30.7
|
|
Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye
Week 96
|
30.4 percentage of subjects
Interval 25.7 to 35.5
|
23.9 percentage of subjects
Interval 19.6 to 28.6
|
36.9 percentage of subjects
Interval 31.9 to 42.2
|
SECONDARY outcome
Timeframe: Weeks 36, 40, 44, 48Population: FAS - LOCF
Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. For each subject, the number of visits with SRF and/or IRF fluid is analyzed.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Number of Subjects With Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) Present Between Week 36 to Week 48, Reported by Number of Visits
0 Visits
|
154 subjects
|
171 subjects
|
153 subjects
|
|
Number of Subjects With Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) Present Between Week 36 to Week 48, Reported by Number of Visits
1 Visit
|
67 subjects
|
73 subjects
|
48 subjects
|
|
Number of Subjects With Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) Present Between Week 36 to Week 48, Reported by Number of Visits
2 Visits
|
47 subjects
|
39 subjects
|
39 subjects
|
|
Number of Subjects With Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) Present Between Week 36 to Week 48, Reported by Number of Visits
3 Visits
|
26 subjects
|
22 subjects
|
40 subjects
|
|
Number of Subjects With Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) Present Between Week 36 to Week 48, Reported by Number of Visits
4 Visits
|
64 subjects
|
55 subjects
|
60 subjects
|
SECONDARY outcome
Timeframe: Week 16Population: FAS - 'efficacy/safety' approach. Censored data attributable to lack of efficacy and/or safety are imputed with q8w need = Yes at the next disease activity assessment visit.
A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% CI for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=353 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=346 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=344 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With Disease Activity Present (q8 Treatment Need = "Yes") at Week 16 - Study Eye
|
28.0 percentage of subjects
Interval 23.4 to 33.0
|
24.0 percentage of subjects
Interval 19.6 to 28.8
|
34.6 percentage of subjects
Interval 29.6 to 39.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96Population: FAS - Observed. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.
The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from age-related macular degeneration (AMD) subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96
Change from baseline at Week 24
|
4.4 score on a scale
Standard Deviation 10.49
|
4.0 score on a scale
Standard Deviation 12.20
|
3.5 score on a scale
Standard Deviation 9.97
|
|
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96
Change from baseline at Week 48
|
4.3 score on a scale
Standard Deviation 11.44
|
4.1 score on a scale
Standard Deviation 12.58
|
4.5 score on a scale
Standard Deviation 10.64
|
|
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96
Change from baseline at Week 72
|
4.4 score on a scale
Standard Deviation 12.19
|
3.9 score on a scale
Standard Deviation 12.53
|
4.0 score on a scale
Standard Deviation 12.05
|
|
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96
Change from baseline at Week 96
|
3.8 score on a scale
Standard Deviation 13.53
|
3.8 score on a scale
Standard Deviation 13.50
|
2.8 score on a scale
Standard Deviation 13.28
|
SECONDARY outcome
Timeframe: Week 48Population: Safety Analysis Set - Observed. All randomized subjects who received at least 1 intravitreal injection.
Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point. Hypothesis testing not pre-specified.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=356 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=353 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=348 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only)
|
25.6 percentage of subjects
|
20.4 percentage of subjects
|
65.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 48, 96Population: FAS with non-missing values. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.
Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
Week 12
|
0.0 percentage of subjects
|
0.3 percentage of subjects
|
0.9 percentage of subjects
|
|
Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
Week 48
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
Week 96
|
0.3 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 48, 96Population: FAS with non-missing values. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.
Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.
Outcome measures
| Measure |
Brolucizumab 3 mg
n=358 Participants
Single intravitreal (IVT) injection of brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose at Day 0, Week 4, and Week 8, followed by 1 injection every 8 weeks/1 injection every 12 weeks (q8w/q12w) maintenance regimen until study exit
|
Brolucizumab 6 mg
n=360 Participants
Single IVT injection of brolucizumab ophthalmic solution administered as a 6 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w/q12w maintenance regimen until study exit
|
Aflibercept 2 mg
n=360 Participants
Single IVT injection of aflibercept ophthalmic solution administered as a 2 mg/50 μL dose at Day 0, Week 4, and Week 8, followed by q8w maintenance regimen until study exit
|
|---|---|---|---|
|
Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
Week 12
|
1.6 percentage of subjects
|
2.4 percentage of subjects
|
0.7 percentage of subjects
|
|
Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
Week 48
|
1.8 percentage of subjects
|
0.4 percentage of subjects
|
2.6 percentage of subjects
|
|
Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye
Week 96
|
0.7 percentage of subjects
|
0.8 percentage of subjects
|
1.6 percentage of subjects
|
Adverse Events
Brolucizumab 3mg
Serious events: 94 serious events
Other events: 239 other events
Deaths: 9 deaths
Brolucizumab 6mg
Serious events: 95 serious events
Other events: 228 other events
Deaths: 8 deaths
Aflibercept 2mg
Serious events: 114 serious events
Other events: 228 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Brolucizumab 3mg
n=358 participants at risk
All subjects exposed to brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose
|
Brolucizumab 6mg
n=360 participants at risk
All subjects exposed to brolucizumab ophthalmic solution administered as a 6 mg/50 microliter (μL) dose
|
Aflibercept 2mg
n=360 participants at risk
All subjects exposed to aflibercept ophthalmic solution administered as a 2 mg/50 μL dose
|
|---|---|---|---|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Aortic valve incompetence
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
4/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
1.1%
4/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Cardiac arrest
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Cardiac failure
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
4/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
1.7%
6/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
1.1%
4/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Cardiogenic shock
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Coronary artery disease
|
1.7%
6/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.83%
3/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Left ventricular failure
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.83%
3/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Pericardial effusion
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Congenital, familial and genetic disorders
Endocardial fibroelastosis
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Cataract - Fellow eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Cataract - Study eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Cataract subcapsular - Study eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Glaucoma - Study eye
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Macular hole - Study eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Neovascular age-related macular degeneration - Fellow eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Retinal artery occlusion - Study eye
|
0.84%
3/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Retinal artery thrombosis - Study eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Retinal depigmentation - Study eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Retinal detachment - Study eye
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Retinal haemorrhage - Fellow eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Retinopathy proliferative - Study eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Uveitis - Study eye
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Visual acuity reduced - Study eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Vitritis - Study eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.83%
3/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Nausea
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Gastrointestinal disorders
Vomiting
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
General disorders
Asthenia
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
General disorders
Chest pain
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
General disorders
Death
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
General disorders
Mass
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
General disorders
Non-cardiac chest pain
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.83%
3/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
General disorders
Pyrexia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Hepatobiliary disorders
Cholangitis
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.1%
4/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Abscess oral
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Appendicitis
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Bronchitis
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Device related infection
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Endophthalmitis - Study eye
|
0.84%
3/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.83%
3/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Influenza
|
0.84%
3/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Kidney infection
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Perineal cellulitis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Pneumonia
|
2.0%
7/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
2.8%
10/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
2.5%
9/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Pyelonephritis
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Sepsis
|
0.84%
3/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
1.1%
4/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Septic shock
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.83%
3/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Urinary tract infection
|
1.1%
4/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Facial bones fracture - Fellow eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
1.1%
4/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.83%
3/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Investigations
Blood parathyroid hormone increased
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Investigations
Blood pressure increased
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Investigations
Platelet count decreased
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
4/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma recurrent
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the hypopharynx
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Carotid artery occlusion
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Cerebral infarction
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.84%
3/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
1.1%
4/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.83%
3/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Dementia
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Headache
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Intracranial aneurysm
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Seizure
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Syncope
|
0.84%
3/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.83%
3/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.84%
3/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Nervous system disorders
VIth nerve paralysis - Fellow eye
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Product Issues
Device dislocation
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Product Issues
Device failure
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Psychiatric disorders
Anxiety
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Psychiatric disorders
Delirium
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Psychiatric disorders
Major depression
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Psychiatric disorders
Mental status changes
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Psychiatric disorders
Schizophrenia
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Psychiatric disorders
Suicide attempt
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
1.7%
6/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
1.1%
4/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.56%
2/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Surgical and medical procedures
Hospitalisation
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Surgical and medical procedures
Mass excision
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.56%
2/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Embolism venous
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Haematoma
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Hypertension
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Hypertensive crisis
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Inferior vena caval occlusion
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Peripheral ischaemia
|
0.28%
1/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.28%
1/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
0.00%
0/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
Other adverse events
| Measure |
Brolucizumab 3mg
n=358 participants at risk
All subjects exposed to brolucizumab ophthalmic solution administered as a 3 mg/50 microliter (μL) dose
|
Brolucizumab 6mg
n=360 participants at risk
All subjects exposed to brolucizumab ophthalmic solution administered as a 6 mg/50 microliter (μL) dose
|
Aflibercept 2mg
n=360 participants at risk
All subjects exposed to aflibercept ophthalmic solution administered as a 2 mg/50 μL dose
|
|---|---|---|---|
|
Eye disorders
Cataract - Study eye
|
5.0%
18/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.3%
19/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
3.6%
13/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Conjunctival haemorrhage - Study eye
|
10.9%
39/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
8.1%
29/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
8.9%
32/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Dry eye - Fellow eye
|
4.5%
16/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
4.2%
15/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
6.7%
24/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Dry eye - Study eye
|
5.6%
20/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.3%
19/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
7.2%
26/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Eye pain - Study eye
|
7.8%
28/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.0%
18/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.8%
21/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Neovascular age-related macular degeneration - Fellow eye
|
9.2%
33/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
8.9%
32/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
8.6%
31/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Retinal haemorrhage - Study eye
|
3.9%
14/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.8%
21/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.6%
20/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Visual acuity reduced - Study eye
|
9.5%
34/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.8%
21/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
7.5%
27/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Vitreous detachment - Study eye
|
6.7%
24/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.3%
19/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.3%
19/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Eye disorders
Vitreous floaters - Study eye
|
7.3%
26/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
6.1%
22/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
4.4%
16/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Bronchitis
|
3.4%
12/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
3.6%
13/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.8%
21/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Influenza
|
4.2%
15/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
4.7%
17/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.6%
20/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Nasopharyngitis
|
12.3%
44/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
10.6%
38/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
12.2%
44/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Pneumonia
|
2.8%
10/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
6.4%
23/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
3.6%
13/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Infections and infestations
Urinary tract infection
|
10.9%
39/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
7.2%
26/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
11.1%
40/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
18/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
2.2%
8/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
1.9%
7/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
19/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
4.2%
15/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
5.8%
21/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
26/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
3.6%
13/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
4.7%
17/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
20/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
3.6%
13/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
4.7%
17/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
|
Vascular disorders
Hypertension
|
9.2%
33/358 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
6.9%
25/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
6.4%
23/360 • First treatment through study completion, an average of 96 weeks
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects who received at least 1 IVT injection (Safety Analysis Set).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER