Trial Outcomes & Findings for Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration (NCT NCT04522167)
NCT ID: NCT04522167
Last Updated: 2025-11-13
Results Overview
Changes in Best Corrected Visual Acuity (BCVA) by ETDRS letters from the Baseline Visit (Visit 1) to Week 8 (Visit 3) were assessed. This involved measuring the number of letters a participant could correctly read using the study eye on the ETDRS chart. An increase in the number of ETDRS letters from baseline signifies an improvement in visual acuity of the study eye. The change from baseline was calculated as the observed post-baseline value minus the baseline value.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
434 participants
Primary outcome timeframe
Week 8
Results posted on
2025-11-13
Participant Flow
Only 1 eye was selected from each patient as the study eye. Patients with signs of nAMD in the fellow eye likely to require IVT anti-VEGF treatment during the study were excluded. Any necessary treatment for wAMD in the fellow eye was prohibited for the first eight weeks and could only occur with Eylea at least 14 days after study eye treatment, without classifying the fellow eye as a study eye.
Participant milestones
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Overall Study
STARTED
|
215
|
219
|
|
Overall Study
COMPLETED
|
196
|
206
|
|
Overall Study
NOT COMPLETED
|
19
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With Neovascular Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=215 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=218 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Total
n=433 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.7 years
STANDARD_DEVIATION 7.72 • n=10 Participants
|
73.3 years
STANDARD_DEVIATION 7.70 • n=10 Participants
|
73.5 years
STANDARD_DEVIATION 7.71 • n=20 Participants
|
|
Age, Customized
Age, Categorical · Between 18 and 64 years
|
17 Participants
n=10 Participants
|
25 Participants
n=10 Participants
|
42 Participants
n=20 Participants
|
|
Age, Customized
Age, Categorical · Between 65 and 84 years
|
181 Participants
n=10 Participants
|
180 Participants
n=10 Participants
|
361 Participants
n=20 Participants
|
|
Age, Customized
Age, Categorical · >= 85 years
|
17 Participants
n=10 Participants
|
13 Participants
n=10 Participants
|
30 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=10 Participants
|
127 Participants
n=10 Participants
|
248 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=10 Participants
|
91 Participants
n=10 Participants
|
185 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
212 Participants
n=10 Participants
|
213 Participants
n=10 Participants
|
425 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=10 Participants
|
16 Participants
n=10 Participants
|
33 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
197 Participants
n=10 Participants
|
201 Participants
n=10 Participants
|
398 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
Bulgaria
|
10 participants
n=10 Participants
|
11 participants
n=10 Participants
|
21 participants
n=20 Participants
|
|
Region of Enrollment
Czechia
|
34 participants
n=10 Participants
|
35 participants
n=10 Participants
|
69 participants
n=20 Participants
|
|
Region of Enrollment
Hungary
|
34 participants
n=10 Participants
|
34 participants
n=10 Participants
|
68 participants
n=20 Participants
|
|
Region of Enrollment
Israel
|
6 participants
n=10 Participants
|
6 participants
n=10 Participants
|
12 participants
n=20 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=10 Participants
|
9 participants
n=10 Participants
|
18 participants
n=20 Participants
|
|
Region of Enrollment
Japan
|
17 participants
n=10 Participants
|
16 participants
n=10 Participants
|
33 participants
n=20 Participants
|
|
Region of Enrollment
Poland
|
37 participants
n=10 Participants
|
40 participants
n=10 Participants
|
77 participants
n=20 Participants
|
|
Region of Enrollment
Russia
|
35 participants
n=10 Participants
|
36 participants
n=10 Participants
|
71 participants
n=20 Participants
|
|
Region of Enrollment
Ukraine
|
33 participants
n=10 Participants
|
31 participants
n=10 Participants
|
64 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Full Analysis Set (FAS)
Changes in Best Corrected Visual Acuity (BCVA) by ETDRS letters from the Baseline Visit (Visit 1) to Week 8 (Visit 3) were assessed. This involved measuring the number of letters a participant could correctly read using the study eye on the ETDRS chart. An increase in the number of ETDRS letters from baseline signifies an improvement in visual acuity of the study eye. The change from baseline was calculated as the observed post-baseline value minus the baseline value.
Outcome measures
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=215 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=218 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at Week 8 of Treatment With FYB203 or Eylea Compared to Baseline.
|
6.6 letters
Standard Error 0.73
|
5.6 letters
Standard Error 0.73
|
SECONDARY outcome
Timeframe: Through study completion, until Week 56 (Visit 9)Population: FAS = Full Analysis Set
Change of BCVA by ETDRS letters over the whole study from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS
Outcome measures
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=215 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=218 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Evaluate and Compare Functional Changes of the Retina by BCVA Over Time
to Week 24 (Visit 5)
|
7.0 letters
Standard Deviation 9.45
|
6.6 letters
Standard Deviation 9.51
|
|
Evaluate and Compare Functional Changes of the Retina by BCVA Over Time
to Week 56 (Visit 9)
|
8.3 letters
Standard Deviation 10.37
|
6.6 letters
Standard Deviation 11.47
|
SECONDARY outcome
Timeframe: Through study completion, until Week 56 (Visit 9)Population: FAS = Full Analysis Set
Change from Baseline Visit (Visit 1) in foveal center point FCP retinal thickness to Week 4 (Visit 2), Week 24 (Visit 5) and Week 56 (Visit 9) - FAS
Outcome measures
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=215 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=218 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness
to Week 4 (Visit 2)
|
-163.9 μm
Standard Deviation 142.17
|
-168.4 μm
Standard Deviation 126.36
|
|
Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness
to Week 24 (Visit 5)
|
-165.9 μm
Standard Deviation 174.98
|
-172.4 μm
Standard Deviation 153.00
|
|
Evaluate and Compare Changes in Foveal Center Point (FCP) Retinal Thickness
to Week 56 (Visit 9)
|
-188.4 μm
Standard Deviation 181.08
|
-202.4 μm
Standard Deviation 156.96
|
SECONDARY outcome
Timeframe: Through study completion, until Week 56 (Week 9)Population: FAS = Full Analysis Set
Proportion of patients who gain or lose ≥ 5, 10, or 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters from Baseline Visit (Visit 1) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS
Outcome measures
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=215 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=218 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 24 (Visit 5) · ≥ 5 and < 10 letters (gain 5-9)
|
41 Participants
|
47 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 24 (Visit 5) · > -5 and < 5 letters (gain or loss up to 4)
|
52 Participants
|
58 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 24 (Visit 5) · > -10 and ≤ -5 letters (loss 5-9)
|
12 Participants
|
13 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 24 (Visit 5) · > -15 and ≤ -10 letters (loss 10-14)
|
6 Participants
|
2 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 24 (Visit 5) · ≤ -15 letters (loss 15 or more)
|
4 Participants
|
6 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 56 (Visit 9) · ≥ 15 letters (gain 15 or more)
|
52 Participants
|
49 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 56 (Visit 9) · ≥ 10 and < 15 letters (gain 10-14)
|
43 Participants
|
36 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 56 (Visit 9) · ≥ 5 and < 10 letters (gain 5-9)
|
34 Participants
|
39 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 56 (Visit 9) · > -5 and < 5 letters (gain or loss up to 4)
|
39 Participants
|
48 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 56 (Visit 9) · > -10 and ≤ -5 letters (loss 5-9)
|
12 Participants
|
13 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 56 (Visit 9) · > -15 and ≤ -10 letters (loss 10-14)
|
6 Participants
|
7 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 56 (Visit 9) · ≤ -15 letters (loss 15 or more)
|
2 Participants
|
9 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 24 (Visit 5) · ≥ 15 letters (gain 15 or more)
|
45 Participants
|
38 Participants
|
|
Evaluate and Compare the Proportion of Patients Who Gain or Lose ≥ 5, 10, and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters Compared to Baseline
to Week 24 (Visit 5) · ≥ 10 and < 15 letters (gain 10-14)
|
41 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Through study completion, until Week 56 (Visit 9)Population: FAS = Full Analysis Set
Percentage of patients with fluid-free macula at Baseline (Visit 1), Week 24 (Visit 5), Week 56 (Visit 9) - FAS
Outcome measures
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=215 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=218 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time
Baseline (Visit 1) · Assessment / Response = Yes
|
0 Participants
|
0 Participants
|
|
Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time
Baseline (Visit 1) · Assessment / Response = No
|
214 Participants
|
217 Participants
|
|
Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time
Week 24 (Visit 5) · Assessment / Response = Yes
|
71 Participants
|
65 Participants
|
|
Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time
Week 24 (Visit 5) · Assessment / Response = No
|
127 Participants
|
135 Participants
|
|
Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time
Week 56 (Visit 9) · Assessment / Response = Yes
|
79 Participants
|
100 Participants
|
|
Evaluate and Compare the Absence of Disease Activity (Fluid-free Macula) Over Time
Week 56 (Visit 9) · Assessment / Response = No
|
108 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: At Baseline and Visit 3a (48 hours after the 3rd dose)Population: PKS = Plasma Concentration Analysis Set. Baseline values that were reported as \<LLOQ were analyzed with a numeric value of 0.5\*LLOQ.
Systemic concentrations (close to maximum concentration \[Cmax\]) of free aflibercept in a subgroup at selected sites - PKS: \- 48 hours after the 3rd dose (Visit 3a)
Outcome measures
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=31 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=26 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm)
Baseline (Visit 1)
|
2.000 ng/mL
Standard Deviation 0.0000
|
2.000 ng/mL
Standard Deviation 0.0000
|
|
Evaluate and Compare Systemic Free Aflibercept Concentrations in a Subgroup of up to 60 Patients (up to 30 Per Arm)
Visit 3a (48h after 3rd dose)
|
122.166 ng/mL
Standard Deviation 30.5161
|
120.112 ng/mL
Standard Deviation 28.9556
|
SECONDARY outcome
Timeframe: Through study completion, until Week 56 (Visit 9)Population: FAS = Full Analysis Set
Change from Baseline Visit (Visit 1) in vision-related functioning and well-being measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) to Week 24 (Visit 5) and Week 56 (Visit 9) - FAS. The NEI VFQ-25 includes 12 subscales (e.g., general vision, ocular pain, driving, peripheral vision) scored from 0 to 100, where higher scores indicate better functioning. Subscales are averaged to produce a composite score, excluding the general health subscale. Both subscale and composite scores range from 0 (worst) to 100 (best), representing the percentage of the highest possible score achieved.
Outcome measures
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=215 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=218 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
to Week 24 (Visit 5)
|
3.8 score points
Standard Deviation 11.06
|
1.8 score points
Standard Deviation 10.97
|
|
Evaluate and Compare Change in Vision-related Functioning and Well-being Measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
to Week 56 (Visit 9)
|
3.8 score points
Standard Deviation 12.22
|
1.7 score points
Standard Deviation 12.46
|
SECONDARY outcome
Timeframe: Through study completion, until Week 56 (Visit 9)Population: SAF = Safety Analysis Set
Number of patients with anti-drug antibodies (ADAs) at Baseline (Visit 1), Week 24 (Visit 5) and Week 56 (Visit 9) - SAF
Outcome measures
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=215 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=218 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum
Week 1 (Baseline) · Positive
|
4 Participants
|
3 Participants
|
|
Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum
Week 1 (Baseline) · Negative
|
209 Participants
|
201 Participants
|
|
Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum
Week 24 (Visit 5) · Positive
|
4 Participants
|
1 Participants
|
|
Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum
Week 24 (Visit 5) · Negative
|
191 Participants
|
192 Participants
|
|
Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum
Week 56 (Visit 9) · Positive
|
5 Participants
|
2 Participants
|
|
Evaluate and Compare the Immunogenic Profile (Anti-drug Antibodies [ADAs]) in Serum
Week 56 (Visit 9) · Negative
|
189 Participants
|
190 Participants
|
SECONDARY outcome
Timeframe: Through study completion, until Week 56 (Visit 9)Population: SAF = Safety Analysis Set
Frequency of local and systemic adverse events (AEs) and serious adverse events (SAEs) - SAF
Outcome measures
| Measure |
FYB203 (Proposed Aflibercept Biosimilar)
n=215 Participants
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
Eylea® (Aflibercept)
n=218 Participants
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
|
|---|---|---|
|
Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)
local AEs, study eye
|
67 Participants
|
75 Participants
|
|
Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)
local AEs, fellow eye
|
45 Participants
|
48 Participants
|
|
Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)
systemic AEs
|
124 Participants
|
113 Participants
|
|
Frequency of Local and Systemic Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
19 Participants
|
28 Participants
|
Adverse Events
FYB203 (Proposed Aflibercept Biosimilar), Systemic AE
Serious events: 17 serious events
Other events: 56 other events
Deaths: 4 deaths
Eylea® (Aflibercept), Systemic AE
Serious events: 23 serious events
Other events: 46 other events
Deaths: 1 deaths
FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Study Eye
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Eylea® (Aflibercept), Ocular AE, Study Eye
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Fellow Eye
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Eylea® (Aflibercept), Ocular AE, Fellow Eye
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FYB203 (Proposed Aflibercept Biosimilar), Systemic AE
n=215 participants at risk
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
In this column all systemic AEs by patient for the FYB203 group are given.
|
Eylea® (Aflibercept), Systemic AE
n=218 participants at risk
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
In this column all systemic AEs by patient for the Eylea® group are given.
|
FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Study Eye
n=215 participants at risk
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
In this column all ocular AEs by patient for the FYB203 group occurring in the study eye are given.
|
Eylea® (Aflibercept), Ocular AE, Study Eye
n=218 participants at risk
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
In this column all ocular AEs by patient for the Eylea® group occurring in the study eye are given.
|
FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Fellow Eye
n=215 participants at risk
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
The fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 19 patients choose to get treatment for the fellow eye (from 1 to 6 injections).
In this column all ocular AEs by patient for the FYB203 group occurring in the fellow eye are given.
|
Eylea® (Aflibercept), Ocular AE, Fellow Eye
n=218 participants at risk
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
The fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 20 patients choose to get treatment for the fellow eye (from 1 to 6 injections).
In this column all ocular AEs by patient for the Eylea® group occurring in the fellow eye are given.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
1.9%
4/215 • Number of events 4 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.92%
2/218 • Number of events 2 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.92%
2/218 • Number of events 2 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Pneumonia
|
0.47%
1/215 • Number of events 3 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Bronchitis
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Coronavirus infection
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Gallbladder empyema
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Toxic shock syndrome
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Urosepsis
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 2 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma stage 0
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.93%
2/215 • Number of events 2 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Glaucoma
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Uveitis
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Nervous system disorders
Dementia
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Injury, poisoning and procedural complications
Nerve root injury
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
Other adverse events
| Measure |
FYB203 (Proposed Aflibercept Biosimilar), Systemic AE
n=215 participants at risk
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
In this column all systemic AEs by patient for the FYB203 group are given.
|
Eylea® (Aflibercept), Systemic AE
n=218 participants at risk
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
In this column all systemic AEs by patient for the Eylea® group are given.
|
FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Study Eye
n=215 participants at risk
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
In this column all ocular AEs by patient for the FYB203 group occurring in the study eye are given.
|
Eylea® (Aflibercept), Ocular AE, Study Eye
n=218 participants at risk
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
In this column all ocular AEs by patient for the Eylea® group occurring in the study eye are given.
|
FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Fellow Eye
n=215 participants at risk
Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol.
FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
The fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 19 patients choose to get treatment for the fellow eye (from 1 to 6 injections).
In this column all ocular AEs by patient for the FYB203 group occurring in the fellow eye are given.
|
Eylea® (Aflibercept), Ocular AE, Fellow Eye
n=218 participants at risk
Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol.
Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
The fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 20 patients choose to get treatment for the fellow eye (from 1 to 6 injections).
In this column all ocular AEs by patient for the Eylea® group occurring in the fellow eye are given.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
3.3%
7/215 • Number of events 9 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
3.2%
7/218 • Number of events 9 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
10.2%
22/215 • Number of events 22 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
11.0%
24/218 • Number of events 25 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Cataract
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
3.7%
8/215 • Number of events 9 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
3.2%
7/218 • Number of events 7 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
3.3%
7/215 • Number of events 7 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
1.8%
4/218 • Number of events 4 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
1.9%
4/215 • Number of events 4 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
6.4%
14/218 • Number of events 24 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.47%
1/215 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
3.3%
7/215 • Number of events 7 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
1.8%
4/218 • Number of events 4 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.93%
2/215 • Number of events 2 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.92%
2/218 • Number of events 2 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Eye pain
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
2.8%
6/215 • Number of events 6 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
2.8%
6/218 • Number of events 9 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
2.8%
6/215 • Number of events 6 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
1.4%
3/218 • Number of events 3 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
COVID-19
|
7.0%
15/215 • Number of events 17 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
7.8%
17/218 • Number of events 17 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
10/215 • Number of events 11 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
2.8%
6/218 • Number of events 6 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
2.3%
5/215 • Number of events 6 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
2.8%
6/218 • Number of events 6 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
2.3%
5/215 • Number of events 5 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Infections and infestations
Coronavirus infection
|
2.3%
5/215 • Number of events 5 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
5/215 • Number of events 5 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
2.8%
6/218 • Number of events 6 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.2%
9/215 • Number of events 10 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
3.3%
7/215 • Number of events 9 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
4.1%
9/218 • Number of events 25 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.93%
2/215 • Number of events 2 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.46%
1/218 • Number of events 1 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Vascular disorders
Hypertension
|
7.0%
15/215 • Number of events 16 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
4.1%
9/218 • Number of events 12 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
|
Nervous system disorders
Headache
|
1.9%
4/215 • Number of events 4 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
3.2%
7/218 • Number of events 12 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/215 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
0.00%
0/218 • All AEs reported until the final end of study visit at week 56 are included.
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place