Trial Outcomes & Findings for Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema (NCT NCT04739306)
NCT ID: NCT04739306
Last Updated: 2023-12-05
Results Overview
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Subjects with a BCVA ETDRS letter score of 73 to 34 (= Acuity of 20/40 to 20/200) in the study eye at Screening and Day 1 were included. Visual acuity of the study eye was assessed using the ETDRS charts; a higher score represents better functioning.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
348 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2023-12-05
Participant Flow
Subjects who were randomly assigned to either group administrated study drug by intravitreal injection (IVT) via a sigle-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48. After the Main Study period, a total of 31 subjects, regardless of the treatment group in Main Study Period, were enrolled in a 4-week open-label, single-arm Extension study. The subjects were administrated 2 mg/0.05mL of CT-P42 by pre-filled syringe IVT injection at Extension Week 0 (1 dose).
Participant milestones
| Measure |
CT-P42 (Main Study Period)
Subjects who were randomly assigned to CT-P42 group (2mg/0.05 mL) administrated by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
Eylea (Main Study Period)
Subjects who were randomly assigned to Eylea group (2mg/0.05 mL) administrated by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
|---|---|---|
|
Main Study Period
STARTED
|
173
|
175
|
|
Main Study Period
COMPLETED
|
153
|
153
|
|
Main Study Period
NOT COMPLETED
|
20
|
22
|
|
CT-P42 PFS (Extension Study Period)
STARTED
|
15
|
16
|
|
CT-P42 PFS (Extension Study Period)
COMPLETED
|
15
|
16
|
|
CT-P42 PFS (Extension Study Period)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
CT-P42 (Main Study Period)
Subjects who were randomly assigned to CT-P42 group (2mg/0.05 mL) administrated by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
Eylea (Main Study Period)
Subjects who were randomly assigned to Eylea group (2mg/0.05 mL) administrated by intravitreal injection via a single-dose vial every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
|---|---|---|
|
Main Study Period
Adverse Event
|
6
|
7
|
|
Main Study Period
Lost to Follow-up
|
4
|
6
|
|
Main Study Period
Physician Decision
|
1
|
1
|
|
Main Study Period
Withdrawal by Subject
|
8
|
6
|
|
Main Study Period
Protocol Violation
|
0
|
1
|
|
Main Study Period
War in Ukraine
|
1
|
1
|
Baseline Characteristics
Study to Compare Efficacy and Safety of CT-P42 in Comparison With Eylea in Patients With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
CT-P42
n=173 Participants
CT-P42: 2mg/0.05 mL by Intravitreal injection
|
Eylea
n=175 Participants
Eylea: 2mg/0.05 mL by Intravitreal injection
|
Total
n=348 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
62.9 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
62.7 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
166 Participants
n=99 Participants
|
165 Participants
n=107 Participants
|
331 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
61 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
112 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
224 Participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
19 participants
n=99 Participants
|
18 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Region of Enrollment
Estonia
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Hungary
|
21 participants
n=99 Participants
|
20 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Region of Enrollment
India
|
51 participants
n=99 Participants
|
53 participants
n=107 Participants
|
104 participants
n=206 Participants
|
|
Region of Enrollment
Latvia
|
9 participants
n=99 Participants
|
5 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
Lithuania
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
19 participants
n=99 Participants
|
21 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
Slovakia
|
24 participants
n=99 Participants
|
23 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
BCVA score at Baseline
|
60.3 letters
STANDARD_DEVIATION 9.7 • n=99 Participants
|
60.4 letters
STANDARD_DEVIATION 10.1 • n=107 Participants
|
60.4 letters
STANDARD_DEVIATION 9.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Full analysis set (FAS) consists of all subjects who are randomly assigned and received at least 1 full dose of study drug during the Main Study Period. Missing data were not imputed unless methods for handling missing data are specified.
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8. Subjects with a BCVA ETDRS letter score of 73 to 34 (= Acuity of 20/40 to 20/200) in the study eye at Screening and Day 1 were included. Visual acuity of the study eye was assessed using the ETDRS charts; a higher score represents better functioning.
Outcome measures
| Measure |
CT-P42
n=169 Participants
Subjects received Intravitreal injection of CT-P42 (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
Eylea
n=172 Participants
Subjects received Intravitreal injection of Eylea (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 8
|
9.43 letters
Standard Error 0.798
|
8.85 letters
Standard Error 0.775
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full analysis set (subjects analysed at Week 52). Missing data were not imputed unless methods for handling missing data are specified.
Mean change from baseline in BCVA as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 52.
Outcome measures
| Measure |
CT-P42
n=156 Participants
Subjects received Intravitreal injection of CT-P42 (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
Eylea
n=156 Participants
Subjects received Intravitreal injection of Eylea (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
|---|---|---|
|
Mean Change From Baseline in BCVA at Week 52
|
12.1 letters
Standard Deviation 8.9
|
11.1 letters
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full analysis set. Missing data were not imputed unless methods for handling missing data are specified.
Proportion of subjects who gained ≥15 letters from baseline in BCVA, assessed in change from baseline in ETDRS letters over time
Outcome measures
| Measure |
CT-P42
n=173 Participants
Subjects received Intravitreal injection of CT-P42 (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
Eylea
n=175 Participants
Subjects received Intravitreal injection of Eylea (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
|---|---|---|
|
Proportion of Subjects Who Gained ≥15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52
|
60 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full analysis set. Missing data were not imputed unless methods for handling missing data are specified.
The ETDRS DRSS score was grouped into 13 severity scores based on the ETDRS Severity Level. DR absent (level 10); Mild to moderate nonproliferative DR (levels 20, 35, and 43); Moderately severe/severe/Very Severe nonproliferative DR (levels 47, 53 and 53E); Inactive/Mild/moderate/high-risk/advanced proliferative DR (levels 60, 61, 65, 71,75, 81, and 85)
Outcome measures
| Measure |
CT-P42
n=173 Participants
Subjects received Intravitreal injection of CT-P42 (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
Eylea
n=175 Participants
Subjects received Intravitreal injection of Eylea (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
|---|---|---|
|
Proportion of Subjects With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52
|
41 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full analysis set (subjects analysed at Week 52). Missing data were not imputed unless methods for handling missing data are specified.
The mean change from baseline in Central Subfieldl Thickness as determined by Spectral domain- Optical coherence tomography (SD-OCT)
Outcome measures
| Measure |
CT-P42
n=151 Participants
Subjects received Intravitreal injection of CT-P42 (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
Eylea
n=154 Participants
Subjects received Intravitreal injection of Eylea (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
|---|---|---|
|
Change From Baseline in Central Subfield Thickness (CST) at Week 52 as Assessed on Optical Coherence Tomography (OCT)
|
-220.7 micrometer
Standard Deviation 147.1
|
-191.2 micrometer
Standard Deviation 137.0
|
Adverse Events
CT-P42 (Main Study Period)
Serious events: 19 serious events
Other events: 64 other events
Deaths: 3 deaths
Eylea (Main Study Period)
Serious events: 17 serious events
Other events: 71 other events
Deaths: 2 deaths
CT-P42 (Extension Study Period)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-P42 (Main Study Period)
n=174 participants at risk
Subjects received Intravitreal injection of CT-P42 (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
Eylea (Main Study Period)
n=174 participants at risk
Subjects received Intravitreal injection of Eylea (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
CT-P42 (Extension Study Period)
n=31 participants at risk
Subjects were administrated 2 mg/0.05mL of CT-P42 by intravitreal injection via a single-dose pre-filled syringe at Extension Week 0 (1 dose).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Deficiency anaemia
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Cardiac disorders
Cardiac arrest
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Cardiac disorders
Cardiac failure
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
1.1%
2/174 • Number of events 2 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Cardiac disorders
Myocardial infarction
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
General disorders
Death
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
1.1%
2/174 • Number of events 2 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
2/174 • Number of events 2 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
Device related infection
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
Diabetic gangrene
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
Emphysematous pyelonephritis
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
Gastroenteritis
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
Pneumonia
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Musculoskeletal and connective tissue disorders
Vertebral end plate inflammation
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
1.1%
2/174 • Number of events 2 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
1.1%
2/174 • Number of events 3 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Vascular disorders
Dry gangrene
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 2 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Vascular disorders
Vascular occlusion
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
Other adverse events
| Measure |
CT-P42 (Main Study Period)
n=174 participants at risk
Subjects received Intravitreal injection of CT-P42 (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
Eylea (Main Study Period)
n=174 participants at risk
Subjects received Intravitreal injection of Eylea (2mg/0.05 mL), every 4 weeks for 5 doses, then every 8 weeks for 4 doses up to Week 48.
|
CT-P42 (Extension Study Period)
n=31 participants at risk
Subjects were administrated 2 mg/0.05mL of CT-P42 by intravitreal injection via a single-dose pre-filled syringe at Extension Week 0 (1 dose).
|
|---|---|---|---|
|
Eye disorders
Cataract
|
3.4%
6/174 • Number of events 6 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
2.3%
4/174 • Number of events 4 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Eye disorders
Conjunctival haemorrhage
|
1.1%
2/174 • Number of events 2 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
2.3%
4/174 • Number of events 5 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Eye disorders
Diabetic retinal oedema
|
9.8%
17/174 • Number of events 18 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
13.2%
23/174 • Number of events 26 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
3.2%
1/31 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Eye disorders
Posterior capsule opacification
|
2.3%
4/174 • Number of events 5 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
1.7%
3/174 • Number of events 3 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Eye disorders
Visual acuity reduced
|
2.9%
5/174 • Number of events 5 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
2.3%
4/174 • Number of events 4 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Eye disorders
Vitreous floaters
|
1.7%
3/174 • Number of events 3 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
2.3%
4/174 • Number of events 4 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Eye disorders
Vitreous haemorrhage
|
2.3%
4/174 • Number of events 5 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
COVID-19
|
4.6%
8/174 • Number of events 8 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
5.7%
10/174 • Number of events 10 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
Influenza
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
3.4%
6/174 • Number of events 7 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
3.2%
1/31 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Infections and infestations
Nasopharyngitis
|
5.2%
9/174 • Number of events 11 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
2.3%
4/174 • Number of events 5 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
3.2%
1/31 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
3.2%
1/31 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
2.9%
5/174 • Number of events 5 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
3.2%
1/31 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Investigations
Intraocular pressure increased
|
1.7%
3/174 • Number of events 5 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
2.3%
4/174 • Number of events 8 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
4.0%
7/174 • Number of events 7 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
4.0%
7/174 • Number of events 7 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.57%
1/174 • Number of events 1 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
2.3%
4/174 • Number of events 4 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
4/174 • Number of events 4 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
2.9%
5/174 • Number of events 5 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
2.9%
5/174 • Number of events 5 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/174 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
|
Vascular disorders
Hypertension
|
6.3%
11/174 • Number of events 12 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
9.2%
16/174 • Number of events 17 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
0.00%
0/31 • Main Study Period: From Week 0 to 52 Weeks, Extension Study Period: On or After Extension Week 0, assessed up to 4 weeks
Safety analyses were performed in the safety population and was pre-specified to only report the most severe event if one or more events were occurred to the same subject. Note: One patient who was randomly assigned to the Eylea group was administered CT-P42 at the Week 40 visit. This patient grouped as CT-P42 group for the safety set for Main Study Period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER