Trial Outcomes & Findings for Efficacy and Safety of Three Different Aflibercept Regimens in Subjects With Diabetic Macular Edema (DME) (NCT NCT02818998)
NCT ID: NCT02818998
Last Updated: 2020-07-31
Results Overview
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
463 participants
Primary outcome timeframe
From baseline to Week 52
Results posted on
2020-07-31
Participant Flow
Study was conducted at multiple centers in 14 countries between 16-Nov-2016 (first participant first visit) and 24-Sep-2019 (last participant last visit).
A total of 500 participants were screened in this study. Of these, 37 participants did not enter the treatment period (31 were screening failures; 3 were lost to follow-up; 2 had an adverse event (AE) and 1 was not randomized due to an "other" reason). A total of 463 participants were randomized and received treatment.
Participant milestones
| Measure |
Aflibercept 2 mg Fixed
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Overall Study
STARTED
|
155
|
154
|
154
|
|
Overall Study
Completed Week 52 Visit
|
144
|
146
|
140
|
|
Overall Study
COMPLETED
|
137
|
138
|
136
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
18
|
Reasons for withdrawal
| Measure |
Aflibercept 2 mg Fixed
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
2
|
|
Overall Study
Withdrawal by sponsor
|
0
|
1
|
1
|
|
Overall Study
Death
|
3
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
6
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Three Different Aflibercept Regimens in Subjects With Diabetic Macular Edema (DME)
Baseline characteristics by cohort
| Measure |
Aflibercept 2 mg Fixed
n=155 Participants
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=154 Participants
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
n=154 Participants
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
Total
n=463 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.3 Years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
64.8 Years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
65.4 Years
STANDARD_DEVIATION 9.3 • n=206 Participants
|
64.8 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
178 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
100 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
285 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
428 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
141 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
432 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Best Corrected Visual Acuity (BCVA)
|
72.8 Scores on a scale
STANDARD_DEVIATION 10.38 • n=99 Participants
|
72.5 Scores on a scale
STANDARD_DEVIATION 11.35 • n=107 Participants
|
71.0 Scores on a scale
STANDARD_DEVIATION 10.87 • n=206 Participants
|
72.1 Scores on a scale
STANDARD_DEVIATION 10.88 • n=7 Participants
|
|
Central Retinal Thickness (CRT)
|
289.8 Microns
STANDARD_DEVIATION 66.46 • n=99 Participants
|
285.3 Microns
STANDARD_DEVIATION 76.01 • n=107 Participants
|
294.5 Microns
STANDARD_DEVIATION 80.72 • n=206 Participants
|
289.9 Microns
STANDARD_DEVIATION 74.55 • n=7 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 52Population: Full Analysis Set (FAS): included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.
Outcome measures
| Measure |
Aflibercept 2 mg Fixed
n=153 Participants
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=152 Participants
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
n=153 Participants
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52
|
0.4 Scores on a scale
Standard Deviation 6.7
|
0.5 Scores on a scale
Standard Deviation 6.7
|
1.7 Scores on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: From baseline to week 52Population: Participants in FAS taken into account for this analysis
Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Outcome measures
| Measure |
Aflibercept 2 mg Fixed
n=147 Participants
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=147 Participants
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
n=153 Participants
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Mean Change From Baseline in Central Retinal Thickness (CRT) at Week 52
|
-18.8 Microns
Standard Deviation 45.5
|
-2.1 Microns
Standard Deviation 56.2
|
2.2 Microns
Standard Deviation 77.8
|
SECONDARY outcome
Timeframe: From baseline to week 52Population: Full Analysis Set (FAS): included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Outcome measures
| Measure |
Aflibercept 2 mg Fixed
n=153 Participants
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=152 Participants
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
n=153 Participants
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52
≥15 letter gain
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52
≥10 letter gain
|
10 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52
≥30 letter loss
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 100Population: Full Analysis Set (FAS): included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.
Outcome measures
| Measure |
Aflibercept 2 mg Fixed
n=153 Participants
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=152 Participants
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
n=153 Participants
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 100
|
0.1 Scores on a scale
Standard Deviation 7.2
|
-0.1 Scores on a scale
Standard Deviation 9.1
|
1.8 Scores on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: From baseline to Week 100Population: Participants in FAS taken into account for this analysis
Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Outcome measures
| Measure |
Aflibercept 2 mg Fixed
n=147 Participants
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=147 Participants
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
n=153 Participants
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Mean Change From Baseline in Central Retinal Thickness (CRT) at Week 100
|
-15.5 Microns
Standard Deviation 64.3
|
2.3 Microns
Standard Deviation 81.8
|
-13.9 Microns
Standard Deviation 74.4
|
SECONDARY outcome
Timeframe: From baseline to Week 100Population: Full analysis set (FAS)
Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Outcome measures
| Measure |
Aflibercept 2 mg Fixed
n=153 Participants
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=152 Participants
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
n=153 Participants
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA) at Week 100
≥30 letter loss
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA) at Week 100
≥15 letter gain
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA) at Week 100
≥10 letter gain
|
10 Participants
|
17 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to Week 100Population: Safety analysis set (SAF): included all participants who received any study drug under the protocol.
AEs that started after the first application of aflibercept under this protocol until 30 days after the last dose of study drug administration
Outcome measures
| Measure |
Aflibercept 2 mg Fixed
n=155 Participants
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=154 Participants
Participants received flexible dosing of 2 mg aflibercept at injection intervals of ≥8 weeks
|
Aflibercept 2 mg PRN
n=154 Participants
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Event (TEAE)
|
129 Participants
|
128 Participants
|
129 Participants
|
Adverse Events
Aflibercept 2 mg Fixed
Serious events: 35 serious events
Other events: 97 other events
Deaths: 3 deaths
Aflibercept 2 mg Extended
Serious events: 38 serious events
Other events: 85 other events
Deaths: 6 deaths
Aflibercept 2 mg PRN
Serious events: 37 serious events
Other events: 98 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Aflibercept 2 mg Fixed
n=155 participants at risk
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=154 participants at risk
Participants received flexible dosing of 2 mg aflibercept at injection intervals of \>=8 week
|
Aflibercept 2 mg PRN
n=154 participants at risk
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 3 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Angina unstable
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.9%
3/154 • Number of events 3 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Cardiac failure
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Cardiogenic shock
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Coronary artery occlusion
|
1.3%
2/155 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
5/155 • Number of events 5 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.3%
2/155 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Ear and labyrinth disorders
Neurosensory hypoacusis
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Cataract
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.9%
3/154 • Number of events 4 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Cataract nuclear
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Cataract subcapsular
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Vitreous haemorrhage
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Choroidal neovascularisation
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Macular fibrosis
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
General disorders
Chest pain
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
General disorders
Death
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
General disorders
Fatigue
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
General disorders
Non-cardiac chest pain
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Cellulitis
|
1.3%
2/155 • Number of events 3 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Cystitis
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Erysipelas
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Gangrene
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Influenza
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Osteomyelitis
|
1.3%
2/155 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Pneumonia
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Postoperative wound infection
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Sepsis
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Wound infection
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Peritonsillitis
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Arthritis bacterial
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Biliary sepsis
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.65%
1/155 • Number of events 3 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Fall
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Investigations
Angiocardiogram
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.9%
3/155 • Number of events 3 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Cardiometabolic syndrome
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign spleen tumour
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Nervous system disorders
Lacunar stroke
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Skin and subcutaneous tissue disorders
Diabetic neuropathic ulcer
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.3%
2/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.9%
3/154 • Number of events 3 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Cardiac rehabilitation therapy
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Heart valve replacement
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Cataract operation
|
1.3%
2/155 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Vascular disorders
Aortic stenosis
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Vascular disorders
Hypertension
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Vascular disorders
Peripheral ischaemia
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.65%
1/155 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Vascular disorders
Arterial occlusive disease
|
0.65%
1/155 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Product Issues
Device loosening
|
0.00%
0/155 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
Other adverse events
| Measure |
Aflibercept 2 mg Fixed
n=155 participants at risk
Participants received fixed dosing of 2 mg aflibercept at injection intervals of 8 weeks
|
Aflibercept 2 mg Extended
n=154 participants at risk
Participants received flexible dosing of 2 mg aflibercept at injection intervals of \>=8 week
|
Aflibercept 2 mg PRN
n=154 participants at risk
Participants received monthly monitoring with 2 mg aflibercept injection pro re nata (PRN, as needed)
|
|---|---|---|---|
|
Eye disorders
Cataract
|
17.4%
27/155 • Number of events 37 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
18.8%
29/154 • Number of events 41 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
15.6%
24/154 • Number of events 35 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Cataract cortical
|
5.2%
8/155 • Number of events 11 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
4.5%
7/154 • Number of events 10 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
3.9%
6/154 • Number of events 10 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Cataract nuclear
|
5.8%
9/155 • Number of events 11 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.00%
0/154 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
4.5%
7/154 • Number of events 8 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Cataract subcapsular
|
4.5%
7/155 • Number of events 10 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
5.8%
9/154 • Number of events 10 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
5.2%
8/154 • Number of events 10 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Diabetic retinal oedema
|
7.7%
12/155 • Number of events 15 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
8.4%
13/154 • Number of events 17 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
9.1%
14/154 • Number of events 17 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Diabetic retinopathy
|
9.0%
14/155 • Number of events 18 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
9.1%
14/154 • Number of events 18 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
11.7%
18/154 • Number of events 23 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Macular oedema
|
5.2%
8/155 • Number of events 10 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
7.1%
11/154 • Number of events 14 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
11.0%
17/154 • Number of events 32 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Maculopathy
|
1.9%
3/155 • Number of events 4 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 2 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
8.4%
13/154 • Number of events 20 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Posterior capsule opacification
|
3.2%
5/155 • Number of events 6 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
5.8%
9/154 • Number of events 9 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
6.5%
10/154 • Number of events 12 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Retinal haemorrhage
|
2.6%
4/155 • Number of events 7 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.9%
3/154 • Number of events 3 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
6.5%
10/154 • Number of events 21 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Visual acuity reduced
|
16.1%
25/155 • Number of events 42 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
14.3%
22/154 • Number of events 30 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
14.3%
22/154 • Number of events 30 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Cystoid macular oedema
|
9.0%
14/155 • Number of events 25 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
7.8%
12/154 • Number of events 17 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
6.5%
10/154 • Number of events 15 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Eye disorders
Macular fibrosis
|
4.5%
7/155 • Number of events 7 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
3.9%
6/154 • Number of events 7 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
6.5%
10/154 • Number of events 11 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Conjunctivitis
|
2.6%
4/155 • Number of events 7 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
0.65%
1/154 • Number of events 1 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
5.2%
8/154 • Number of events 12 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Influenza
|
5.2%
8/155 • Number of events 8 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
1.9%
3/154 • Number of events 3 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
5.2%
8/154 • Number of events 8 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Infections and infestations
Nasopharyngitis
|
9.0%
14/155 • Number of events 18 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
9.1%
14/154 • Number of events 18 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
11.0%
17/154 • Number of events 24 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Investigations
Intraocular pressure increased
|
7.1%
11/155 • Number of events 14 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
2.6%
4/154 • Number of events 5 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
7.1%
11/154 • Number of events 14 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
15.5%
24/155 • Number of events 26 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
6.5%
10/154 • Number of events 10 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
9.7%
15/154 • Number of events 15 • After the first application of Aflibercept under this protocol and within 30 days after the last dose of study drug administration, assessed up to Week 100.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place