Trial Outcomes & Findings for Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD) (NCT NCT02540954)
NCT ID: NCT02540954
Last Updated: 2021-06-11
Results Overview
Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
336 participants
Primary outcome timeframe
From baseline to Week 52
Results posted on
2021-06-11
Participant Flow
Study was conducted at 76 centers in 14 countries or regions, between 29-SEP-2015 (first participant first visit) and 04-JUN-2020 (last participant last visit)
At baseline, 336 participants were randomized to one of 2 treatment groups; 168 participants were randomized to the extended-dosing group and 168 participants were randomized to the 2Q8 (2 mg aflibercept administered every 8 weeks) group.
Participant milestones
| Measure |
Aflibercept Extended Dosing
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Overall Study
STARTED
|
168
|
168
|
|
Overall Study
Treated
|
167
|
168
|
|
Overall Study
Post-baseline BCVA Assessment
|
165
|
167
|
|
Overall Study
COMPLETED
|
149
|
154
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
Reasons for withdrawal
| Measure |
Aflibercept Extended Dosing
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Death
|
0
|
3
|
|
Overall Study
Treatment failure
|
1
|
0
|
|
Overall Study
Other reason
|
4
|
2
|
Baseline Characteristics
The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
Baseline characteristics by cohort
| Measure |
Aflibercept Extended Dosing
n=167 Participants
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=168 Participants
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
Total
n=335 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.3 years
STANDARD_DEVIATION 8.3 • n=167 Participants
|
74.7 years
STANDARD_DEVIATION 7.0 • n=168 Participants
|
75.5 years
STANDARD_DEVIATION 7.7 • n=335 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=167 Participants
|
108 Participants
n=168 Participants
|
215 Participants
n=335 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=167 Participants
|
60 Participants
n=168 Participants
|
120 Participants
n=335 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=167 Participants
|
0 Participants
n=168 Participants
|
0 Participants
n=335 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
136 Participants
n=167 Participants
|
128 Participants
n=168 Participants
|
264 Participants
n=335 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=167 Participants
|
40 Participants
n=168 Participants
|
71 Participants
n=335 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=167 Participants
|
0 Participants
n=168 Participants
|
0 Participants
n=335 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=167 Participants
|
0 Participants
n=168 Participants
|
0 Participants
n=335 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=167 Participants
|
0 Participants
n=168 Participants
|
0 Participants
n=335 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=167 Participants
|
0 Participants
n=168 Participants
|
0 Participants
n=335 Participants
|
|
Race (NIH/OMB)
White
|
139 Participants
n=167 Participants
|
132 Participants
n=168 Participants
|
271 Participants
n=335 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=167 Participants
|
0 Participants
n=168 Participants
|
0 Participants
n=335 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=167 Participants
|
36 Participants
n=168 Participants
|
64 Participants
n=335 Participants
|
|
Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual
|
69.0 Letters read correctly
STANDARD_DEVIATION 12.1 • n=165 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
70.1 Letters read correctly
STANDARD_DEVIATION 10.9 • n=167 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
69.6 Letters read correctly
STANDARD_DEVIATION 11.5 • n=332 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
|
Central retinal thickness (CRT) in the study eye
|
257.3 μm
STANDARD_DEVIATION 67.8 • n=165 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
264.4 μm
STANDARD_DEVIATION 59.7 • n=167 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
260.9 μm
STANDARD_DEVIATION 63.8 • n=332 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
|
Choroidal neovascularization (CNV) area in the study eye
|
4.695 mm*2
STANDARD_DEVIATION 4.043 • n=165 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
5.060 mm*2
STANDARD_DEVIATION 4.105 • n=167 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
4.875 mm*2
STANDARD_DEVIATION 4.070 • n=332 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
|
Total score for National Eye Institute 25-Item Visual Function
|
72.889 Score on a scale
STANDARD_DEVIATION 18.414 • n=165 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
75.757 Score on a scale
STANDARD_DEVIATION 15.495 • n=167 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
74.340 Score on a scale
STANDARD_DEVIATION 17.034 • n=332 Participants • The Full Analysis Set included all randomized subjects who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
|
PRIMARY outcome
Timeframe: From baseline to Week 52Population: The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.
Outcome measures
| Measure |
Aflibercept Extended Dosing
n=165 Participants
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=167 Participants
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye
|
-0.3 Letters read correctly
Standard Deviation 7.5
|
-0.5 Letters read correctly
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: At week 52Population: The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.
Outcome measures
| Measure |
Aflibercept Extended Dosing
n=165 Participants
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=167 Participants
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Percentage of Participants Maintaining Vision in the Study Eye
|
95.2 Percentage of participants
|
94.0 Percentage of participants
|
SECONDARY outcome
Timeframe: At week 52Population: The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
Outcome measures
| Measure |
Aflibercept Extended Dosing
n=165 Participants
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=167 Participants
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye
|
24.2 Percentage of participants
|
21.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to week 52Population: The outcome measure was analyzed based on full analysis set (FAS) with number of participants evaluable for this specific end point.
Retinal characteristic was evaluated using Optical coherence tomography (OCT).
Outcome measures
| Measure |
Aflibercept Extended Dosing
n=165 Participants
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=167 Participants
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
|
-24.4 μm
Standard Deviation 55.2
|
-33.4 μm
Standard Deviation 47.1
|
SECONDARY outcome
Timeframe: From baseline to week 52Population: The outcome measure was analyzed based on full analysis set (FAS) with number of participants evaluable for this specific end point.
Choroidal neovascularization measured by optical coherence tomography (OCT).
Outcome measures
| Measure |
Aflibercept Extended Dosing
n=165 Participants
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=167 Participants
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye
|
0.274 mm*2
Standard Deviation 2.723
|
0.204 mm*2
Standard Deviation 2.813
|
SECONDARY outcome
Timeframe: At week 52Population: The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.
Outcome measures
| Measure |
Aflibercept Extended Dosing
n=165 Participants
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=167 Participants
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye
|
0 Percentage of participants
|
0.6 Percentage of participants
|
SECONDARY outcome
Timeframe: From baseline to week 52Population: The outcome measure was analyzed based on full analysis set (FAS) with number of participants evaluable for this specific end point.
National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) total score ranges from 0 to 100, where 100 represents the best possible score and 0 represents the worst.
Outcome measures
| Measure |
Aflibercept Extended Dosing
n=165 Participants
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=167 Participants
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire
|
0.186 Score on a scale
Standard Deviation 9.601
|
-1.694 Score on a scale
Standard Deviation 10.328
|
SECONDARY outcome
Timeframe: Started after the first application of aflibercept in the study and less than or equal to 30 days after the last dose of study drug over approximately 1.5 yearsPopulation: Number of participants with TEAE was analyzed based on safety analysis set (SAF) with number of participants evaluable.
Outcome measures
| Measure |
Aflibercept Extended Dosing
n=167 Participants
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=168 Participants
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Any TEAE
|
130 Participants
|
124 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAE)
Any serious TEAE
|
26 Participants
|
23 Participants
|
Adverse Events
Aflibercept Extended Dosing
Serious events: 26 serious events
Other events: 60 other events
Deaths: 0 deaths
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
Serious events: 23 serious events
Other events: 70 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Aflibercept Extended Dosing
n=167 participants at risk
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=168 participants at risk
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/167 • Number of events 2 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Cardiac disorders
Bradycardia
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
3/167 • Number of events 3 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Eye disorders
Retinal haemorrhage
|
1.2%
2/167 • Number of events 2 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Eye disorders
Retinal tear
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
General disorders
General physical health deterioration
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Endophthalmitis
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/167 • Number of events 2 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Septic shock
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Urinary tract infection
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Wound infection
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Urosepsis
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Infectious pleural effusion
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Fall
|
1.8%
3/167 • Number of events 3 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
2/167 • Number of events 2 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
1.2%
2/168 • Number of events 2 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
1.2%
2/168 • Number of events 2 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Nervous system disorders
Ischaemic stroke
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Surgical and medical procedures
Oesophageal prosthesis insertion
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/167 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.60%
1/168 • Number of events 2 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.60%
1/167 • Number of events 1 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
0.00%
0/168 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
Other adverse events
| Measure |
Aflibercept Extended Dosing
n=167 participants at risk
Aflibercept was administered 2mg per injection intravitreal (IVT) in the study eye in Aflibercept extended dosing. Flexible dosing interval is ≥ 8 weeks (no upper limit) based on visual and anatomic outcomes as judged by the investigator. When/if visual and anatomical outcomes indicated that the disease had re-activated, the treatment interval reverted to the last treatment interval in which the disease was inactive (ie, no signs of exudation were observed).
|
Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)
n=168 participants at risk
Aflibercept was administered 2mg per injection IVT in the study eye in Aflibercept 2Q8. Fixed dosing interval is 8 weeks (±3 days), modification of the treatment interval was not allowed.
|
|---|---|---|
|
Eye disorders
Cataract
|
10.2%
17/167 • Number of events 22 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
11.3%
19/168 • Number of events 27 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Eye disorders
Visual acuity reduced
|
8.4%
14/167 • Number of events 18 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
2.4%
4/168 • Number of events 6 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Eye disorders
Choroidal neovascularisation
|
5.4%
9/167 • Number of events 10 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
5.4%
9/168 • Number of events 9 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Eye disorders
Subretinal fluid
|
8.4%
14/167 • Number of events 17 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
8.3%
14/168 • Number of events 16 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
4.8%
8/167 • Number of events 9 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
6.0%
10/168 • Number of events 12 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Influenza
|
5.4%
9/167 • Number of events 9 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
5.4%
9/168 • Number of events 9 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
4/167 • Number of events 5 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
7.1%
12/168 • Number of events 15 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
|
Investigations
Intraocular pressure increased
|
4.2%
7/167 • Number of events 12 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
6.5%
11/168 • Number of events 19 • From after the first application of aflibercept in the study to 30 days after the last dose of study drug over approximately 1.5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60