Trial Outcomes & Findings for Aflibercept in Polypoidal Choroidal Vasculopathy (NCT NCT02120950)
NCT ID: NCT02120950
Last Updated: 2020-12-02
Results Overview
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
333 participants
Primary outcome timeframe
From Baseline to Week 52
Results posted on
2020-12-02
Participant Flow
The study was conducted at multiple centers in 8 countries worldwide starting from 29 May 2014 (first subject first visit). Primary completion reached on 12 Aug 2016.
Overall, 428 subjects were screened, of them 95 were failed in screening. Remaining 333 subjects received at least one treatment. Of them, 15 subjects discontinued study participation before week 12 and were not randomized. Remaining 318 were randomized.
Participant milestones
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
Aflibercept (Non-randomized)
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period), but discontinued study participation before randomization
|
|---|---|---|---|
|
Overall Study
STARTED
|
157
|
161
|
15
|
|
Overall Study
COMPLETED
|
137
|
147
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
14
|
15
|
Reasons for withdrawal
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
Aflibercept (Non-randomized)
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period), but discontinued study participation before randomization
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
3
|
|
Overall Study
Death
|
3
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
7
|
|
Overall Study
Other reasons
|
5
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
Baseline Characteristics
Aflibercept in Polypoidal Choroidal Vasculopathy
Baseline characteristics by cohort
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
70.4 Years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
70.6 Years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Baseline BCVA score
|
57.7 Letters
STANDARD_DEVIATION 11.3 • n=5 Participants
|
59.0 Letters
STANDARD_DEVIATION 11.5 • n=7 Participants
|
58.4 Letters
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Central Subfield Thickness
|
347.8 Micrometer
STANDARD_DEVIATION 118.9 • n=5 Participants
|
346.1 Micrometer
STANDARD_DEVIATION 117.5 • n=7 Participants
|
346.9 Micrometer
STANDARD_DEVIATION 118.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 52Population: Full Analysis Set (FAS) included all randomized subjects
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF)
|
10.7 Letters correctly read
Standard Deviation 11.3
|
10.8 Letters correctly read
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: At Week 52Population: FAS
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52
|
97.5 Percentage of subjects
|
96.9 Percentage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS
Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Percentage of Subjects Who Never Need Rescue Therapy in the First Year
|
87.9 Percentage of subjects
|
85.7 Percentage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Number of PDT Treatments in the Study Eye Before Week 52
|
0.2 PDT administrations
Standard Deviation 0.7
|
0.2 PDT administrations
Standard Deviation 0.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS with evaluable subjects for this outcome measure.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=154 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=160 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52
|
5.2 Aflibercept injections
Standard Deviation 1.1
|
5.1 Aflibercept injections
Standard Deviation 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Time to First Administration of PDT in the Study Eye Before Week 52
|
131.2 Days
Interval 80.0 to 278.0
|
128.2 Days
Interval 80.0 to 315.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye
|
10.7 Letters
Standard Deviation 11.3
|
10.8 Letters
Standard Deviation 10.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52
Gained ≥ 5
|
73.9 Percentage of subjects
|
78.9 Percentage of subjects
|
|
Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52
Gained ≥ 10
|
55.4 Percentage of subjects
|
57.1 Percentage of subjects
|
|
Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52
Gained ≥ 15
|
33.1 Percentage of subjects
|
36.6 Percentage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS
Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52
Lost ≥ 5
|
7.0 Percentage of subjects
|
5.6 Percentage of subjects
|
|
Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52
Lost ≥ 10
|
3.8 Percentage of subjects
|
3.1 Percentage of subjects
|
|
Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52
Lost ≥ 15
|
2.5 Percentage of subjects
|
3.1 Percentage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS with evaluable subjects for this outcome measure.
Complete polyp regression was defined as absent or indeterminate visual polyps on Indocyanine green angiography (ICGA) in the study eye.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=126 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=134 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Percentage of Subjects With Complete Polyp Regression at Week 52
|
38.9 Percetage of subjects
|
44.8 Percetage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS with evaluable subjects for this outcome measure.
Leakage is the release of fluorescein dye from diseased retinal vessels. Leakage area is defined as the area showing presence of fluorescein dye in the late stages of fluorescein angiography.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=140 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=149 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52
|
-1.3 Square millimeter
Standard Deviation 3.6
|
-1.2 Square millimeter
Standard Deviation 3.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS with evaluable subjects for this outcome measure.
Retinal and lesion characteristics, such as central retinal thickness (CRT), were evaluated by OCT in both eyes at every study visit. CRT was measured using optical coherence tomography to determine the average thickness of the retina in a circle with 1 millimeter of diameter centered on the fovea. This value is reported by some OCT devices as central subfield thickness (CST).
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=136 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=150 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52
|
-137.7 Millimeter
Standard Deviation 116.0
|
-143.5 Millimeter
Standard Deviation 110.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS with evaluable subjects for this outcome measure.
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=143 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=153 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52
|
4.7 Scores on a scale
Standard Deviation 10.3
|
7.3 Scores on a scale
Standard Deviation 12.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Week 52Population: FAS with evaluable subjects for this outcome measure.
Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.
Outcome measures
| Measure |
Aflibercept + Sham Photodynamic Therapy (PDT)
n=157 Participants
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy).
|
Aflibercept + Active PDT
n=161 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed
|
|---|---|---|
|
Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52
|
12.1 Percentage of subjects
|
14.3 Percentage of subjects
|
Adverse Events
Aflibercept + Sham PDT
Serious events: 27 serious events
Other events: 59 other events
Deaths: 3 deaths
Aflibercept + Active PDT
Serious events: 25 serious events
Other events: 49 other events
Deaths: 0 deaths
Aflibercept (Non-randomized)
Serious events: 4 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Aflibercept + Sham PDT
n=157 participants at risk
Subjects received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period).At Week 12, subjects were assessed for the rescue treatment and randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed.
|
Aflibercept + Active PDT
n=161 participants at risk
Subjects received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were assessed for the rescue treatment and randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed.
|
Aflibercept (Non-randomized)
n=15 participants at risk
Subjects received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period), but discontinued study participation before randomization.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Cardiac disorders
Angina unstable
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Cardiac disorders
Arrhythmia
|
1.3%
2/157 • Number of events 2 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Cataract
|
1.3%
2/157 • Number of events 2 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 2 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
1.2%
2/161 • Number of events 2 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
6.7%
1/15 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Gastrointestinal disorders
Ileus
|
0.64%
1/157 • Number of events 2 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
General disorders
Death
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
6.7%
1/15 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Infections and infestations
Ear infection
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Infections and infestations
Endophthalmitis
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
1.9%
3/161 • Number of events 4 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Infections and infestations
Septic shock
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
2/157 • Number of events 3 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.3%
2/157 • Number of events 2 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Afferent loop syndrome
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
6.7%
1/15 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Nervous system disorders
Senile dementia
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
6.7%
1/15 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Renal and urinary disorders
Haematuria
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Reproductive system and breast disorders
Cystocele
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 13 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/157 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Surgical and medical procedures
Transcatheter arterial chemoembolisation
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Vascular disorders
Varicose vein
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
Other adverse events
| Measure |
Aflibercept + Sham PDT
n=157 participants at risk
Subjects received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period).At Week 12, subjects were assessed for the rescue treatment and randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed.
|
Aflibercept + Active PDT
n=161 participants at risk
Subjects received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were assessed for the rescue treatment and randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy) until Week 52. Between Week 52 and Week 96, the treatment interval could have been extended (typically in increments of 1 or 2 weeks) at the discretion of the investigator when the visual and anatomic outcomes allowed.
|
Aflibercept (Non-randomized)
n=15 participants at risk
Subjects received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period), but discontinued study participation before randomization.
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
6.4%
10/157 • Number of events 31 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
3.1%
5/161 • Number of events 8 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Dry eye
|
3.8%
6/157 • Number of events 11 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
6.8%
11/161 • Number of events 22 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Ocular hypertension
|
1.9%
3/157 • Number of events 4 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
6.7%
1/15 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Visual acuity reduced
|
4.5%
7/157 • Number of events 7 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
5.6%
9/161 • Number of events 10 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Vitreous floaters
|
5.7%
9/157 • Number of events 10 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.62%
1/161 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Eye disorders
Retinal pigment epithelial tear
|
2.5%
4/157 • Number of events 4 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
6.7%
1/15 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
15.9%
25/157 • Number of events 41 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
11.2%
18/161 • Number of events 25 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Investigations
Intraocular pressure increased
|
3.8%
6/157 • Number of events 18 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
5.6%
9/161 • Number of events 20 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/15 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Psychiatric disorders
Depression
|
0.64%
1/157 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
0.00%
0/161 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
6.7%
1/15 • Number of events 1 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
|
Vascular disorders
Hypertension
|
3.8%
6/157 • Number of events 6 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
8.1%
13/161 • Number of events 13 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
13.3%
2/15 • Number of events 2 • From start of study treatment up to 30 days after the last treatment. Approximately 100 weeks.
The SAF (N=333) included all subjects who received any study drug under this protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60