Trial Outcomes & Findings for Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO) (NCT NCT01012973)
NCT ID: NCT01012973
Last Updated: 2014-11-03
Results Overview
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
177 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2014-11-03
Participant Flow
Participant milestones
| Measure |
Aflibercept Injection First, Then Aflibercept Injection
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
|
Sham Treatment First, Then Aflibercept Injection
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
71
|
|
Overall Study
Participants Received Treatment
|
104
|
68
|
|
Overall Study
Fulfilled Requirements of FAS Population
|
103
|
68
|
|
Overall Study
Completed Week 24, From FAS
|
97
|
57
|
|
Overall Study
Completed Week 52, From FAS
|
91
|
52
|
|
Overall Study
COMPLETED
|
90
|
52
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
Reasons for withdrawal
| Measure |
Aflibercept Injection First, Then Aflibercept Injection
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
|
Sham Treatment First, Then Aflibercept Injection
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
(Overseas travel - indefinite period)
|
1
|
0
|
|
Overall Study
Increase in vis. acuity, never injected
|
0
|
1
|
|
Overall Study
Protocol Violation
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
Baseline Characteristics
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)
Baseline characteristics by cohort
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=104 Participants
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
|
Sham Treatment
n=68 Participants
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
61.5 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline Best Corrected Visual Acuity (BCVA) letter scores
|
53.5 Letters correctly read
STANDARD_DEVIATION 15.7 • n=5 Participants
|
50.9 Letters correctly read
STANDARD_DEVIATION 15.4 • n=7 Participants
|
52.5 Letters correctly read
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Number of participants with baseline retinal perfusion
Perfused
|
90 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Number of participants with baseline retinal perfusion
Nonperfused
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Number of participants with baseline retinal perfusion
Indeterminate
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Baseline Retinal Thickness by Optical Coherence Tomography (OCT)
|
682.78 microns
STANDARD_DEVIATION 233.36 • n=5 Participants
|
638.66 microns
STANDARD_DEVIATION 224.69 • n=7 Participants
|
665.34 microns
STANDARD_DEVIATION 230.33 • n=5 Participants
|
|
Baseline intraocular pressure
|
15.2 mm Hg
STANDARD_DEVIATION 2.8 • n=5 Participants
|
14.4 mm Hg
STANDARD_DEVIATION 2.7 • n=7 Participants
|
14.9 mm Hg
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Number of participants with time since Central retinal vein occlusion (CRVO) diagnosis
>= 2 months
|
46 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Number of participants with time since Central retinal vein occlusion (CRVO) diagnosis
< 2 months
|
56 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Number of participants with time since Central retinal vein occlusion (CRVO) diagnosis
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Baseline National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score
|
79.66 scores on a scale
STANDARD_DEVIATION 13.06 • n=5 Participants
|
78.94 scores on a scale
STANDARD_DEVIATION 14.00 • n=7 Participants
|
79.38 scores on a scale
STANDARD_DEVIATION 13.40 • n=5 Participants
|
|
European questionnaire 5 dimensions (EQ-5D) total score
|
0.87 score on a scale
STANDARD_DEVIATION 0.15 • n=5 Participants
|
0.86 score on a scale
STANDARD_DEVIATION 0.16 • n=7 Participants
|
0.87 score on a scale
STANDARD_DEVIATION 0.15 • n=5 Participants
|
|
Race
Asian
|
26 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race
White
|
75 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Full analysis set
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. Nominator = (Number of participants who maintained vision \* 100); Denominator = Number of participants analyzed.
Outcome measures
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=103 Participants
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
|
Sham Treatment
n=68 Participants
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
|
|---|---|---|
|
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures
|
60.2 Percentage of participants
|
22.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full analysis set
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.
Outcome measures
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=103 Participants
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
|
Sham Treatment
n=68 Participants
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
|
|---|---|---|
|
Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)
|
71.6 Letters correctly read
Standard Deviation 17.1
|
54.3 Letters correctly read
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF
Outcome measures
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=103 Participants
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
|
Sham Treatment
n=67 Participants
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
|
|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
|
-448.58 microns
Standard Deviation 256.02
|
-169.27 microns
Standard Deviation 224.72
|
SECONDARY outcome
Timeframe: From baseline until Week 24Population: Full analysis set
Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24
Outcome measures
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=103 Participants
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
|
Sham Treatment
n=68 Participants
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
|
|---|---|---|
|
Percentage of Participants Who Developed Neovascularization During the First 24 Weeks
Any neovascularization
|
2.9 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants Who Developed Neovascularization During the First 24 Weeks
Anterior segment neovascularization
|
1.9 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants Who Developed Neovascularization During the First 24 Weeks
Neovascularization of the optic disc (NVD)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Who Developed Neovascularization During the First 24 Weeks
Neovascularization elsewhere in the fundus (NVE)
|
1.0 Percentage of participants
|
2.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF
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 Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=96 Participants
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
|
Sham Treatment
n=65 Participants
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
|
|---|---|---|
|
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF
|
7.46 Scores on a scale
Standard Deviation 9.55
|
3.55 Scores on a scale
Standard Deviation 9.74
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full-Analysis Set with assessment for this outcome measure; imputation technique: LOCF
EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).
Outcome measures
| Measure |
Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
n=95 Participants
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
|
Sham Treatment
n=64 Participants
Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
|
|---|---|---|
|
Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF
|
0.029 Scores on a scale
Standard Deviation 0.139
|
-0.002 Scores on a scale
Standard Deviation 0.195
|
Adverse Events
Aflibercept Injection (Until Week 20)
Serious events: 8 serious events
Other events: 52 other events
Deaths: 0 deaths
Sham Treatment (Until Week 20)
Serious events: 8 serious events
Other events: 44 other events
Deaths: 0 deaths
Aflibercept Injection (Until Week 48)
Serious events: 14 serious events
Other events: 66 other events
Deaths: 0 deaths
Sham Treatment (Until Week 48)
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Aflibercept Injection Continued (Until Week 68)
Serious events: 4 serious events
Other events: 38 other events
Deaths: 0 deaths
Sham Treatment Then Aflibercept Injection (Until Week 68)
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aflibercept Injection (Until Week 20)
n=104 participants at risk
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
|
Sham Treatment (Until Week 20)
n=68 participants at risk
Participants received sham treatment administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
|
Aflibercept Injection (Until Week 48)
n=97 participants at risk
Participants who continued the study drug until Week 24 received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
|
Sham Treatment (Until Week 48)
n=57 participants at risk
Participants who continued the study drug until Week 24 received sham treatment administered every 4 weeks from Week 24 to Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
|
Aflibercept Injection Continued (Until Week 68)
n=91 participants at risk
Participants on IAI who continued the study drug until Week 52, received 2 mg dose of IAI depending on the study retreatment criteria at Week 52, 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
|
Sham Treatment Then Aflibercept Injection (Until Week 68)
n=52 participants at risk
Participants on sham treatment switched to IAI, received a 2 mg dose of IAI at Week 52 and depending on the study retreatment criteria at Week 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
1.9%
1/52
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
1.9%
1/52
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
1.9%
1/52
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
1.9%
1/52
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
1.9%
1/52
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/104
|
0.00%
0/68
|
1.0%
1/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Glaucoma
|
0.00%
0/104
|
1.5%
1/68
|
0.00%
0/97
|
1.8%
1/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Iris neovascularisation
|
0.96%
1/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/104
|
0.00%
0/68
|
1.0%
1/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Macular ischaemia
|
0.00%
0/104
|
0.00%
0/68
|
1.0%
1/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Macular oedema
|
0.00%
0/104
|
2.9%
2/68
|
4.1%
4/97
|
0.00%
0/57
|
1.1%
1/91
|
0.00%
0/52
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/104
|
0.00%
0/68
|
1.0%
1/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/104
|
1.5%
1/68
|
1.0%
1/97
|
0.00%
0/57
|
2.2%
2/91
|
0.00%
0/52
|
|
Eye disorders
Vitreous detachment
|
0.96%
1/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/104
|
1.5%
1/68
|
1.0%
1/97
|
1.8%
1/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
1.1%
1/91
|
0.00%
0/52
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/104
|
0.00%
0/68
|
1.0%
1/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Infections and infestations
Furuncle
|
0.96%
1/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/104
|
1.5%
1/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Infections and infestations
Pneumonia
|
0.00%
0/104
|
1.5%
1/68
|
1.0%
1/97
|
1.8%
1/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
1.8%
1/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/104
|
1.5%
1/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
1.9%
1/52
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.96%
1/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/104
|
1.5%
1/68
|
1.0%
1/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/104
|
1.5%
1/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.96%
1/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/104
|
1.5%
1/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
1.1%
1/91
|
0.00%
0/52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/104
|
0.00%
0/68
|
1.0%
1/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer stage unspecified
|
0.96%
1/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/104
|
0.00%
0/68
|
1.0%
1/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Nervous system disorders
Syncope
|
0.00%
0/104
|
0.00%
0/68
|
1.0%
1/97
|
3.5%
2/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
1.8%
1/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
1.8%
1/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal granuloma
|
0.00%
0/104
|
1.5%
1/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
1.9%
1/52
|
|
Surgical and medical procedures
Ischaemic heart disease prophylaxis
|
0.96%
1/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Vascular disorders
Circulatory collapse
|
0.96%
1/104
|
0.00%
0/68
|
0.00%
0/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
Other adverse events
| Measure |
Aflibercept Injection (Until Week 20)
n=104 participants at risk
Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
|
Sham Treatment (Until Week 20)
n=68 participants at risk
Participants received sham treatment administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
|
Aflibercept Injection (Until Week 48)
n=97 participants at risk
Participants who continued the study drug until Week 24 received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
|
Sham Treatment (Until Week 48)
n=57 participants at risk
Participants who continued the study drug until Week 24 received sham treatment administered every 4 weeks from Week 24 to Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
|
Aflibercept Injection Continued (Until Week 68)
n=91 participants at risk
Participants on IAI who continued the study drug until Week 52, received 2 mg dose of IAI depending on the study retreatment criteria at Week 52, 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
|
Sham Treatment Then Aflibercept Injection (Until Week 68)
n=52 participants at risk
Participants on sham treatment switched to IAI, received a 2 mg dose of IAI at Week 52 and depending on the study retreatment criteria at Week 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.96%
1/104
|
0.00%
0/68
|
0.00%
0/97
|
5.3%
3/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Conjunctival haemorrhage
|
9.6%
10/104
|
4.4%
3/68
|
3.1%
3/97
|
0.00%
0/57
|
9.9%
9/91
|
5.8%
3/52
|
|
Eye disorders
Eye irritation
|
2.9%
3/104
|
10.3%
7/68
|
4.1%
4/97
|
1.8%
1/57
|
1.1%
1/91
|
3.8%
2/52
|
|
Eye disorders
Eye pain
|
11.5%
12/104
|
4.4%
3/68
|
6.2%
6/97
|
3.5%
2/57
|
1.1%
1/91
|
0.00%
0/52
|
|
Eye disorders
Foreign body sensation in eyes
|
5.8%
6/104
|
7.4%
5/68
|
2.1%
2/97
|
0.00%
0/57
|
1.1%
1/91
|
0.00%
0/52
|
|
Eye disorders
Lacrimation increased
|
2.9%
3/104
|
5.9%
4/68
|
3.1%
3/97
|
7.0%
4/57
|
1.1%
1/91
|
3.8%
2/52
|
|
Eye disorders
Macular fibrosis
|
0.96%
1/104
|
1.5%
1/68
|
5.2%
5/97
|
7.0%
4/57
|
0.00%
0/91
|
5.8%
3/52
|
|
Eye disorders
Macular ischaemia
|
6.7%
7/104
|
7.4%
5/68
|
3.1%
3/97
|
1.8%
1/57
|
0.00%
0/91
|
1.9%
1/52
|
|
Eye disorders
Macular oedema
|
1.9%
2/104
|
13.2%
9/68
|
30.9%
30/97
|
12.3%
7/57
|
18.7%
17/91
|
3.8%
2/52
|
|
Eye disorders
Ocular hyperaemia
|
4.8%
5/104
|
5.9%
4/68
|
2.1%
2/97
|
1.8%
1/57
|
4.4%
4/91
|
1.9%
1/52
|
|
Eye disorders
Optic disc vascular disorder
|
4.8%
5/104
|
4.4%
3/68
|
3.1%
3/97
|
5.3%
3/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Retinal exudates
|
7.7%
8/104
|
7.4%
5/68
|
4.1%
4/97
|
5.3%
3/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Retinal haemorrhage
|
3.8%
4/104
|
8.8%
6/68
|
11.3%
11/97
|
8.8%
5/57
|
5.5%
5/91
|
3.8%
2/52
|
|
Eye disorders
Retinal vascular disorder
|
5.8%
6/104
|
10.3%
7/68
|
10.3%
10/97
|
3.5%
2/57
|
0.00%
0/91
|
3.8%
2/52
|
|
Eye disorders
Visual acuity reduced
|
1.9%
2/104
|
10.3%
7/68
|
10.3%
10/97
|
1.8%
1/57
|
7.7%
7/91
|
1.9%
1/52
|
|
Eye disorders
Vitreous detachment
|
1.9%
2/104
|
1.5%
1/68
|
7.2%
7/97
|
0.00%
0/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Eye disorders
Vitreous floaters
|
5.8%
6/104
|
0.00%
0/68
|
1.0%
1/97
|
1.8%
1/57
|
1.1%
1/91
|
1.9%
1/52
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/104
|
1.5%
1/68
|
0.00%
0/97
|
5.3%
3/57
|
0.00%
0/91
|
0.00%
0/52
|
|
Infections and infestations
Influenza
|
1.9%
2/104
|
0.00%
0/68
|
5.2%
5/97
|
1.8%
1/57
|
1.1%
1/91
|
1.9%
1/52
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
8/104
|
8.8%
6/68
|
10.3%
10/97
|
19.3%
11/57
|
4.4%
4/91
|
3.8%
2/52
|
|
Investigations
Intraocular pressure increased
|
8.7%
9/104
|
5.9%
4/68
|
14.4%
14/97
|
3.5%
2/57
|
2.2%
2/91
|
1.9%
1/52
|
|
Investigations
Visual acuity tests abnormal
|
0.00%
0/104
|
1.5%
1/68
|
5.2%
5/97
|
0.00%
0/57
|
1.1%
1/91
|
0.00%
0/52
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.96%
1/104
|
7.4%
5/68
|
2.1%
2/97
|
1.8%
1/57
|
2.2%
2/91
|
0.00%
0/52
|
|
Nervous system disorders
Headache
|
6.7%
7/104
|
5.9%
4/68
|
4.1%
4/97
|
1.8%
1/57
|
1.1%
1/91
|
1.9%
1/52
|
|
Vascular disorders
Hypertension
|
3.8%
4/104
|
4.4%
3/68
|
4.1%
4/97
|
7.0%
4/57
|
3.3%
3/91
|
3.8%
2/52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publishing of result communication only after Bayer´s written approval. Manuscript to Bayer sixty days before public release. If no written Bayer comment within 60 days consider approval given. If multi-site study, principal investigator (PI) not do independently publish results before publication of the multi-site paper, but PI not restricted from 24 months from study to completion onwards.
- Publication restrictions are in place
Restriction type: OTHER