Trial Outcomes & Findings for Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement (NCT NCT01783886)
NCT ID: NCT01783886
Last Updated: 2016-05-12
Results Overview
Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
381 participants
Primary outcome timeframe
Baseline up to week 52
Results posted on
2016-05-12
Participant Flow
The study was conducted at centers in China, Hong Kong, South Korea, and Russian Federation between 18 February 2013 (first participant first visit) and 09 March 2015 (last participant last visit) (data cut-off date).
Overall 539 participants were screened, of them 381 participants were randomized, and 378 participants were allocated to treatment.
Participant milestones
| Measure |
Intravitreal Aflibercept Injection 2Q4
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
127
|
127
|
127
|
|
Overall Study
Participants Received Treatment
|
127
|
127
|
124
|
|
Overall Study
COMPLETED
|
122
|
116
|
117
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
10
|
Reasons for withdrawal
| Measure |
Intravitreal Aflibercept Injection 2Q4
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
|
Overall Study
Protocol deviation
|
0
|
0
|
2
|
|
Overall Study
Withdrawal of consent by participant
|
1
|
3
|
4
|
|
Overall Study
Adverse Event
|
4
|
5
|
4
|
Baseline Characteristics
Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement
Baseline characteristics by cohort
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=127 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) 2Q4 over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=127 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=124 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
Total
n=378 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
101 participants
n=5 Participants
|
101 participants
n=7 Participants
|
99 participants
n=5 Participants
|
301 participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
Other Asia-Pacific (Hong Kong, Korea)
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
48 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to week 52Population: Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA. FAS with assessment for this outcome measure.
Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=127 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=126 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=124 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)
|
13.7 Letters correctly read
Standard Deviation 8.4
|
12.8 Letters correctly read
Standard Deviation 9.5
|
-0.2 Letters correctly read
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Baseline up to week 52Population: FAS.
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=127 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=126 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=124 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
|
70.9 Percentage of participants
|
62.7 Percentage of participants
|
23.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to week 52Population: FAS.
Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=127 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=126 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=124 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF
|
43.3 Percentage of participants
|
36.5 Percentage of participants
|
12.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to week 52Population: FAS.
ETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (DR) (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=122 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=122 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=120 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants With a Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF
|
60.7 Percentage of participants
|
62.3 Percentage of participants
|
21.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to week 52Population: FAS with assessment for this outcome measure.
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=126 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=126 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=124 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF
|
-238.7 micrometer
Standard Deviation 172.5
|
-234.7 micrometer
Standard Deviation 160.8
|
-109.3 micrometer
Standard Deviation 206.9
|
SECONDARY outcome
Timeframe: Baseline up to week 52Population: FAS with assessment 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 that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=124 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=122 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=119 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF
|
6.65 Scores on a scale
Standard Deviation 23.86
|
7.28 Scores on a scale
Standard Deviation 22.95
|
0.04 Scores on a scale
Standard Deviation 24.39
|
SECONDARY outcome
Timeframe: Baseline up to week 52Population: FAS with assessment 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 that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.
Outcome measures
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=124 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=122 Participants
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=119 Participants
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF
|
3.93 Scores on a scale
Standard Deviation 22.36
|
10.25 Scores on a scale
Standard Deviation 21.44
|
0.04 Scores on a scale
Standard Deviation 23.14
|
Adverse Events
Intravitreal Aflibercept Injection 2Q4
Serious events: 19 serious events
Other events: 87 other events
Deaths: 0 deaths
Intravitreal Aflibercept Injection 2Q8
Serious events: 22 serious events
Other events: 83 other events
Deaths: 0 deaths
Macular Laser Photocoagulation
Serious events: 24 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=127 participants at risk
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=127 participants at risk
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=124 participants at risk
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Cataract
|
1.6%
2/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Glaucoma
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
1.6%
2/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Hyphaema
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Papilloedema
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Ulcerative keratitis
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
1.6%
2/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Vitreous haemorrhage
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
3.2%
4/124 • From the start of study treatment up to 52 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
General disorders
Impaired healing
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Infections and infestations
Lung infection
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Infections and infestations
Peritonitis
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Investigations
Blood glucose increased
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
1.6%
2/124 • From the start of study treatment up to 52 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
1.6%
2/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Renal osteodystrophy
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant lymphoid neoplasm
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Nervous system disorders
Cerebral infarction
|
1.6%
2/127 • From the start of study treatment up to 52 weeks
|
1.6%
2/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Nervous system disorders
Diabetic neuropathy
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
1.6%
2/124 • From the start of study treatment up to 52 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.81%
1/124 • From the start of study treatment up to 52 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/127 • From the start of study treatment up to 52 weeks
|
0.00%
0/124 • From the start of study treatment up to 52 weeks
|
Other adverse events
| Measure |
Intravitreal Aflibercept Injection 2Q4
n=127 participants at risk
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF \[vascular endothelial growth factor\] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
|
Intravitreal Aflibercept Injection 2Q8
n=127 participants at risk
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
|
Macular Laser Photocoagulation
n=124 participants at risk
Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.79%
1/127 • From the start of study treatment up to 52 weeks
|
3.1%
4/127 • From the start of study treatment up to 52 weeks
|
5.6%
7/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
14.2%
18/127 • From the start of study treatment up to 52 weeks
|
10.2%
13/127 • From the start of study treatment up to 52 weeks
|
4.8%
6/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Diabetic retinal oedema
|
13.4%
17/127 • From the start of study treatment up to 52 weeks
|
10.2%
13/127 • From the start of study treatment up to 52 weeks
|
12.1%
15/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Diabetic retinopathy
|
3.9%
5/127 • From the start of study treatment up to 52 weeks
|
5.5%
7/127 • From the start of study treatment up to 52 weeks
|
5.6%
7/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Macular fibrosis
|
4.7%
6/127 • From the start of study treatment up to 52 weeks
|
5.5%
7/127 • From the start of study treatment up to 52 weeks
|
3.2%
4/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Macular oedema
|
6.3%
8/127 • From the start of study treatment up to 52 weeks
|
7.9%
10/127 • From the start of study treatment up to 52 weeks
|
7.3%
9/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Retinal aneurysm
|
7.1%
9/127 • From the start of study treatment up to 52 weeks
|
10.2%
13/127 • From the start of study treatment up to 52 weeks
|
8.1%
10/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Retinal exudates
|
6.3%
8/127 • From the start of study treatment up to 52 weeks
|
10.2%
13/127 • From the start of study treatment up to 52 weeks
|
4.0%
5/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Retinal haemorrhage
|
11.0%
14/127 • From the start of study treatment up to 52 weeks
|
13.4%
17/127 • From the start of study treatment up to 52 weeks
|
9.7%
12/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Vision blurred
|
3.1%
4/127 • From the start of study treatment up to 52 weeks
|
5.5%
7/127 • From the start of study treatment up to 52 weeks
|
2.4%
3/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Visual acuity reduced
|
9.4%
12/127 • From the start of study treatment up to 52 weeks
|
11.0%
14/127 • From the start of study treatment up to 52 weeks
|
19.4%
24/124 • From the start of study treatment up to 52 weeks
|
|
Eye disorders
Vitreous haemorrhage
|
3.1%
4/127 • From the start of study treatment up to 52 weeks
|
2.4%
3/127 • From the start of study treatment up to 52 weeks
|
5.6%
7/124 • From the start of study treatment up to 52 weeks
|
|
Infections and infestations
Conjunctivitis
|
6.3%
8/127 • From the start of study treatment up to 52 weeks
|
2.4%
3/127 • From the start of study treatment up to 52 weeks
|
4.0%
5/124 • From the start of study treatment up to 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
8/127 • From the start of study treatment up to 52 weeks
|
7.1%
9/127 • From the start of study treatment up to 52 weeks
|
5.6%
7/124 • From the start of study treatment up to 52 weeks
|
|
Investigations
Glycosylated haemoglobin increased
|
3.9%
5/127 • From the start of study treatment up to 52 weeks
|
7.1%
9/127 • From the start of study treatment up to 52 weeks
|
4.0%
5/124 • From the start of study treatment up to 52 weeks
|
|
Investigations
Visual acuity tests abnormal
|
7.1%
9/127 • From the start of study treatment up to 52 weeks
|
2.4%
3/127 • From the start of study treatment up to 52 weeks
|
12.1%
15/124 • From the start of study treatment up to 52 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
9.4%
12/127 • From the start of study treatment up to 52 weeks
|
7.9%
10/127 • From the start of study treatment up to 52 weeks
|
8.9%
11/124 • From the start of study treatment up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
7/127 • From the start of study treatment up to 52 weeks
|
2.4%
3/127 • From the start of study treatment up to 52 weeks
|
2.4%
3/124 • From the start of study treatment up to 52 weeks
|
|
Vascular disorders
Hypertension
|
7.9%
10/127 • From the start of study treatment up to 52 weeks
|
11.8%
15/127 • From the start of study treatment up to 52 weeks
|
6.5%
8/124 • From the start of study treatment up to 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER