Trial Outcomes & Findings for Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema (NCT NCT01627249)
NCT ID: NCT01627249
Last Updated: 2020-08-10
Results Overview
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
660 participants
Primary outcome timeframe
Baseline to 1-year
Results posted on
2020-08-10
Participant Flow
Participant milestones
| Measure |
Aflibercept
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Overall Study
STARTED
|
224
|
218
|
218
|
|
Overall Study
COMPLETED
|
208
|
206
|
206
|
|
Overall Study
NOT COMPLETED
|
16
|
12
|
12
|
Reasons for withdrawal
| Measure |
Aflibercept
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
12
|
6
|
9
|
|
Overall Study
Missed Visit
|
1
|
1
|
0
|
Baseline Characteristics
Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Aflibercept
n=224 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=218 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=218 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Total
n=660 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
|
60 years
STANDARD_DEVIATION 10 • n=5 Participants
|
62 years
STANDARD_DEVIATION 10 • n=7 Participants
|
60 years
STANDARD_DEVIATION 11 • n=5 Participants
|
61 years
STANDARD_DEVIATION 10 • n=4 Participants
|
|
Sex/Gender, Customized
Women
|
110 participants
n=5 Participants
|
103 participants
n=7 Participants
|
94 participants
n=5 Participants
|
307 participants
n=4 Participants
|
|
Sex/Gender, Customized
Men
|
114 participants
n=5 Participants
|
115 participants
n=7 Participants
|
124 participants
n=5 Participants
|
353 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
145 participants
n=5 Participants
|
139 participants
n=7 Participants
|
146 participants
n=5 Participants
|
430 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
32 participants
n=5 Participants
|
37 participants
n=7 Participants
|
36 participants
n=5 Participants
|
105 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
37 participants
n=5 Participants
|
36 participants
n=7 Participants
|
30 participants
n=5 Participants
|
103 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/other Pacific Islander
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskin Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown/not reported
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Diabetes Type
Type 1
|
22 participants
n=5 Participants
|
12 participants
n=7 Participants
|
16 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Diabetes Type
Type 2
|
196 participants
n=5 Participants
|
205 participants
n=7 Participants
|
196 participants
n=5 Participants
|
597 participants
n=4 Participants
|
|
Diabetes Type
Uncertain
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Prior Myocardial Infarction
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Prior Coronary Artery Disease
|
22 participants
n=5 Participants
|
27 participants
n=7 Participants
|
34 participants
n=5 Participants
|
83 participants
n=4 Participants
|
|
Prior Stroke
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
10 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
Prior Transient Ischemic attacks
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Prior Hypertension
|
177 participants
n=5 Participants
|
181 participants
n=7 Participants
|
175 participants
n=5 Participants
|
533 participants
n=4 Participants
|
|
Visual Acuity Letter Score
|
69 units on a scale
n=5 Participants
|
69 units on a scale
n=7 Participants
|
68 units on a scale
n=5 Participants
|
69 units on a scale
n=4 Participants
|
|
OCT Central Subfield
|
387 Microns
n=5 Participants
|
376 Microns
n=7 Participants
|
390 Microns
n=5 Participants
|
387 Microns
n=4 Participants
|
|
Lens Status
Phakic
|
166 participants
n=5 Participants
|
160 participants
n=7 Participants
|
173 participants
n=5 Participants
|
499 participants
n=4 Participants
|
|
Lens Status
Pseudophakic
|
58 participants
n=5 Participants
|
58 participants
n=7 Participants
|
45 participants
n=5 Participants
|
161 participants
n=4 Participants
|
|
Diabetic Retinopathy Severity (ETDRS Level)
Absent of minimal NPDR
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Diabetic Retinopathy Severity (ETDRS Level)
Mild to moderately severe NPDR
|
150 participants
n=5 Participants
|
131 participants
n=7 Participants
|
145 participants
n=5 Participants
|
426 participants
n=4 Participants
|
|
Diabetic Retinopathy Severity (ETDRS Level)
Severe NPDR
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
18 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Diabetic Retinopathy Severity (ETDRS Level)
Prior PRP; without current PDR
|
17 participants
n=5 Participants
|
21 participants
n=7 Participants
|
16 participants
n=5 Participants
|
54 participants
n=4 Participants
|
|
Diabetic Retinopathy Severity (ETDRS Level)
Mild to moderate PDR
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
23 participants
n=5 Participants
|
82 participants
n=4 Participants
|
|
Diabetic Retinopathy Severity (ETDRS Level)
High risk PDR
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Diabetic Retinopathy Severity (ETDRS Level)
Missing
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
2 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Prior Focal/Grid Laser for DME
|
80 participants
n=5 Participants
|
84 participants
n=7 Participants
|
80 participants
n=5 Participants
|
244 participants
n=4 Participants
|
|
Prior Anti-VEGF for DME
|
24 participants
n=5 Participants
|
31 participants
n=7 Participants
|
29 participants
n=5 Participants
|
84 participants
n=4 Participants
|
|
Prior other treatment for DME
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Prior PRP
|
32 participants
n=5 Participants
|
40 participants
n=7 Participants
|
35 participants
n=5 Participants
|
107 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 1-yearPopulation: Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Outcome measures
| Measure |
Aflibercept
n=208 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=206 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=206 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year
|
13.3 units on a scale
Standard Deviation 11.1
|
9.7 units on a scale
Standard Deviation 10.1
|
11.2 units on a scale
Standard Deviation 9.4
|
PRIMARY outcome
Timeframe: Baseline to 1-yearPopulation: Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Outcome measures
| Measure |
Aflibercept
n=102 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=102 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=101 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69
|
18.9 units on a scale
Standard Deviation 11.5
|
11.8 units on a scale
Standard Deviation 12.0
|
14.2 units on a scale
Standard Deviation 10.6
|
PRIMARY outcome
Timeframe: Baseline to 1-yearPopulation: Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Outcome measures
| Measure |
Aflibercept
n=106 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=104 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=105 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69
|
8.0 units on a scale
Standard Deviation 7.6
|
7.5 units on a scale
Standard Deviation 7.4
|
8.3 units on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: baseline to 1-yearPopulation: In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.
All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center. Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes.
Outcome measures
| Measure |
Aflibercept
n=205 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=203 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=201 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Overall Change in Optical Coherence Tomography Central Subfield Thickness
|
-169 microns
Standard Deviation 138
|
-101 microns
Standard Deviation 121
|
-147 microns
Standard Deviation 137
|
SECONDARY outcome
Timeframe: baseline to 1-yearPopulation: In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.
All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center. Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes.
Outcome measures
| Measure |
Aflibercept
n=101 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=100 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=99 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69
|
-210 microns
Standard Deviation 151
|
-135 microns
Standard Deviation 152
|
-176 microns
Standard Deviation 151
|
SECONDARY outcome
Timeframe: baseline to 1-yearPopulation: In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.
All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center. Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes.
Outcome measures
| Measure |
Aflibercept
n=104 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=103 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=102 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69
|
-129 microns
Standard Deviation 110
|
-67 microns
Standard Deviation 65
|
-119 microns
Standard Deviation 109
|
SECONDARY outcome
Timeframe: Baseline to 1-yearPopulation: In addition to participants missing the 1-year visit, 46 in the aflibercept group, 53 in the bevacizumab group, and 44 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.
Baseline volume values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 459 scans. One-year volume values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 472 scans. When calculating change in volume, measurements taken on the same machine at both visits were not converted, because the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in volume was calculated after converting either the baseline and/or follow-up value from Spectralis or Cirrus to a Stratus equivalent value in 17 eyes.
Outcome measures
| Measure |
Aflibercept
n=162 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=153 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=162 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Overall Change in Retinal Volume
|
-1.7 mm^3
Standard Deviation 1.6
|
-1.0 mm^3
Standard Deviation 1.2
|
-1.7 mm^3
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline to 1-yearPopulation: Seven study eyes received 1 injection and 2 eyes received 2 injections of 0.5 mg of ranibizumab prior to the FDA approving a 0.3 mg dosage of ranibizumab for diabetic macular edema treatment.
Only includes participants that completed the 1 year visit
Outcome measures
| Measure |
Aflibercept
n=208 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=206 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=206 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Total Number of Injections Prior to 1 Year
|
9.2 Injections
Standard Deviation 2.0
|
9.7 Injections
Standard Deviation 2.3
|
9.4 Injections
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: between 24 weeks and 1 yearOnly includes participants that completed the 1 year visit.
Outcome measures
| Measure |
Aflibercept
n=208 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=206 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=206 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Total Number of Laser Treatments
0
|
132 participants
|
91 participants
|
111 participants
|
|
Total Number of Laser Treatments
1
|
57 participants
|
85 participants
|
77 participants
|
|
Total Number of Laser Treatments
2
|
19 participants
|
30 participants
|
18 participants
|
SECONDARY outcome
Timeframe: Baseline to 1-yearOutcome measures
| Measure |
Aflibercept
n=208 Participants
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=206 Participants
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Ranibizumab
n=206 Participants
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Eyes Receiving 1 or More Alternative Treatments for DME Other Than Laser
|
2 Eyes
|
4 Eyes
|
1 Eyes
|
Adverse Events
Ranibizumab
Serious events: 57 serious events
Other events: 144 other events
Deaths: 0 deaths
Aflibercept
Serious events: 61 serious events
Other events: 152 other events
Deaths: 0 deaths
Bevacizumab
Serious events: 46 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab
n=218 participants at risk
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Aflibercept
n=224 participants at risk
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=218 participants at risk
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
anaemia
|
0.46%
1/218
|
1.3%
3/224
|
0.00%
0/218
|
|
Blood and lymphatic system disorders
anaemia of chronic disease
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Cardiac disorders
arrhythmia
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Cardiac disorders
arteriosclerosis coronary artery
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.92%
2/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/218
|
0.45%
1/224
|
0.46%
1/218
|
|
Cardiac disorders
cardiac failure
|
0.92%
2/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Cardiac disorders
cardiac failure congestive
|
2.8%
6/218
|
0.45%
1/224
|
1.4%
3/218
|
|
Cardiac disorders
cardiomegaly
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Cardiac disorders
coronary artery disease
|
1.4%
3/218
|
0.89%
2/224
|
0.92%
2/218
|
|
Cardiac disorders
diastolic dysfunction
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Cardiac disorders
hypertensive heart disease
|
0.46%
1/218
|
0.89%
2/224
|
0.00%
0/218
|
|
Cardiac disorders
myocardial infarction
|
1.4%
3/218
|
1.3%
3/224
|
0.46%
1/218
|
|
Cardiac disorders
palpitations
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Cardiac disorders
pericardial effusion
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Cardiac disorders
ventricular tachycardia
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Endocrine disorders
Diabetic ketoacidosis
|
0.46%
1/218
|
0.89%
2/224
|
0.46%
1/218
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Endocrine disorders
Hyperglycaemia
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Endocrine disorders
Hypoglycaemia
|
0.46%
1/218
|
0.89%
2/224
|
0.00%
0/218
|
|
Eye disorders
Cataract
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Eye disorders
Endophthalmitis
|
0.46%
1/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Eye disorders
Glaucoma
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Abdominal pain
|
0.46%
1/218
|
0.00%
0/224
|
1.4%
3/218
|
|
Gastrointestinal disorders
Clostridium difficile colitis
|
0.46%
1/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Colon cancer
|
0.46%
1/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.46%
1/218
|
0.89%
2/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Gastric cancer stage I
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/218
|
0.00%
0/224
|
0.92%
2/218
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.46%
1/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Gastrointestinal stoma complication
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.4%
3/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/218
|
0.45%
1/224
|
0.46%
1/218
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Gastrointestinal disorders
Vomiting
|
0.46%
1/218
|
2.2%
5/224
|
1.8%
4/218
|
|
General disorders
Chest pain
|
0.92%
2/218
|
1.3%
3/224
|
1.8%
4/218
|
|
General disorders
Death
|
0.00%
0/218
|
0.45%
1/224
|
0.46%
1/218
|
|
General disorders
Device related infection
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
General disorders
Fatigue
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
General disorders
Oedema peripheral
|
0.00%
0/218
|
0.45%
1/224
|
0.46%
1/218
|
|
General disorders
Pain
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
General disorders
Pyrexia
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Immune system disorders
Drug hypersensitivity
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Infections and infestations
Abscess
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Infections and infestations
Escherichia infection
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Infections and infestations
Infection
|
0.46%
1/218
|
0.45%
1/224
|
0.92%
2/218
|
|
Infections and infestations
Influenza
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Infections and infestations
Localised infection
|
1.4%
3/218
|
0.89%
2/224
|
0.92%
2/218
|
|
Infections and infestations
Sepsis
|
0.46%
1/218
|
1.3%
3/224
|
0.46%
1/218
|
|
Infections and infestations
Septic shock
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Infections and infestations
Staphylococcal infection
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/218
|
0.45%
1/224
|
0.46%
1/218
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Injury, poisoning and procedural complications
Subgaleal haematoma
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Investigations
International normalised ratio increased
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Metabolism and nutrition disorders
Dehydration
|
0.92%
2/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.92%
2/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Inclusion body myositis
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/218
|
0.00%
0/224
|
0.92%
2/218
|
|
Musculoskeletal and connective tissue disorders
Lower limb fracture
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Multiple fractures
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.46%
1/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/218
|
0.00%
0/224
|
0.92%
2/218
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.92%
2/218
|
0.89%
2/224
|
0.92%
2/218
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Pelvic fracture
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Musculoskeletal and connective tissue disorders
Upper limb fracture
|
0.46%
1/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Wrist fracture
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polyp
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.92%
2/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Convulsion
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dizziness
|
0.92%
2/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysarthria
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Encephalopathy
|
0.46%
1/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypoaesthesia
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuropathy peripheral
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Presyncope
|
0.00%
0/218
|
0.45%
1/224
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Somnolence
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Syncope
|
0.92%
2/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
VIIth nerve paralysis
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vestibular neuronitis
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Psychiatric disorders
Bipolar disorder
|
0.92%
2/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Psychiatric disorders
Psychotic disorder
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Renal and urinary disorders
Bladder prolapse
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Renal and urinary disorders
Renal failure
|
4.1%
9/218
|
1.8%
4/224
|
2.8%
6/218
|
|
Renal and urinary disorders
Renal failure acute
|
0.46%
1/218
|
0.45%
1/224
|
0.46%
1/218
|
|
Renal and urinary disorders
Renal failure chronic
|
2.3%
5/218
|
2.2%
5/224
|
0.00%
0/218
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/218
|
1.3%
3/224
|
0.46%
1/218
|
|
Reproductive system and breast disorders
Breast cancer
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
3/218
|
0.89%
2/224
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/218
|
0.45%
1/224
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Cardio-respiratory arrest
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/218
|
0.89%
2/224
|
0.00%
0/218
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.46%
1/218
|
0.89%
2/224
|
0.46%
1/218
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.8%
6/218
|
1.3%
3/224
|
1.8%
4/218
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.92%
2/218
|
0.89%
2/224
|
2.8%
6/218
|
|
Skin and subcutaneous tissue disorders
Cellulitis gangrenous
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
1.4%
3/218
|
0.45%
1/224
|
0.92%
2/218
|
|
Skin and subcutaneous tissue disorders
Furuncle
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Surgical and medical procedures
Foot amputation
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/218
|
0.00%
0/224
|
0.92%
2/218
|
|
Surgical and medical procedures
Surgery
|
0.92%
2/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Vascular disorders
Arteriovenous fistula
|
0.46%
1/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Vascular disorders
Basilar artery occlusion
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Vascular disorders
Cerebrovascular accident
|
1.4%
3/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Vascular disorders
Haematoma
|
0.00%
0/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Vascular disorders
Haemorrhagic stroke
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Vascular disorders
Hypertension
|
1.4%
3/218
|
0.89%
2/224
|
0.92%
2/218
|
|
Vascular disorders
Hypotension
|
0.46%
1/218
|
0.45%
1/224
|
0.00%
0/218
|
|
Vascular disorders
Ischaemic stroke
|
1.4%
3/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/218
|
0.89%
2/224
|
0.00%
0/218
|
|
Vascular disorders
Transient ischaemic attack
|
0.92%
2/218
|
0.00%
0/224
|
0.46%
1/218
|
|
Vascular disorders
Venous insufficiency
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
|
Vascular disorders
Venous stenosis
|
0.46%
1/218
|
0.00%
0/224
|
0.00%
0/218
|
Other adverse events
| Measure |
Ranibizumab
n=218 participants at risk
0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
Aflibercept
n=224 participants at risk
2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
|
Bevacizumab
n=218 participants at risk
1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
|
|---|---|---|---|
|
Eye disorders
Cataract
|
6.4%
14/218 • Number of events 16
|
6.2%
14/224 • Number of events 17
|
5.0%
11/218 • Number of events 14
|
|
Eye disorders
Conjunctival haemorrhage
|
11.5%
25/218 • Number of events 55
|
13.4%
30/224 • Number of events 67
|
19.3%
42/218 • Number of events 83
|
|
Eye disorders
Dry eye
|
6.0%
13/218 • Number of events 18
|
6.2%
14/224 • Number of events 23
|
4.1%
9/218 • Number of events 15
|
|
Eye disorders
Eye irritation
|
6.4%
14/218 • Number of events 24
|
5.8%
13/224 • Number of events 28
|
7.3%
16/218 • Number of events 27
|
|
Eye disorders
Eye pain
|
9.6%
21/218 • Number of events 27
|
12.1%
27/224 • Number of events 45
|
17.0%
37/218 • Number of events 50
|
|
Eye disorders
Eye pruritus
|
5.0%
11/218 • Number of events 20
|
5.4%
12/224 • Number of events 15
|
4.6%
10/218 • Number of events 13
|
|
Eye disorders
Lacrimation increased
|
5.5%
12/218 • Number of events 14
|
7.1%
16/224 • Number of events 22
|
3.2%
7/218 • Number of events 10
|
|
Eye disorders
Vision blurred
|
20.6%
45/218 • Number of events 77
|
17.0%
38/224 • Number of events 55
|
17.9%
39/218 • Number of events 53
|
|
Eye disorders
Visual acuity reduced
|
7.8%
17/218 • Number of events 25
|
8.0%
18/224 • Number of events 24
|
10.1%
22/218 • Number of events 27
|
|
Eye disorders
Vitreous floaters
|
17.0%
37/218 • Number of events 62
|
18.3%
41/224 • Number of events 54
|
24.3%
53/218 • Number of events 70
|
|
Eye disorders
Vitreous haemorrhage
|
6.0%
13/218 • Number of events 15
|
6.2%
14/224 • Number of events 17
|
8.3%
18/218 • Number of events 25
|
|
Nervous system disorders
Headache
|
6.9%
15/218 • Number of events 15
|
6.7%
15/224 • Number of events 19
|
6.9%
15/218 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
7.3%
16/218 • Number of events 17
|
12.1%
27/224 • Number of events 31
|
9.2%
20/218 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
6.0%
13/218 • Number of events 20
|
5.4%
12/224 • Number of events 13
|
3.7%
8/218 • Number of events 8
|
|
Vascular disorders
Hypertension
|
10.6%
23/218 • Number of events 24
|
10.7%
24/224 • Number of events 26
|
6.9%
15/218 • Number of events 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Trial results can not be discussed until they have been made available to the public.
- Publication restrictions are in place
Restriction type: OTHER