Trial Outcomes & Findings for Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration) (NCT NCT01775124)
NCT ID: NCT01775124
Last Updated: 2019-09-04
Results Overview
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
332 participants
Primary outcome timeframe
Month 3 to month 4 through Month 12
Results posted on
2019-09-04
Participant Flow
A total of 334 patients were randomized in this study. One patient was mis-randomized to ranibizumab 0.5 monthly group and another patient was discontinued due to AE. Neither patient received any treatment
Participant milestones
| Measure |
Ranibizumab 0.5 mg Monthly
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Core Period
STARTED
|
168
|
166
|
|
Core Period
Full Analysis Set
|
167
|
166
|
|
Core Period
Per Protocol Set
|
157
|
155
|
|
Core Period
Safety Set
|
166
|
166
|
|
Core Period
COMPLETED
|
157
|
156
|
|
Core Period
NOT COMPLETED
|
11
|
10
|
|
Extension Period
STARTED
|
157
|
156
|
|
Extension Period
COMPLETED
|
145
|
138
|
|
Extension Period
NOT COMPLETED
|
12
|
18
|
Reasons for withdrawal
| Measure |
Ranibizumab 0.5 mg Monthly
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Core Period
Disease Progression
|
0
|
1
|
|
Core Period
Physician Decision
|
1
|
1
|
|
Core Period
Death
|
0
|
1
|
|
Core Period
Administrative problems
|
1
|
0
|
|
Core Period
Withdrawal by Subject
|
4
|
2
|
|
Core Period
Adverse Event
|
5
|
5
|
|
Extension Period
Adverse Event
|
3
|
2
|
|
Extension Period
Physician Decision
|
0
|
2
|
|
Extension Period
Administrative problems
|
0
|
1
|
|
Extension Period
Lost to Follow-up
|
0
|
1
|
|
Extension Period
Withdrawal by Subject
|
9
|
12
|
Baseline Characteristics
Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)
Baseline characteristics by cohort
| Measure |
Ranibizumab 0.5 mg Monthly
n=167 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 Years
STANDARD_DEVIATION 8.43 • n=99 Participants
|
66.8 Years
STANDARD_DEVIATION 8.31 • n=107 Participants
|
66.2 Years
STANDARD_DEVIATION 8.38 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Month 3 to month 4 through Month 12Population: Full Analysis Set: Consisted of all patients to whom study treatment was assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=162 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=159 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12
|
3.3 Letters
Standard Deviation 5.61
|
1.7 Letters
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: Month 3 to month 4 through Month 24Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=162 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=159 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24
|
3.7 Letters
Standard Deviation 7.36
|
2.2 Letters
Standard Deviation 7.95
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=165 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24
Average Month 1 through month 24
|
11.0 Letters
Standard Deviation 10.28
|
8.9 Letters
Standard Deviation 11.95
|
|
Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24
Average Month 1 through month 12
|
10.1 Letters
Standard Deviation 9.37
|
8.1 Letters
Standard Deviation 10.95
|
SECONDARY outcome
Timeframe: Baseline to 24 monthsPopulation: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=165 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 2
|
6.8 letters
Standard Deviation 8.02
|
6.3 letters
Standard Deviation 9.94
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 6
|
10.7 letters
Standard Deviation 10.92
|
8.7 letters
Standard Deviation 12.33
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 7
|
11.4 letters
Standard Deviation 10.49
|
8.5 letters
Standard Deviation 13.01
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 12
|
12.3 letters
Standard Deviation 11.47
|
9.6 letters
Standard Deviation 13.06
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 13
|
12.2 letters
Standard Deviation 12.04
|
9.9 letters
Standard Deviation 12.98
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 15
|
12.2 letters
Standard Deviation 12.19
|
9.9 letters
Standard Deviation 13.56
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 16
|
12.3 letters
Standard Deviation 11.59
|
10.0 letters
Standard Deviation 13.64
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 17
|
12.1 letters
Standard Deviation 11.94
|
10.4 letters
Standard Deviation 13.78
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 19
|
12.1 letters
Standard Deviation 12.43
|
9.8 letters
Standard Deviation 14.54
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 1
|
4.3 letters
Standard Deviation 6.75
|
3.4 letters
Standard Deviation 8.74
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 3
|
8.0 letters
Standard Deviation 9.38
|
7.2 letters
Standard Deviation 11.48
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 4
|
9.3 letters
Standard Deviation 10.52
|
7.9 letters
Standard Deviation 11.67
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 5
|
9.9 letters
Standard Deviation 10.71
|
8.4 letters
Standard Deviation 11.66
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 8
|
11.3 letters
Standard Deviation 11.06
|
8.8 letters
Standard Deviation 12.53
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 9
|
11.8 letters
Standard Deviation 10.90
|
9.2 letters
Standard Deviation 12.83
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 10
|
12.4 letters
Standard Deviation 11.24
|
9.4 letters
Standard Deviation 12.84
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 11
|
12.5 letters
Standard Deviation 10.90
|
9.6 letters
Standard Deviation 12.89
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 14
|
12.1 letters
Standard Deviation 12.18
|
10.0 letters
Standard Deviation 13.29
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 18
|
11.8 letters
Standard Deviation 12.31
|
10.1 letters
Standard Deviation 13.25
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 20
|
12.1 letters
Standard Deviation 12.70
|
9.8 letters
Standard Deviation 14.74
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 21
|
11.9 letters
Standard Deviation 13.17
|
9.6 letters
Standard Deviation 14.73
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 22
|
11.3 letters
Standard Deviation 13.19
|
9.5 letters
Standard Deviation 15.26
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 23
|
11.5 letters
Standard Deviation 13.23
|
9.2 letters
Standard Deviation 15.13
|
|
Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time
Month 24
|
11.3 letters
Standard Deviation 13.72
|
9.3 letters
Standard Deviation 15.48
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Visual acuity (VA) was at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=165 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 12 Gain of >=15 letters
|
69 Patients
|
52 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 12 Gain of >=30 letters
|
7 Patients
|
11 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 13 Gain of >=5 letters
|
127 Patients
|
118 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 13 Gain of >=10 letters
|
96 Patients
|
92 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 1 Gain of >=15 letters
|
11 Patients
|
17 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 2 Gain of >=5 letters
|
98 Patients
|
95 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 2 Gain of >=10 letters
|
54 Patients
|
48 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 3 Gain of >=5 letters
|
107 Patients
|
100 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 3 Gain of >=15 letters
|
40 Patients
|
37 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 3 Gain of >=30 letters
|
1 Patients
|
4 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 4 Gain of >=10 letters
|
80 Patients
|
75 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 4 Gain of >=15 letters
|
53 Patients
|
46 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 5 Gain of >=15 letters
|
59 Patients
|
46 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 6 Gain of >=5 letters
|
124 Patients
|
108 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 7 Gain of >=30 letters
|
5 Patients
|
10 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 8 Gain of >=5 letters
|
129 Patients
|
110 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 8 Gain of >=10 letters
|
89 Patients
|
74 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 8 Gain of >=15 letters
|
66 Patients
|
54 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 8 Gain of >=30 letters
|
6 Patients
|
7 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 10 Gain of >=15 letters
|
74 Patients
|
53 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 10 Gain of >=30 letters
|
8 Patients
|
11 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 11 Gain of >=15 letters
|
78 Patients
|
56 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 13 Gain of >=30 letters
|
9 Patients
|
11 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 14 Gain of >=5 letters
|
124 Patients
|
117 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 16 Gain of >=30 letters
|
7 Patients
|
11 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 17 Gain of >=5 letters
|
119 Patients
|
116 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 17 Gain of >=30 letters
|
5 Patients
|
12 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 18 Gain of >=5 letters
|
121 Patients
|
117 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 18 Gain of >=30 letters
|
6 Patients
|
13 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 19 Gain of >=5 letters
|
121 Patients
|
115 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 20 Gain of >=15 letters
|
72 Patients
|
63 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 20 Gain of >=30 letters
|
10 Patients
|
13 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 22 Gain of >=10 letters
|
92 Patients
|
88 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 22 Gain of >=15 letters
|
69 Patients
|
64 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 23 Gain of >=5 letters
|
119 Patients
|
115 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 23 Gain of >=10 letters
|
93 Patients
|
85 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 24 Gain of >=10 letters
|
95 Patients
|
83 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 11 Gain of >=10 letters
|
97 Patients
|
77 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 11 Gain of >=30 letters
|
7 Patients
|
11 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 12 Gain of >=5 letters
|
129 Patients
|
114 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 12 Gain of >=10 letters
|
97 Patients
|
82 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 1 Gain of >=5 letters
|
75 Patients
|
65 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 1 Gain of >=10 letters
|
27 Patients
|
31 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 1 Gain of >=30 letters
|
1 Patients
|
1 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 2 Gain of >=15 letters
|
28 Patients
|
32 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 2 Gain of >=30 letters
|
1 Patients
|
1 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 3 Gain of >=10 letters
|
71 Patients
|
60 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 4 Gain of >=5 letters
|
115 Patients
|
100 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 4 Gain of >=30 letters
|
3 Patients
|
4 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 5 Gain of >=5 letters
|
114 Patients
|
109 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 5 Gain of >=10 letters
|
88 Patients
|
72 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 5 Gain of >=30 letters
|
4 Patients
|
5 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 6 Gain of >=10 letters
|
86 Patients
|
75 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 6 Gain of >=15 letters
|
60 Patients
|
44 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 6 Gain of >=30 letters
|
6 Patients
|
9 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 7 Gain of >=5 letters
|
127 Patients
|
114 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 7 Gain of >=10 letters
|
89 Patients
|
70 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 7 Gain of >=15 letters
|
63 Patients
|
50 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 9 Gain of >=5 letters
|
126 Patients
|
107 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 9 Gain of >=10 letters
|
95 Patients
|
78 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 9 Gain of >=15 letters
|
69 Patients
|
57 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 9 Gain of >=30 letters
|
6 Patients
|
11 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 10 Gain of >=5 letters
|
128 Patients
|
116 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 10 Gain of >=10 letters
|
95 Patients
|
75 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 11 Gain of >=5 letters
|
130 Patients
|
115 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 13 Gain of >=15 letters
|
67 Patients
|
56 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 14 Gain of >=10 letters
|
100 Patients
|
88 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 14 Gain of >=15 letters
|
70 Patients
|
65 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 14 Gain of >=30 letters
|
9 Patients
|
13 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 15 Gain of >=5 letters
|
126 Patients
|
112 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 15 Gain of >=10 letters
|
104 Patients
|
84 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 15 Gain of >=15 letters
|
68 Patients
|
62 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 15 Gain of >=30 letters
|
8 Patients
|
13 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 16 Gain of >=5 letters
|
126 Patients
|
114 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 16 Gain of >=10 letters
|
101 Patients
|
87 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 16 Gain of >=15 letters
|
71 Patients
|
62 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 17 Gain of >=10 letters
|
102 Patients
|
87 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 17 Gain of >=15 letters
|
71 Patients
|
62 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 18 Gain of >=10 letters
|
101 Patients
|
87 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 18 Gain of >=15 letters
|
69 Patients
|
61 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 19 Gain of >=10 letters
|
94 Patients
|
88 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 19 Gain of >=15 letters
|
75 Patients
|
62 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 19 Gain of >=30 letters
|
9 Patients
|
11 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 20 Gain of >=5 letters
|
116 Patients
|
116 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 20 Gain of >=10 letters
|
98 Patients
|
85 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 21 Gain of >=5 letters
|
120 Patients
|
117 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 21 Gain of >=10 letters
|
96 Patients
|
81 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 21 Gain of >=15 letters
|
76 Patients
|
61 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 21 Gain of >=30 letters
|
11 Patients
|
12 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 22 Gain of >=5 letters
|
116 Patients
|
114 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 22 Gain of >=30 letters
|
14 Patients
|
13 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 23 Gain of >=15 letters
|
72 Patients
|
62 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 23 Gain of >=30 letters
|
8 Patients
|
13 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 24 Gain of >=5 letters
|
114 Patients
|
116 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 24 Gain of >=15 letters
|
73 Patients
|
60 Patients
|
|
Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24
Month 24 Gain of >=30 letters
|
11 Patients
|
13 Patients
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=165 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 6, Loss of < 15 letters
|
162 Patients
|
160 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 7, Loss of < 15 letters
|
162 Patients
|
158 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 1, Loss of < 15 letters
|
164 Patients
|
163 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 2, Loss of < 15 letters
|
163 Patients
|
162 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 3, Loss of < 15 letters
|
160 Patients
|
162 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 4, Loss of < 15 letters
|
161 Patients
|
162 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 5, Loss of < 15 letters
|
160 Patients
|
160 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 8, Loss of < 15 letters
|
162 Patients
|
159 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 9, Loss of < 15 letters
|
163 Patients
|
159 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 10, Loss of < 15 letters
|
162 Patients
|
161 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 11, Loss of < 15 letters
|
162 Patients
|
161 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 12, Loss of < 15 letters
|
162 Patients
|
160 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 13, Loss of < 15 letters
|
162 Patients
|
157 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 14, Loss of < 15 letters
|
161 Patients
|
158 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 15, Loss of < 15 letters
|
162 Patients
|
159 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 16, Loss of < 15 letters
|
163 Patients
|
159 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 17, Loss of < 15 letters
|
161 Patients
|
157 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 18, Loss of < 15 letters
|
159 Patients
|
157 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 19, Loss of < 15 letters
|
162 Patients
|
155 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 20, Loss of < 15 letters
|
161 Patients
|
155 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 21, Loss of < 15 letters
|
157 Patients
|
155 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 22, Loss of < 15 letters
|
160 Patients
|
154 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 23, Loss of < 15 letters
|
158 Patients
|
153 Patients
|
|
Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time
Month 24, Loss of < 15 letters
|
158 Patients
|
153 Patients
|
SECONDARY outcome
Timeframe: Month 12 and 24Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for Month 12 and Month 24 whether a patient had a VA score of 73 or more letters
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=165 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More
Month 12>=73 letters
|
68 Patients
|
56 Patients
|
|
Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More
Month 24>=73 letters
|
63 Patients
|
59 Patients
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (LOCF)= last observation carried forward
Optical coherence tomography(OCT) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=163 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 1
|
-112.8 microns
Standard Deviation 117.95
|
-108.7 microns
Standard Deviation 124.93
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 2
|
-141.1 microns
Standard Deviation 126.44
|
-130.4 microns
Standard Deviation 145.58
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 3
|
-141.3 microns
Standard Deviation 127.47
|
-141.2 microns
Standard Deviation 161.88
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 4
|
-150.4 microns
Standard Deviation 131.71
|
-134.5 microns
Standard Deviation 158.88
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 5
|
-155.2 microns
Standard Deviation 134.58
|
-131.5 microns
Standard Deviation 155.98
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 6
|
-158.6 microns
Standard Deviation 135.37
|
-138.3 microns
Standard Deviation 159.07
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 7
|
-156.9 microns
Standard Deviation 136.61
|
-137.9 microns
Standard Deviation 165.24
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 8
|
-165.4 microns
Standard Deviation 135.59
|
-142.2 microns
Standard Deviation 165.76
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 9
|
-165.1 microns
Standard Deviation 136.04
|
-143.3 microns
Standard Deviation 176.68
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 10
|
-165.9 microns
Standard Deviation 136.03
|
-152.5 microns
Standard Deviation 177.11
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 11
|
-166.6 microns
Standard Deviation 140.62
|
-152.5 microns
Standard Deviation 175.56
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 12
|
-166.5 microns
Standard Deviation 143.85
|
-155.7 microns
Standard Deviation 173.19
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 13
|
-160.3 microns
Standard Deviation 142.02
|
-151.4 microns
Standard Deviation 168.89
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 14
|
-159.9 microns
Standard Deviation 144.14
|
-153.2 microns
Standard Deviation 167.81
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 15
|
-156.9 microns
Standard Deviation 152.33
|
-158.1 microns
Standard Deviation 169.56
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 16
|
-155.9 microns
Standard Deviation 154.82
|
-158.1 microns
Standard Deviation 173.23
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 17
|
-161.8 microns
Standard Deviation 155.18
|
-156.8 microns
Standard Deviation 167.89
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 18
|
-159.5 microns
Standard Deviation 159.78
|
-156.7 microns
Standard Deviation 174.88
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 19
|
-158.5 microns
Standard Deviation 163.82
|
-154.8 microns
Standard Deviation 177.49
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 20
|
-157.6 microns
Standard Deviation 161.04
|
-152.1 microns
Standard Deviation 173.30
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 21
|
-155.2 microns
Standard Deviation 160.03
|
-151.9 microns
Standard Deviation 171.95
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 22
|
-156.8 microns
Standard Deviation 161.35
|
-146.5 microns
Standard Deviation 176.83
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 23
|
-159.4 microns
Standard Deviation 163.58
|
-148.3 microns
Standard Deviation 185.62
|
|
Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24
Month 24
|
-167.7 microns
Standard Deviation 163.12
|
-153.2 microns
Standard Deviation 178.22
|
SECONDARY outcome
Timeframe: up to month 24Population: Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment
This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=166 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24
First treatment free interval (n=99,144)
|
2.9 Months
Standard Deviation 2.38
|
3.7 Months
Standard Deviation 4.67
|
|
Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24
Second treatment free interval (n=49,112)
|
2.1 Months
Standard Deviation 1.51
|
3.3 Months
Standard Deviation 3.48
|
|
Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24
Third treatment free interval (n=12,78)
|
1.5 Months
Standard Deviation 0.52
|
3.0 Months
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: prior to month 12Population: Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment
This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=166 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12
First treatment free interval (n=127)
|
2.7 Months
Standard Deviation 2.22
|
—
|
|
Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12
Second treatment free interval (n=73)
|
2.0 Months
Standard Deviation 1.29
|
—
|
|
Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12
Third treatment free interval (n=19)
|
1.3 Months
Standard Deviation 0.67
|
—
|
SECONDARY outcome
Timeframe: Prior to month 12Population: Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=166 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Duration of Active Treatment Phase Prior to Month 12
|
10.5 Months
Standard Deviation 1.86
|
9.1 Months
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: up to month 24Population: Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly
n=166 Participants
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 Participants
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Duration of Active Treatment Phase up to Month 24
|
18.0 Months
Standard Deviation 5.99
|
17.1 Months
Standard Deviation 6.90
|
Adverse Events
Ranibizumab 0.5 mg Monthly
Serious events: 24 serious events
Other events: 107 other events
Deaths: 0 deaths
Ranibizumab 0.5 mg PRN
Serious events: 24 serious events
Other events: 87 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab 0.5 mg Monthly
n=166 participants at risk
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 participants at risk
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Cardiac disorders
Cardiac discomfort
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Cataract
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Retinal detachment
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Cardiac disorders
Angina pectoris
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Pneumonia
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Tinea pedis
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Nervous system disorders
Cerebral infarction
|
2.4%
4/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
Other adverse events
| Measure |
Ranibizumab 0.5 mg Monthly
n=166 participants at risk
Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by BCVA stabilization in the extension treatment period
|
Ranibizumab 0.5 mg PRN
n=166 participants at risk
PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 23 month treatment period
|
|---|---|---|
|
Cardiac disorders
Cardiac discomfort
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Age-related macular degeneration
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Cataract
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Choroidal neovascularisation
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Conjunctival haemorrhage
|
12.7%
21/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
7.2%
12/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Conjunctivitis allergic
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Dry eye
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Eye pain
|
2.4%
4/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Foreign body sensation in eyes
|
2.4%
4/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Glaucoma
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Lacrimation increased
|
2.4%
4/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Macular fibrosis
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Macular oedema
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
2.4%
4/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Ocular hyperaemia
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Retinal haemorrhage
|
3.0%
5/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
3.6%
6/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Retinal tear
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Vision blurred
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Visual acuity reduced
|
4.2%
7/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Eye disorders
Vitreous detachment
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
6/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Gastrointestinal disorders
Toothache
|
3.6%
6/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
3.0%
5/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
General disorders
Malaise
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
General disorders
Pyrexia
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Conjunctivitis
|
3.0%
5/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Herpes zoster
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
14.5%
24/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
10.8%
18/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.4%
14/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
4.2%
7/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Injury, poisoning and procedural complications
Animal bite
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Investigations
Blood glucose increased
|
6.0%
10/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
3.0%
5/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Investigations
Blood pressure increased
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Investigations
Blood uric acid increased
|
2.4%
4/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
3.0%
5/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Investigations
Intraocular pressure increased
|
3.0%
5/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
7.2%
12/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Investigations
Visual acuity tests abnormal
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.4%
4/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Nervous system disorders
Dizziness
|
3.0%
5/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
4.2%
7/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Nervous system disorders
Headache
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.60%
1/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.8%
3/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
8/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
4.2%
7/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.2%
2/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
0.00%
0/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
|
Vascular disorders
Hypertension
|
4.8%
8/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
4.8%
8/166
Safety Set: consisted of all patients who received at least one application of ranibizumab (the active study treatment) and had at least one post-Baseline safety assessment. A patient who had no AEs also constituted a safety assessment.
|
Additional Information
Study Director
Novartis
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER