Trial Outcomes & Findings for A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion (NCT NCT01277302)
NCT ID: NCT01277302
Last Updated: 2014-04-23
Results Overview
BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by time in a longitudinal model was used to assess whether there was a difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 randomized treatment groups, Monthly and PRN.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
202 participants
Primary outcome timeframe
Baseline to Month 15
Results posted on
2014-04-23
Participant Flow
Participant milestones
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
7-Month Fixed Treatment Period
STARTED
|
85
|
86
|
31
|
|
7-Month Fixed Treatment Period
COMPLETED
|
85
|
86
|
19
|
|
7-Month Fixed Treatment Period
NOT COMPLETED
|
0
|
0
|
12
|
|
8-Month Alternate Dose Regimen Period
STARTED
|
85
|
86
|
19
|
|
8-Month Alternate Dose Regimen Period
COMPLETED
|
80
|
82
|
13
|
|
8-Month Alternate Dose Regimen Period
NOT COMPLETED
|
5
|
4
|
6
|
Reasons for withdrawal
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
7-Month Fixed Treatment Period
Subject Decision to Withdraw
|
0
|
0
|
8
|
|
7-Month Fixed Treatment Period
Lost to Follow-up
|
0
|
0
|
2
|
|
7-Month Fixed Treatment Period
Subject Required Other Drug Therapy
|
0
|
0
|
1
|
|
7-Month Fixed Treatment Period
Subject Non-compliance
|
0
|
0
|
1
|
|
8-Month Alternate Dose Regimen Period
Death
|
0
|
1
|
0
|
|
8-Month Alternate Dose Regimen Period
Lost to Follow-up
|
1
|
1
|
3
|
|
8-Month Alternate Dose Regimen Period
Subject Decision to Withdraw
|
3
|
0
|
1
|
|
8-Month Alternate Dose Regimen Period
Subject Non-compliance
|
0
|
2
|
1
|
|
8-Month Alternate Dose Regimen Period
Relocation
|
1
|
0
|
1
|
Baseline Characteristics
A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
66.3 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 15Population: Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the Monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.
BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by time in a longitudinal model was used to assess whether there was a difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 randomized treatment groups, Monthly and PRN.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15
Month 7 (n=85, 86)
|
17.5 Letters
Standard Deviation 12.6
|
19.7 Letters
Standard Deviation 12.6
|
—
|
|
Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15
Month 15 (n=80, 82)
|
18.7 Letters
Standard Deviation 14.1
|
21.0 Letters
Standard Deviation 14.1
|
—
|
SECONDARY outcome
Timeframe: Month 7 through Month 15Population: Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.
BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. This outcome measure is not relevant for subjects in the non-randomized group because they never met the VA-OCT stability criteria.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month
Month 8 (n=53, 53)
|
0.4 Letters
Standard Deviation 3.2
|
-3.3 Letters
Standard Deviation 11.3
|
—
|
|
Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month
Month 9 (n=49, 40)
|
0.5 Letters
Standard Deviation 4.0
|
-2.9 Letters
Standard Deviation 8.6
|
—
|
|
Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month
Month 10 (n=52, 31)
|
0.2 Letters
Standard Deviation 3.4
|
-0.5 Letters
Standard Deviation 4.2
|
—
|
|
Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month
Month 11 (n=54, 40)
|
-0.6 Letters
Standard Deviation 3.7
|
0.4 Letters
Standard Deviation 4.4
|
—
|
|
Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month
Month 12 (n=46, 44)
|
-0.2 Letters
Standard Deviation 3.2
|
-1.6 Letters
Standard Deviation 4.4
|
—
|
|
Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month
Month 13 (n=50, 41)
|
0.0 Letters
Standard Deviation 3.5
|
-0.5 Letters
Standard Deviation 5.2
|
—
|
|
Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month
Month 14 (n=58, 48)
|
-0.1 Letters
Standard Deviation 3.6
|
-2.2 Letters
Standard Deviation 6.1
|
—
|
|
Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month
Month 15 (n=56, 42)
|
0.0 Letters
Standard Deviation 4.4
|
-0.4 Letters
Standard Deviation 4.0
|
—
|
SECONDARY outcome
Timeframe: Month 7 to Month 15Population: Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.
BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline
Month 7 (n=85, 86, 17)
|
62.4 Percentage of participants
Interval 52.1 to 72.7
|
67.4 Percentage of participants
Interval 57.5 to 77.3
|
41.2 Percentage of participants
Interval 17.8 to 64.6
|
|
Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline
Month 15 (n=80, 82, 13)
|
66.3 Percentage of participants
Interval 55.9 to 76.6
|
70.7 Percentage of participants
Interval 60.9 to 80.6
|
46.2 Percentage of participants
Interval 19.1 to 73.3
|
SECONDARY outcome
Timeframe: Month 7 to Month 15Population: Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.
VA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better
Month 7 (n=85, 86, 17)
|
72.9 Percentage of participants
Interval 63.5 to 82.4
|
76.7 Percentage of participants
Interval 67.8 to 85.7
|
47.1 Percentage of participants
Interval 23.3 to 70.8
|
|
Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better
Month 15 (n=80, 82, 13)
|
71.3 Percentage of participants
Interval 61.3 to 81.2
|
76.8 Percentage of participants
Interval 67.7 to 86.0
|
46.2 Percentage of participants
Interval 19.1 to 73.3
|
SECONDARY outcome
Timeframe: Month 1 to Month 15Population: Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.
BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score
Month 1 (n=85, 86, 29)
|
12.2 Letters
Standard Deviation 10.3
|
11.2 Letters
Standard Deviation 10.4
|
10.7 Letters
Standard Deviation 14.0
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score
Month 7 (n=85, 86, 17)
|
17.5 Letters
Standard Deviation 12.6
|
19.7 Letters
Standard Deviation 12.6
|
14.7 Letters
Standard Deviation 12.0
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score
Month 15 (n=80, 82, 13)
|
18.7 Letters
Standard Deviation 14.1
|
21.0 Letters
Standard Deviation 14.1
|
14.5 Letters
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Month 7 to Month 15Population: Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.
BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline
Month 7 (n=85, 86, 17)
|
98.8 Percentage of participants
Interval 96.5 to 100.0
|
98.8 Percentage of participants
Interval 96.6 to 100.0
|
100.0 Percentage of participants
A 95% confidence interval cannot be calculated for the observed percentage of 100%.
|
|
Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline
Month 15 (n=80, 82, 13)
|
98.8 Percentage of participants
Interval 96.3 to 100.0
|
98.8 Percentage of participants
Interval 96.4 to 100.0
|
100.0 Percentage of participants
A 95% confidence interval cannot be calculated for the observed percentage of 100%.
|
SECONDARY outcome
Timeframe: Month 7 to Month 15Population: Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.
Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness \> 300 µm at baseline.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Percentage of Participants With a Central Foveal Thickness of ≤ 300 µm
Month 7 (n=85, 86, 17)
|
88.2 Percentage of participants
Interval 81.4 to 95.1
|
94.2 Percentage of participants
Interval 89.2 to 99.1
|
52.9 Percentage of participants
Interval 29.2 to 76.7
|
|
Percentage of Participants With a Central Foveal Thickness of ≤ 300 µm
Month 15 (n=80, 82, 13)
|
92.5 Percentage of participants
Interval 86.7 to 98.3
|
85.4 Percentage of participants
Interval 77.7 to 93.0
|
38.5 Percentage of participants
Interval 12.0 to 64.9
|
SECONDARY outcome
Timeframe: Month 1 to Month 15Population: Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.
Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness \> 300 µm at baseline. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Mean Change From Baseline in Central Foveal Thickness
Month 1 (n=85, 86, 29)
|
-243.0 µm
Standard Deviation 172.5
|
-214.9 µm
Standard Deviation 166.7
|
-157.9 µm
Standard Deviation 181.8
|
|
Mean Change From Baseline in Central Foveal Thickness
Month 7 (n=85, 86, 17)
|
-279.7 µm
Standard Deviation 167.4
|
-265.2 µm
Standard Deviation 185.9
|
-113.9 µm
Standard Deviation 184.9
|
|
Mean Change From Baseline in Central Foveal Thickness
Month 15 (n=80, 82, 13)
|
-289.9 µm
Standard Deviation 177.2
|
-247.8 µm
Standard Deviation 207.5
|
-93.2 µm
Standard Deviation 225.2
|
SECONDARY outcome
Timeframe: Month 7 to Month 15Population: Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.
The presence of intraretinal edema was defined as the presence of subretinal fluid, cystoid spaces, or central retinal thickness ≥ 300 µm as evaluated in spectral-domain optical coherence tomography images by the Digital Angiography Reading Center, the central reading center. At baseline, all participants in the Monthly and PRN groups had presence of edema.
Outcome measures
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 Participants
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Percentage of Participants With Intraretinal Edema
Month 7 (n=85, 86, 17)
|
31.8 Percentage of participants
Interval 21.9 to 41.7
|
30.2 Percentage of participants
Interval 20.5 to 39.9
|
100.0 Percentage of participants
A 95% confidence interval cannot be calculated for the observed percentage of 100%.
|
|
Percentage of Participants With Intraretinal Edema
Month 15 (n=80, 82, 13)
|
25.0 Percentage of participants
Interval 15.5 to 34.5
|
32.9 Percentage of participants
Interval 22.8 to 43.1
|
84.6 Percentage of participants
Interval 65.0 to 100.0
|
Adverse Events
Ranibizumab 0.5 mg Monthly - Randomized Subjects
Serious events: 12 serious events
Other events: 70 other events
Deaths: 0 deaths
Ranibizumab 0.5 mg PRN - Randomized Subjects
Serious events: 14 serious events
Other events: 61 other events
Deaths: 0 deaths
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
Serious events: 11 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 participants at risk
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 participants at risk
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 participants at risk
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Cardiac disorders
Sick sinus syndrome
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
General disorders
Chest pain
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
General disorders
Death
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
General disorders
Non-cardia chest pain
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
General disorders
Pain
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lymph node neoplasm
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Nervous system disorders
Dementia
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Macular hole
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Macular oedema
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
Other adverse events
| Measure |
Ranibizumab 0.5 mg Monthly - Randomized Subjects
n=85 participants at risk
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg PRN - Randomized Subjects
n=86 participants at risk
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
|
Ranibizumab 0.5 mg Monthly - Non-randomized Subjects
n=31 participants at risk
Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
2.3%
2/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Infections and infestations
Bronchitis
|
4.7%
4/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.5%
3/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
10/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
8.1%
7/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Infections and infestations
Sinusitis
|
3.5%
3/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
7.0%
6/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
3/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.5%
3/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
9.7%
3/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Infections and infestations
Urinary tract infection
|
2.4%
2/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
7.0%
6/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Investigations
Blood pressure increased
|
2.4%
2/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
2/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
5.8%
5/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.2%
7/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
5.8%
5/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Nervous system disorders
Headache
|
2.4%
2/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Vascular disorders
Hypertension
|
15.3%
13/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
9.3%
8/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Cataract
|
9.4%
8/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
5.8%
5/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Cataract cortical
|
4.7%
4/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
5.8%
5/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
32.9%
28/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
26.7%
23/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
29.0%
9/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Dry eye
|
3.5%
3/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
2.3%
2/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Eye irritation
|
7.1%
6/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
5.8%
5/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Eye pain
|
9.4%
8/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
16.3%
14/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
12.9%
4/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Eye pruritus
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
4.7%
4/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Macular fibrosis
|
10.6%
9/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
5.8%
5/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Macular hole
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Macular oedema
|
2.4%
2/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
7.0%
6/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Retinal aneurysm
|
1.2%
1/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
5.8%
5/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Retinal depigmentation
|
2.4%
2/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
6.5%
2/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Retinal disorder
|
8.2%
7/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
1.2%
1/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Retinal exudates
|
15.3%
13/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
14.0%
12/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
9.7%
3/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Retinal haemorrhage
|
4.7%
4/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
7.0%
6/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Retinal vascular disorder
|
3.5%
3/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
5.8%
5/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Vitreous adhesions
|
0.00%
0/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
0.00%
0/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
9.7%
3/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Vitreous detachment
|
8.2%
7/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
2.3%
2/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Eye disorders
Vitreous floaters
|
4.7%
4/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
7.0%
6/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
|
Investigations
Intraocular pressure increased
|
3.5%
3/85 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
9.3%
8/86 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
3.2%
1/31 • Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.
After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.
|
Additional Information
Medical Communications
Genentech, Inc.
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER