Trial Outcomes & Findings for Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL) (NCT NCT00492284)
NCT ID: NCT00492284
Last Updated: 2011-06-02
Results Overview
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
162 participants
Primary outcome timeframe
Month 1 to Month 12
Results posted on
2011-06-02
Participant Flow
Participant milestones
| Measure |
1/4 Fluence Triple Therapy
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
39
|
43
|
41
|
|
Overall Study
COMPLETED
|
38
|
35
|
37
|
31
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
6
|
10
|
Reasons for withdrawal
| Measure |
1/4 Fluence Triple Therapy
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
3
|
1
|
|
Overall Study
Death
|
0
|
3
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
Baseline Characteristics
Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)
Baseline characteristics by cohort
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
78 years
STANDARD_DEVIATION 8 • n=5 Participants
|
78 years
STANDARD_DEVIATION 8 • n=7 Participants
|
79 years
STANDARD_DEVIATION 6 • n=5 Participants
|
79 years
STANDARD_DEVIATION 5 • n=4 Participants
|
79 years
STANDARD_DEVIATION 7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Lesion composition
Minimally classic
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
27 participants
n=21 Participants
|
|
Lesion composition
Occult no classic
|
10 participants
n=5 Participants
|
16 participants
n=7 Participants
|
20 participants
n=5 Participants
|
18 participants
n=4 Participants
|
64 participants
n=21 Participants
|
|
Lesion composition
Predominantly classic
|
23 participants
n=5 Participants
|
19 participants
n=7 Participants
|
14 participants
n=5 Participants
|
15 participants
n=4 Participants
|
71 participants
n=21 Participants
|
|
Central retinal thickness
|
318.3 micron
STANDARD_DEVIATION 95.9 • n=5 Participants
|
337.3 micron
STANDARD_DEVIATION 106.8 • n=7 Participants
|
337.3 micron
STANDARD_DEVIATION 121.4 • n=5 Participants
|
311.9 micron
STANDARD_DEVIATION 95.5 • n=4 Participants
|
326.3 micron
STANDARD_DEVIATION 105.4 • n=21 Participants
|
|
Lesion size (greatest linear dimension)
|
2778.8 micron
STANDARD_DEVIATION 1025.6 • n=5 Participants
|
2740.1 micron
STANDARD_DEVIATION 846.1 • n=7 Participants
|
2796.1 micron
STANDARD_DEVIATION 1122.8 • n=5 Participants
|
3118.4 micron
STANDARD_DEVIATION 1155.7 • n=4 Participants
|
2860.1 micron
STANDARD_DEVIATION 1049.4 • n=21 Participants
|
|
Study Eye Best-corrected Visual Acuity Score (ETDRS chart)
|
58.1 Letters read on ETDRS chart
STANDARD_DEVIATION 11.8 • n=5 Participants
|
55.6 Letters read on ETDRS chart
STANDARD_DEVIATION 11.2 • n=7 Participants
|
53.3 Letters read on ETDRS chart
STANDARD_DEVIATION 11.9 • n=5 Participants
|
56.0 Letters read on ETDRS chart
STANDARD_DEVIATION 13.1 • n=4 Participants
|
55.7 Letters read on ETDRS chart
STANDARD_DEVIATION 12.0 • n=21 Participants
|
PRIMARY outcome
Timeframe: Month 1 to Month 12Population: Intent-to-treat
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Outcome measures
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Mean Number of Retreatments (Day 0 Excluded)
|
3.97 number of retreatments
95% Confidence Interval 3.12 • Interval 2.96 to 4.98
|
3.00 number of retreatments
95% Confidence Interval 2.55 • Interval 2.17 to 3.83
|
4.05 number of retreatments
95% Confidence Interval 2.93 • Interval 3.15 to 4.95
|
5.39 number of retreatments
95% Confidence Interval 2.97 • Interval 4.45 to 6.33
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Intent-to-treat and last observation carried forward
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
Outcome measures
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)
|
3.6 Letters read on ETDRS chart
95% Confidence Interval 13.8 • Interval -0.9 to 8.1
|
6.8 Letters read on ETDRS chart
95% Confidence Interval 13.4 • Interval 2.4 to 11.1
|
5.0 Letters read on ETDRS chart
95% Confidence Interval 14.2 • Interval 0.6 to 9.3
|
6.5 Letters read on ETDRS chart
95% Confidence Interval 15.5 • Interval 1.7 to 11.4
|
SECONDARY outcome
Timeframe: Month 1 to Month 24Population: Intent-to-treat
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Outcome measures
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Mean Number of Retreatments (Day 0 Excluded)
|
5.92 number of retreatments
Interval 4.35 to 7.49
|
4.34 number of retreatments
Interval 3.09 to 5.6
|
5.92 number of retreatments
Interval 4.46 to 7.38
|
8.68 number of retreatments
Interval 6.74 to 10.62
|
SECONDARY outcome
Timeframe: Baseline to Month 24Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
Outcome measures
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Mean Change From Baseline in Study Eye Best-Corrected VA Score
|
-0.2 Letters read on ETDRS chart
Interval -5.7 to 5.4
|
1.1 Letters read on ETDRS chart
Interval -4.3 to 6.4
|
-0.3 Letters read on ETDRS chart
Interval -6.2 to 5.6
|
4.4 Letters read on ETDRS chart
Interval -1.5 to 10.2
|
SECONDARY outcome
Timeframe: Baseline to Month 12, Baseline to Month 24Population: Intent-to-treat and last observation carried forward
Outcome measures
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline
Baseline to Month 12
|
25.6 Percentage of participants
Interval 11.9 to 39.3
|
30.8 Percentage of participants
Interval 16.3 to 45.3
|
25.6 Percentage of participants
Interval 12.5 to 38.6
|
24.4 Percentage of participants
Interval 11.2 to 37.5
|
|
Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline
Baseline to Month 24
|
20.5 Percentage of participants
Interval 7.8 to 33.2
|
15.4 Percentage of participants
Interval 4.1 to 26.7
|
16.3 Percentage of participants
Interval 5.2 to 27.3
|
26.8 Percentage of participants
Interval 13.3 to 40.4
|
SECONDARY outcome
Timeframe: Baseline to Month 12, Baseline to Month 24Population: Intent-to-treat and last observation carried forward
Outcome measures
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline
Baseline to Month 12
|
64.1 Percentage of participants
Interval 49.0 to 79.2
|
82.1 Percentage of participants
Interval 70.0 to 94.1
|
69.8 Percentage of participants
Interval 56.0 to 83.5
|
70.7 Percentage of participants
Interval 56.8 to 84.7
|
|
Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline
Baseline to Month 24
|
61.5 Percentage of participants
Interval 46.3 to 76.8
|
66.7 Percentage of participants
Interval 51.9 to 81.5
|
60.5 Percentage of participants
Interval 45.9 to 75.1
|
70.7 Percentage of participants
Interval 56.8 to 84.7
|
SECONDARY outcome
Timeframe: Baseline to Month 12, Baseline to Month 24Population: Intent-to-treat and last observation carried forward
Outcome measures
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline
Baseline to Month 12
|
12.8 Percentage of participants
Interval 2.3 to 23.3
|
7.7 Percentage of participants
Interval 0.0 to 16.1
|
11.6 Percentage of participants
Interval 2.0 to 21.2
|
7.3 Percentage of participants
Interval 0.0 to 15.3
|
|
Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline
Baseline to Month 24
|
20.5 Percentage of participants
Interval 7.8 to 33.2
|
15.4 Percentage of participants
Interval 4.1 to 26.7
|
20.9 Percentage of participants
Interval 8.8 to 33.1
|
14.6 Percentage of participants
Interval 3.8 to 25.5
|
SECONDARY outcome
Timeframe: Baseline to Month 12, Baseline to Month 24Population: Intent-to-treat and last observation carried forward
Outcome measures
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Mean Change From Baseline in Central Retinal Thickness
Baseline to Month 12
|
-115.9 micron
Standard Deviation 97.4
|
-122.2 micron
Standard Deviation 104.8
|
-137.8 micron
Standard Deviation 122.3
|
-100.3 micron
Standard Deviation 90.1
|
|
Mean Change From Baseline in Central Retinal Thickness
Baseline to Month 24
|
-110.2 micron
Standard Deviation 93.6
|
-123.9 micron
Standard Deviation 97.1
|
-121.0 micron
Standard Deviation 126.6
|
-103.1 micron
Standard Deviation 99.1
|
SECONDARY outcome
Timeframe: Baseline to Month 12, Baseline to Month 24Population: Intent-to-treat and last observation carried forward
Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion
Outcome measures
| Measure |
1/4 Fluence Triple Therapy
n=39 Participants
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 Participants
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 Participants
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Mean Change From Baseline in Lesion Size
Baseline to Month 12
|
77.2 micron
Standard Deviation 960.3
|
-20.4 micron
Standard Deviation 1550.7
|
152.0 micron
Standard Deviation 1415.5
|
-192.6 micron
Standard Deviation 672.5
|
|
Mean Change From Baseline in Lesion Size
Baseline to Month 24
|
94.8 micron
Standard Deviation 865.1
|
-103.3 micron
Standard Deviation 1326.1
|
-112.5 micron
Standard Deviation 1209.4
|
-205.3 micron
Standard Deviation 653.4
|
Adverse Events
1/4 Fluence Triple Therapy
Serious events: 10 serious events
Other events: 36 other events
Deaths: 0 deaths
1/2 Fluence Triple Therapy
Serious events: 13 serious events
Other events: 36 other events
Deaths: 0 deaths
1/2 Fluence Double Therapy
Serious events: 15 serious events
Other events: 36 other events
Deaths: 0 deaths
Ranibizumab
Serious events: 19 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1/4 Fluence Triple Therapy
n=39 participants at risk
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 participants at risk
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 participants at risk
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 participants at risk
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
Cardiac disorders
AV block complete
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
AV block second degree
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
General disorders
Abdominal Pain
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
General disorders
Accidental Injury
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Renal and urinary disorders
Acute kidney failure
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
General disorders
Anaphylactoid Reaction
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Blood and lymphatic system disorders
Aplastic anemia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Arteriosclerosis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Reproductive system and breast disorders
Breast carcinoma
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Bundle Branch Block
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
General disorders
Cellulitis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Cerebral infarct
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Cerebrovascular accident
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
General disorders
Chest pain
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Cholecystitis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Cholelithiasis
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
General disorders
Death
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Endocarditis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Gastrointestinal carcinoma
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Gastrointestinal neoplasia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Healing abnormal
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Heart arrest
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
General disorders
Hernia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Hypertension
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Hypotension
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Hypoxia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Eye disorders
Increased intraocular pressure (study eye)
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
General disorders
Infection
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
General disorders
Infection bacterial
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Intestinal perforation
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Renal and urinary disorders
Kidney failure
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Lung edema
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
General disorders
Neck pain
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
General disorders
Pain
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Pancreatitis
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Postural Hypotension
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Psychosis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Pyogenic arthritis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Eye disorders
Retinal detachment (study eye)
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Eye disorders
Retinal tear (study eye)
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
General disorders
Sepsis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Syncope
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Thinking abnormal
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Vascular anomaly
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Vertigo
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
General disorders
Viral infection
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Eye disorders
Vision decreased (study eye)
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Eye disorders
Visual field defect (study eye)
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Eye disorders
Vitreous hemorrhage (study eye)
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Coronary artery disorder
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Peripheral vascular disorder
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Pulmonary embolus
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Cholangitis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Liver damage
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Endocrine disorders
Adrenal disorder
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Blood and lymphatic system disorders
Anemia
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Blood and lymphatic system disorders
Blood dyscrasia
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Bone neoplasm
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Confusion
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Convulsion
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
Other adverse events
| Measure |
1/4 Fluence Triple Therapy
n=39 participants at risk
Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Triple Therapy
n=39 participants at risk
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy \[within 2 hours\] on Day 0 and then as required every 2 months thereafter
|
1/2 Fluence Double Therapy
n=43 participants at risk
Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy \[within 2 hours\]
|
Ranibizumab
n=41 participants at risk
Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
|
|---|---|---|---|---|
|
General disorders
Accidental Injury
|
15.4%
6/39 • Number of events 11 • Month 0 to Month 24/last visit
|
12.8%
5/39 • Number of events 9 • Month 0 to Month 24/last visit
|
16.3%
7/43 • Number of events 11 • Month 0 to Month 24/last visit
|
22.0%
9/41 • Number of events 15 • Month 0 to Month 24/last visit
|
|
Eye disorders
Age-related Macular Degeneration progression (fellow eye)
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
20.5%
8/39 • Number of events 8 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Anxiety
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
General disorders
Asthenia
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 5 • Month 0 to Month 24/last visit
|
11.6%
5/43 • Number of events 7 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
General disorders
Back pain
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Eye disorders
Blepharitis (fellow eye)
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Eye disorders
Blepharitis (study eye)
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
Eye disorders
Cataract (fellow eye)
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
9.8%
4/41 • Number of events 4 • Month 0 to Month 24/last visit
|
|
Eye disorders
Cataract (study eye)
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
14.0%
6/43 • Number of events 6 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
General disorders
Chest pain
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
100.0%
1/1 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
Eye disorders
Conjunctivitis (study eye)
|
5.1%
2/39 • Number of events 4 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Eye disorders
Corneal lesion (study eye)
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough increased
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
14.0%
6/43 • Number of events 6 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Dehydration
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Dizziness
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
12.8%
5/39 • Number of events 5 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Blood and lymphatic system disorders
Ecchymosis
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 3 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 5 • Month 0 to Month 24/last visit
|
|
Eye disorders
Eye itching (fellow eye)
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
Eye disorders
Eye itching (study eye)
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 4 • Month 0 to Month 24/last visit
|
|
Eye disorders
Eye pain (study eye)
|
17.9%
7/39 • Number of events 15 • Month 0 to Month 24/last visit
|
23.1%
9/39 • Number of events 11 • Month 0 to Month 24/last visit
|
20.9%
9/43 • Number of events 15 • Month 0 to Month 24/last visit
|
24.4%
10/41 • Number of events 23 • Month 0 to Month 24/last visit
|
|
General disorders
Flu syndrome
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
9.8%
4/41 • Number of events 4 • Month 0 to Month 24/last visit
|
|
General disorders
Headache
|
7.7%
3/39 • Number of events 4 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 2 • Month 0 to Month 24/last visit
|
9.3%
4/43 • Number of events 4 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
7.0%
3/43 • Number of events 3 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Hyperlipemia
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Hypertension
|
17.9%
7/39 • Number of events 9 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
16.3%
7/43 • Number of events 7 • Month 0 to Month 24/last visit
|
12.2%
5/41 • Number of events 5 • Month 0 to Month 24/last visit
|
|
Eye disorders
Increased intraocular pressure (study eye)
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 12 • Month 0 to Month 24/last visit
|
14.0%
6/43 • Number of events 8 • Month 0 to Month 24/last visit
|
14.6%
6/41 • Number of events 8 • Month 0 to Month 24/last visit
|
|
General disorders
Infection
|
17.9%
7/39 • Number of events 9 • Month 0 to Month 24/last visit
|
17.9%
7/39 • Number of events 9 • Month 0 to Month 24/last visit
|
11.6%
5/43 • Number of events 8 • Month 0 to Month 24/last visit
|
19.5%
8/41 • Number of events 10 • Month 0 to Month 24/last visit
|
|
General disorders
Infusion-related back pain
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 5 • Month 0 to Month 24/last visit
|
9.3%
4/43 • Number of events 8 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
General disorders
Injection site pain
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
7.0%
3/43 • Number of events 4 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
9.3%
4/43 • Number of events 4 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
General disorders
Pain
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
9.3%
4/43 • Number of events 4 • Month 0 to Month 24/last visit
|
12.2%
5/41 • Number of events 5 • Month 0 to Month 24/last visit
|
|
Metabolism and nutrition disorders
Peripheral edema
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Peripheral vascular disorder
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
7.0%
3/43 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.6%
1/39 • Number of events 2 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Syncope
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
12.8%
5/39 • Number of events 5 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Renal and urinary disorders
Urinary tract infection
|
5.1%
2/39 • Number of events 8 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
9.3%
4/43 • Number of events 4 • Month 0 to Month 24/last visit
|
14.6%
6/41 • Number of events 8 • Month 0 to Month 24/last visit
|
|
Eye disorders
Vision abnormal (study eye)
|
20.5%
8/39 • Number of events 10 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
16.3%
7/43 • Number of events 10 • Month 0 to Month 24/last visit
|
9.8%
4/41 • Number of events 4 • Month 0 to Month 24/last visit
|
|
Eye disorders
Vision decreased (study eye)
|
12.8%
5/39 • Number of events 6 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
14.0%
6/43 • Number of events 8 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Eye disorders
Visual field defect (study eye)
|
12.8%
5/39 • Number of events 5 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
9.8%
4/41 • Number of events 4 • Month 0 to Month 24/last visit
|
|
Eye disorders
Vitreous disorder (study eye)
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
7.0%
3/43 • Number of events 3 • Month 0 to Month 24/last visit
|
12.2%
5/41 • Number of events 5 • Month 0 to Month 24/last visit
|
|
General disorders
Abdominal pain
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
General disorders
Allergic reaction
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
General disorders
Injection site extravasation
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
7.0%
3/43 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Bradycardia
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Cardiovascular disorder
|
5.1%
2/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 5 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Cerebral ischemia
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Hemorrhage
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Cardiac disorders
Vascular anomaly
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Constipation
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
2/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 2 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
9.3%
4/43 • Number of events 4 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Periodontal abscess
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
Gastrointestinal disorders
Hypothyroidism
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 4 • Month 0 to Month 24/last visit
|
7.0%
3/43 • Number of events 3 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Acute brain syndrome
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Dementia
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Depression
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Nervous system disorders
Neuralgia
|
5.1%
2/39 • Number of events 3 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
9.3%
4/43 • Number of events 4 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Skin and subcutaneous tissue disorders
Skin carcinoma
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 2 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 4 • Month 0 to Month 24/last visit
|
|
Eye disorders
Conjunctivitis (fellow eye)
|
5.1%
2/39 • Number of events 3 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Eye disorders
Dry eyes (fellow eye)
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Eye disorders
Retinal disorder (fellow eye)
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Eye disorders
Vitreous detachment (fellow eye)
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
7.3%
3/41 • Number of events 3 • Month 0 to Month 24/last visit
|
|
Eye disorders
Diplopia (study eye)
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Eye disorders
Dry eyes (study eye)
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
2.6%
1/39 • Number of events 2 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Eye disorders
Retinal disorder (study eye)
|
7.7%
3/39 • Number of events 3 • Month 0 to Month 24/last visit
|
10.3%
4/39 • Number of events 5 • Month 0 to Month 24/last visit
|
2.3%
1/43 • Number of events 1 • Month 0 to Month 24/last visit
|
2.4%
1/41 • Number of events 1 • Month 0 to Month 24/last visit
|
|
Eye disorders
Subconjunctival hemorrhage (study eye)
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 4 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 3 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
0.00%
0/41 • Month 0 to Month 24/last visit
|
|
Renal and urinary disorders
Kidney function abnormal
|
0.00%
0/39 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
0.00%
0/43 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
|
Renal and urinary disorders
Prostatic disorder
|
2.6%
1/39 • Number of events 1 • Month 0 to Month 24/last visit
|
5.1%
2/39 • Number of events 2 • Month 0 to Month 24/last visit
|
4.7%
2/43 • Number of events 3 • Month 0 to Month 24/last visit
|
4.9%
2/41 • Number of events 2 • Month 0 to Month 24/last visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication materials will be reviewed and commented on by the Sponsor prior to submission for publication; Names of all Investigators and Sponsor representatives responsible for study design and analysis of results will be disclosed in the publication.
- Publication restrictions are in place
Restriction type: OTHER