Trial Outcomes & Findings for Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD) (NCT NCT00433017)
NCT ID: NCT00433017
Last Updated: 2011-04-21
Results Overview
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
255 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2011-04-21
Participant Flow
Participant milestones
| Measure |
Verteporfin + Ranibizumab
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
133
|
|
Overall Study
Completed 12 Month Phase
|
114
|
126
|
|
Overall Study
COMPLETED
|
26
|
32
|
|
Overall Study
NOT COMPLETED
|
96
|
101
|
Reasons for withdrawal
| Measure |
Verteporfin + Ranibizumab
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Administrative problems
|
80
|
86
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Subject no longer requires study drug
|
1
|
1
|
Baseline Characteristics
Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
Verteporfin + Ranibizumab
n=122 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
n=133 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
76.8 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
75.5 years
STANDARD_DEVIATION 7.44 • n=7 Participants
|
76.1 years
STANDARD_DEVIATION 7.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Performed on the Full analysis set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. FAS consisted of all patients as randomized that received at least one application of study drug and had at least one post-baseline assessment for best corrected visual acuity in the study eye.
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.
Outcome measures
| Measure |
Verteporfin + Ranibizumab
n=121 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
n=132 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
|---|---|---|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.
Baseline
|
54.6 Letters
Standard Deviation 13.5
|
55.1 Letters
Standard Deviation 12.3
|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.
Month 12
|
57.1 Letters
Standard Deviation 18.3
|
59.4 Letters
Standard Deviation 18.8
|
|
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.
Change from Baseline
|
2.5 Letters
Standard Deviation 14.82
|
4.4 Letters
Standard Deviation 15.92
|
PRIMARY outcome
Timeframe: Month 2 to Month 11Population: Full analysis set. Includes number of participants in the treatment group with at least one visit assessment of re-treatment.
The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.
Outcome measures
| Measure |
Verteporfin + Ranibizumab
n=119 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
n=128 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
|---|---|---|
|
Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit
|
95.8 Percentage of Participants
|
92.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Month 12Population: The Full Analysis Set (FAS) based on observed data.
The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
Outcome measures
| Measure |
Verteporfin + Ranibizumab
n=97 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
n=115 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
|---|---|---|
|
Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12
|
28.9 Percentage of participants
|
25.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full analysis set based on observed data.
Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage.
Outcome measures
| Measure |
Verteporfin + Ranibizumab
n=92 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
n=107 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
|---|---|---|
|
Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12
Baseline
|
7.4 mm^2
Standard Deviation 4.63
|
8.1 mm^2
Standard Deviation 5.82
|
|
Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12
Month 12
|
2.2 mm^2
Standard Deviation 4.88
|
2.0 mm^2
Standard Deviation 4.68
|
|
Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12
Change from Baseline
|
-5.3 mm^2
Standard Deviation 5.32
|
-6.1 mm^2
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Full analysis set, LOCF
Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness.
Outcome measures
| Measure |
Verteporfin + Ranibizumab
n=119 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
n=128 Participants
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
|---|---|---|
|
Mean Change in Central Retinal Thickness of the Study Eye at Month 12
Baseline
|
335.2 μm
Standard Deviation 94.7
|
339.8 μm
Standard Deviation 125.6
|
|
Mean Change in Central Retinal Thickness of the Study Eye at Month 12
Month 12
|
219.9 μm
Standard Deviation 61.1
|
232.0 μm
Standard Deviation 54.5
|
|
Mean Change in Central Retinal Thickness of the Study Eye at Month 12
Change from Baseline
|
-115.3 μm
Standard Deviation 98.7
|
-107.7 μm
Standard Deviation 124.6
|
Adverse Events
Verteporfin + Ranibizumab
Serious events: 25 serious events
Other events: 64 other events
Deaths: 0 deaths
Ranibizumab
Serious events: 28 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Verteporfin + Ranibizumab
n=122 participants at risk
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
n=133 participants at risk
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
|---|---|---|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.6%
2/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Cardiac disorders
CARDIAC VALVE DISEASE
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
1.6%
2/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
CATARACT (Fellow eye)
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
CATARACT (Study eye)
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
1.5%
2/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
CHORIORETINAL ATROPHY (Study eye)
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
GLAUCOMA (Fellow eye)
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
GLAUCOMA (Study eye)
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
LAGOPHTHALMOS (Fellow eye)
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
PARALYTIC LAGOPHTHALMOS (Study eye)
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
RETINAL ARTERY OCCLUSION (Study eye)
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
RETINAL CYST (Study eye)
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
RETINAL DEGENERATION (Study eye)
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
RETINAL OEDEMA (Study eye)
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
ULCERATIVE KERATITIS (Fellow eye)
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
VISUAL ACUITY REDUCED (Study eye)
|
1.6%
2/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Gastrointestinal disorders
SALIVARY GLAND CALCULUS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Gastrointestinal disorders
VISCEROPTOSIS
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Infections and infestations
ERYSIPELAS
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Infections and infestations
LABYRINTHITIS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Infections and infestations
MASTOIDITIS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Infections and infestations
PNEUMONIA
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Infections and infestations
SIALOADENITIS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Infections and infestations
WOUND INFECTION
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
CARTILAGE INJURY
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
FALL
|
3.3%
4/122 • Includes cumulative data through 24 months.
|
1.5%
2/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Investigations
CARBOHYDRATE ANTIGEN 125 INCREASED
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GENITAL NEOPLASM MALIGNANT FEMALE
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MEDIASTINUM NEOPLASM
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO PERITONEUM
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL NEOPLASM
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
1.5%
2/133 • Includes cumulative data through 24 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
3.0%
4/133 • Includes cumulative data through 24 months.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
1.5%
2/133 • Includes cumulative data through 24 months.
|
|
Nervous system disorders
FACIAL PARESIS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Vascular disorders
ARTERIAL STENOSIS LIMB
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Vascular disorders
ILIAC ARTERY OCCLUSION
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
1.6%
2/122 • Includes cumulative data through 24 months.
|
0.00%
0/133 • Includes cumulative data through 24 months.
|
|
Vascular disorders
THROMBOSIS
|
0.82%
1/122 • Includes cumulative data through 24 months.
|
0.75%
1/133 • Includes cumulative data through 24 months.
|
Other adverse events
| Measure |
Verteporfin + Ranibizumab
n=122 participants at risk
Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
Ranibizumab
n=133 participants at risk
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
|
|---|---|---|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE (Study eye)
|
3.3%
4/122 • Includes cumulative data through 24 months.
|
7.5%
10/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
EYE PAIN (Study eye)
|
8.2%
10/122 • Includes cumulative data through 24 months.
|
6.0%
8/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
MACULAR DEGENERATION (Fellow eye)
|
3.3%
4/122 • Includes cumulative data through 24 months.
|
6.0%
8/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
OCULAR HYPERAEMIA (Study eye)
|
5.7%
7/122 • Includes cumulative data through 24 months.
|
7.5%
10/133 • Includes cumulative data through 24 months.
|
|
Eye disorders
RETINAL HAEMORRHAGE (Study eye)
|
5.7%
7/122 • Includes cumulative data through 24 months.
|
3.8%
5/133 • Includes cumulative data through 24 months.
|
|
Infections and infestations
BRONCHITIS
|
4.1%
5/122 • Includes cumulative data through 24 months.
|
5.3%
7/133 • Includes cumulative data through 24 months.
|
|
Infections and infestations
INFLUENZA
|
2.5%
3/122 • Includes cumulative data through 24 months.
|
6.8%
9/133 • Includes cumulative data through 24 months.
|
|
Infections and infestations
NASOPHARYNGITIS
|
14.8%
18/122 • Includes cumulative data through 24 months.
|
11.3%
15/133 • Includes cumulative data through 24 months.
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED (Study eye)
|
9.0%
11/122 • Includes cumulative data through 24 months.
|
6.0%
8/133 • Includes cumulative data through 24 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.6%
8/122 • Includes cumulative data through 24 months.
|
2.3%
3/133 • Includes cumulative data through 24 months.
|
|
Vascular disorders
HYPERTENSION
|
15.6%
19/122 • Includes cumulative data through 24 months.
|
9.8%
13/133 • Includes cumulative data through 24 months.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER