Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy
Conditions
Keywords
Polypoidal choroidal vasculopathy, Visual acuity, Ranibizumab, Verteporfin PDT
Brief summary
This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.
Detailed description
Patients were randomized to the study in 2 treatment groups: ranibizumab + vPDT combination therapy, and ranibizumab monotherapy. Based on the results of the primary analysis at Month 12, patients still in the ranibizumab monotherapy group at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit. A total of 168 and 154 patients were included in the ranibizumab + vPDT combined therapy and ranibizumab monotherapy groups, respectively for the FAS (Month 12 analysis). However, the safety set included 172 and 149 patients, respectively. Four patients in the combination therapy group never took vPDT . Among them, 1 patient actually received verteporfin injection but no laser injection. Thus a total of 3 patients (4-1) in the combination therapy group did not take the actual full vPDT treatment. Additionally, 7 patients in the monotherapy group received vPDT and 1 patient from the monotherapy group did not receive ranibizumab treatment. Considering the above numbers, safety set included 172 patients (i.e., 168-3+7) in the ranibizumab + vPDT combination therapy group and 149 patients (i.e., 154-7+3-1) in the ranibizumab monotherapy group for Month 12 analysis. For the Month 24 safety analysis, the 14 patients in the ranibizumab monotherapy group who were switched to ranibizumab +vPDT combination therapy group were analyzed as a separate group, ie, ranibizumab 0.5 mg + vPDT (switched). .
Interventions
DRUGRanibizumab
Intravitreal injection of 0.5 mg ranibizumab
DRUGVerteporfin PDT
Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
DRUGSham PDT
Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of symptomatic macular PCV in the study eye * A qualifying vision score at study entry * A qualifying lesion size in the study eye at study entry
Exclusion criteria
* Active inflammation or infection in the study eye * Uncontrolled intraocular pressure in the stuy eye * Ocular condition in the study eye which may impact vision and confound study outcomes * Prior treatment of the study eye with anti-VEGF therapy, verteporfin PDT, other laser and surgical interventions, intraocular corticosteroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye | Baseline, Month 12 | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity. |
| Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye | Baseline, Month 12 | Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value No. Polyp regression which may lead to disease stabilization and consequently better vision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of BCVA (Within 5 Letter Change) at Month 12 and 24 Compared to BCVA at the Time Point of First Ranibizumab Treatment Interruption | Month 3, Month 12, Month 24 | Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. |
| Change in BCVA at Month 12 and 24 Compared to the Time Point of First Ranibizumab Treatment Interruption | Month 3, Month 12, Month 24 | Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. |
| Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6, Month 24 | Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value No. Polyp regression which may lead to disease stabilization and consequently better vision. |
| Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6, Month 12 and Month 24 | Presence of lesion leakage was based on Fluorescein Angiography (FA) as assessed by the Central Reading Center (CRC). The presence of leakage may lead to disease progression and worsening vision. |
| Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Baseline, Month 24 | The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. |
| Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12 | Baseline, Month 12 | — |
| Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12 | Baseline, Month 12 | — |
| Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye | Baseline, Month 24 | Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity. |
| Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24 | Baseline, Month 24 | — |
| Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12 | Month 3, Month 12 | — |
| Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24 | Month 3, Month 24 | — |
| Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Baseline, Month 3, Month 12, Month 24 | The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Months 3, 12 and 24. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function. |
| Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Up to Month 24 | Reported categorically: Mild, Moderate, Severe |
| Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Up to Month 24 | Reported categorically: Mild, Moderate, Severe |
| Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24 | Baseline, Month 24 | — |
| Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | Baseline, Month 24 | 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. |
Countries
Hong Kong, Japan, Malaysia, Singapore, South Korea, Taiwan, Thailand
Participant flow
Recruitment details
This study was conducted in the following jurisdictions: Japan (25 centers), Malaysia (2 centers), Singapore (4 centers), Hong Kong (2 centers), Taiwan (6 centers), Thailand (3 centers) and Korea (5 centers).
Pre-assignment details
The enrollment number in the protocol section reflects the number of participants treated (321). The total number in the participant flow and baseline characteristics sections reflects the number of participants randomized (322).
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab 0.5 mg + vPDT Treatment initiation with Ranibizumab and verteporfin PDT (vPDT), with re-treatment need (either Ranibizumab alone or combined with vPDT) | 168 |
| Ranibizumab 0.5 mg Treatment initiation with Ranibizumab and Sham PDT, with re-treatment need (either Ranibizumab alone or combined with Sham PDT) | 113 |
| Ranibizumab 0.5 mg + vPDT (Switched) Based on the results of the primary analysis at Month 12, patients still in the Ranibizumab monotherapy group (Ranibizumab 0.5 mg) at the time of the switch cut-off time point were switched to the ranibizumab + vPDT combination therapy group until study exit | 41 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problems | 1 | 0 | 0 |
| Overall Study | Adverse Event | 9 | 7 | 0 |
| Overall Study | Death | 2 | 1 | 0 |
| Overall Study | Disease Progression | 0 | 4 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 2 | 0 |
| Overall Study | Protocol Deviation | 2 | 3 | 0 |
| Overall Study | Subject withdrew consent | 5 | 8 | 0 |
Baseline characteristics
| Characteristic | Ranibizumab 0.5 mg + vPDT | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg + vPDT (Switched) | Total |
|---|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 8.54 | 67.8 years STANDARD_DEVIATION 9.19 | 69.2 years STANDARD_DEVIATION 8.57 | 68.1 years STANDARD_DEVIATION 8.76 |
| Sex: Female, Male Female | 59 Participants | 30 Participants | 8 Participants | 97 Participants |
| Sex: Female, Male Male | 109 Participants | 83 Participants | 33 Participants | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 172 | 1 / 135 | 0 / 14 |
| other Total, other adverse events | 80 / 172 | 45 / 135 | 11 / 14 |
| serious Total, serious adverse events | 27 / 172 | 23 / 135 | 2 / 14 |
Outcome results
Primary
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.
Time frame: Baseline, Month 12
Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye | 8.3 Letters | Standard Error 1 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye | 5.1 Letters | Standard Error 1.06 |
p-value: <0.001ANCOVA
Primary
Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye
Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value No. Polyp regression which may lead to disease stabilization and consequently better vision.
Time frame: Baseline, Month 12
Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye | 115 Participants |
| Ranibizumab 0.5 mg | Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye | 52 Participants |
p-value: <0.0001Fisher Exact
Secondary
Change in BCVA at Month 12 and 24 Compared to the Time Point of First Ranibizumab Treatment Interruption
Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters.
Time frame: Month 3, Month 12, Month 24
Population: Prior to DB lock, the statistical analysis plan was amended and this endpoint was removed (initially included in order to assess VA maintenance during the PRN phase after the loading phase of ranibizumab 0.5 mg). When SAP was finalized, this question had already been addressed (CRF002A2413 (NCT01775124), FVF4579g (NCT00891735)): no data collected.
Secondary
Maintenance of BCVA (Within 5 Letter Change) at Month 12 and 24 Compared to BCVA at the Time Point of First Ranibizumab Treatment Interruption
Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters.
Time frame: Month 3, Month 12, Month 24
Population: Prior to DB lock, the statistical analysis plan was amended and this endpoint was removed (initially included in order to assess VA maintenance during the PRN phase after the loading phase of ranibizumab 0.5 mg). When SAP was finalized, this question had already been addressed (CRF002A2413 (NCT01775124), FVF4579g (NCT00891735)): no data collected.
Secondary
Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye
Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.
Time frame: Baseline, Month 24
Population: All patients with a BCVA value for both baseline and Month 24
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye | 9.7 Letters | Standard Error 11.74 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye | 5.4 Letters | Standard Error 12.75 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye | 6.1 Letters | Standard Error 13.84 |
Secondary
Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Months 3, 12 and 24. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.
Time frame: Baseline, Month 3, Month 12, Month 24
Population: All patients with a value for both baseline and the specific post-baseline visit. The baseline value is the last available, non-missing, value collected prior to first study treatment in the study eye.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 12 - Value at Baseline | 76.4 Unit of scales | Standard Deviation 13.6 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 24 - Change from Baseline | 5.5 Unit of scales | Standard Deviation 13.23 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 12 - Change from Baseline | 6.4 Unit of scales | Standard Deviation 12.31 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 12 - Value at Visit | 82.8 Unit of scales | Standard Deviation 13.55 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 3 - Value at Baseline | 76.5 Unit of scales | Standard Deviation 13.78 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 24 - Value at Visit | 81.9 Unit of scales | Standard Deviation 14.12 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 3 - Change from Baseline | 2.9 Unit of scales | Standard Deviation 9.34 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 3 - Value at Visit | 79.4 Unit of scales | Standard Deviation 13.38 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 24 - Value at Baseline | 76.4 Unit of scales | Standard Deviation 13.72 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 12 - Value at Visit | 81.2 Unit of scales | Standard Deviation 13.54 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 3 - Value at Baseline | 75.9 Unit of scales | Standard Deviation 14.7 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 3 - Value at Visit | 80.5 Unit of scales | Standard Deviation 12.21 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 3 - Change from Baseline | 4.6 Unit of scales | Standard Deviation 10.52 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 12 - Value at Baseline | 75.8 Unit of scales | Standard Deviation 15.2 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 12 - Change from Baseline | 5.4 Unit of scales | Standard Deviation 13.54 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 24 - Value at Baseline | 76 Unit of scales | Standard Deviation 15.48 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 24 - Value at Visit | 80.8 Unit of scales | Standard Deviation 13.37 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 24 - Change from Baseline | 4.8 Unit of scales | Standard Deviation 14.92 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 3 - Change from Baseline | 1.7 Unit of scales | Standard Deviation 8.85 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 3 - Value at Baseline | 80.9 Unit of scales | Standard Deviation 12.47 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 24 - Value at Baseline | 80.3 Unit of scales | Standard Deviation 12.77 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 3 - Value at Visit | 82.5 Unit of scales | Standard Deviation 11.53 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 24 - Change from Baseline | 2.8 Unit of scales | Standard Deviation 15.69 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 12 - Value at Visit | 83 Unit of scales | Standard Deviation 11.18 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 12 - Value at Baseline | 80.3 Unit of scales | Standard Deviation 12.77 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 24 - Value at Visit | 83.2 Unit of scales | Standard Deviation 12.12 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24 | Month 12 - Change from Baseline | 2.7 Unit of scales | Standard Deviation 13.76 |
Secondary
Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye
The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease.
Time frame: Baseline, Month 24
Population: All patients with a value at baseline and at Month 24
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Value at Month 24 | 248.8 Micrometers | Standard Error 64.7 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Value at Baseline | 401.6 Micrometers | Standard Error 142.74 |
| Ranibizumab 0.5 mg + vPDT | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Change from Baseline | -152.9 Micrometers | Standard Error 129.74 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Value at Month 24 | 294.5 Micrometers | Standard Error 108.61 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Value at Baseline | 390 Micrometers | Standard Error 124.12 |
| Ranibizumab 0.5 mg | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Change from Baseline | -95.5 Micrometers | Standard Error 148.36 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Value at Baseline | 412.5 Micrometers | Standard Error 143.16 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Change from Baseline | -138.7 Micrometers | Standard Error 124.94 |
| Ranibizumab 0.5 mg + vPDT (Switched) | Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye | Value at Month 24 | 273.8 Micrometers | Standard Error 73.31 |
Secondary
Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class
Reported categorically: Mild, Moderate, Severe
Time frame: Up to Month 24
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Moderate | 17 Adverse Events |
| Ranibizumab 0.5 mg + vPDT | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Mild | 65 Adverse Events |
| Ranibizumab 0.5 mg + vPDT | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Severe | 12 Adverse Events |
| Ranibizumab 0.5 mg | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Moderate | 17 Adverse Events |
| Ranibizumab 0.5 mg | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Mild | 49 Adverse Events |
| Ranibizumab 0.5 mg | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Severe | 6 Adverse Events |
| Ranibizumab 0.5 mg + vPDT (Switched) | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Mild | 6 Adverse Events |
| Ranibizumab 0.5 mg + vPDT (Switched) | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Severe | 1 Adverse Events |
| Ranibizumab 0.5 mg + vPDT (Switched) | Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Moderate | 2 Adverse Events |
Secondary
Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class
Reported categorically: Mild, Moderate, Severe
Time frame: Up to Month 24
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Moderate | 7 Adverse Events |
| Ranibizumab 0.5 mg + vPDT | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Mild | 55 Adverse Events |
| Ranibizumab 0.5 mg + vPDT | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Severe | 2 Adverse Events |
| Ranibizumab 0.5 mg | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Moderate | 11 Adverse Events |
| Ranibizumab 0.5 mg | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Mild | 31 Adverse Events |
| Ranibizumab 0.5 mg | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Severe | 7 Adverse Events |
| Ranibizumab 0.5 mg + vPDT (Switched) | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Mild | 7 Adverse Events |
| Ranibizumab 0.5 mg + vPDT (Switched) | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Severe | 0 Adverse Events |
| Ranibizumab 0.5 mg + vPDT (Switched) | Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class | Moderate | 1 Adverse Events |
Secondary
Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - 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.
Time frame: Baseline, Month 24
Population: All participants with a BCVA value for both Baseline and Month 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | ≥ 15 letters gain | 30.8 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 30 letters loss | 99.3 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 10 letters loss | 94.5 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 5 letters loss | 89.7 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | ≥ 10 letters gain | 51.4 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | ≥ 5 letters gain | 74.0 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 15 letters loss | 95.2 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 5 letters loss | 85.1 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | ≥ 5 letters gain | 57.5 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | ≥ 10 letters gain | 36.8 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | ≥ 15 letters gain | 24.1 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 10 letters loss | 92.0 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 15 letters loss | 95.4 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 30 letters loss | 97.7 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 10 letters loss | 90.2 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | ≥ 10 letters gain | 43.9 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 30 letters loss | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 15 letters loss | 92.7 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | < 5 letters loss | 82.9 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | ≥ 15 letters gain | 24.4 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye | ≥ 5 letters gain | 51.2 Percentage of participants |
Secondary
Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye
Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value No. Polyp regression which may lead to disease stabilization and consequently better vision.
Time frame: Month 6, Month 24
Population: All patients who attended the specific visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6 - Yes | 71.3 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6 - No | 28.7 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 24 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 24 - Yes | 56.6 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 24 - No | 43.4 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 24 - No | 73.3 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 24 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 24 - Yes | 26.7 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6 - Yes | 30.4 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6 - No | 69.6 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6 - Yes | 22.0 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6 - No | 78.0 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 24 - No | 52.5 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 24 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 6 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye | Month 24 - Yes | 47.5 Percentage of participants |
Secondary
Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye
Presence of lesion leakage was based on Fluorescein Angiography (FA) as assessed by the Central Reading Center (CRC). The presence of leakage may lead to disease progression and worsening vision.
Time frame: Month 6, Month 12 and Month 24
Population: All patients who attended the specific visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - Yes | 43 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - No | 55.1 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - Can't grade | 0.6 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - Missing | 1.3 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - Yes | 47.7 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - No | 51.6 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - Missing | 0 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Yes | 56.8 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - No | 40.4 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Can't grade | 0.7 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Missing | 2.1 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - No | 34.9 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - No | 26.5 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - No | 27.4 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - Yes | 72.6 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Yes | 65.1 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - Yes | 73.5 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Missing | 2.4 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Yes | 56.1 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - Yes | 80.5 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Can't grade | 2.4 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 12 - No | 19.5 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - Total | 100 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - No | 39 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - Yes | 78 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 6 - No | 22 Percentage of participants |
| Ranibizumab 0.5 mg + vPDT (Switched) | Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye | Month 24 - Total | 100 Percentage of participants |
Secondary
Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12
Time frame: Month 3, Month 12
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12 | 378 injections |
| Ranibizumab 0.5 mg | Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12 | 651 injections |
Secondary
Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24
Time frame: Month 3, Month 24
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24 | 913 injections |
| Ranibizumab 0.5 mg | Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24 | 1229 injections |
| Ranibizumab 0.5 mg + vPDT (Switched) | Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24 | 183 injections |
Secondary
Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12
Time frame: Baseline, Month 12
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12 | 887 injections |
| Ranibizumab 0.5 mg | Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12 | 1089 injections |
Secondary
Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24
Time frame: Baseline, Month 24
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24 | 1422 injections |
| Ranibizumab 0.5 mg | Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24 | 1625 injections |
| Ranibizumab 0.5 mg + vPDT (Switched) | Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24 | 225 injections |
Secondary
Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12
Time frame: Baseline, Month 12
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12 | 264 injections |
| Ranibizumab 0.5 mg | Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12 | 345 injections |
Secondary
Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24
Time frame: Baseline, Month 24
Population: Safety Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab 0.5 mg + vPDT | Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24 | 389 injections |
| Ranibizumab 0.5 mg | Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24 | 459 injections |
| Ranibizumab 0.5 mg + vPDT (Switched) | Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24 | 81 injections |