Pathological Myopia
Conditions
Keywords
Pathologic myopia, PM, choroidal neovascularization, CNV, ranibizumab, verteporfin PDT
Brief summary
This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).
Interventions
DRUGRanibizumab
0.5 mg ranibizumab intravitreal injection
DRUGVerteporfin PDT
Verteporfin (6 mg/m2) intravenous infusion
DRUGSham Ranibizumab
Empty vial to mimic the intravitreal injection
DRUGSham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Visual impairment due to choroidal neovascularization (CNV) secondary to PM * Best corrected visual acuity (BCVA) in the study eye \> 24 and \< 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters * High myopia (\> -6D), anterior-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia * Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal
Exclusion criteria
* Patients with uncontrolled systemic or ocular diseases * Blood pressure \> 150/90 mmHg * History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye * Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Baseline, Month 1 through Month 3 | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | Baseline and Month 1 through Month 12 | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12 |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | Month 3 | 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 increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3. |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Months 6 and 12 | 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 increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12. |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | Month 3 | 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. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3. |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Months 6 and 12 | 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. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12. |
| Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Baseline and Month 6 | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet. |
| Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline and Month 12 | CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators. |
| Number of Ranibizumab Injections Received Prior to Month 3 | Day 1 and prior to month 3 | In order to describe exposure to the study drug the number of ejections was evaluated |
| Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period | Day 1 prior to month 6 and prior to month 12 | Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period |
| Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period | Month 3 up to month 12 | Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period. |
| Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Baseline, Month 3, Month 6 and Month 12 | Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators. |
Countries
Austria, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Latvia, Lithuania, Poland, Portugal, Singapore, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Participant flow
Recruitment details
Out of the 334 patients screened, 277 patients were randomized into the study on a 2:2:1 basis: 106 patients to Group I (treatment with ranibizumab according to visual acuity stabilization), 116 patients to Group II (ranibizumab treatment according to disease activity), and 55 patients to Group III (treatment with vPDT)
Participants by arm
| Arm | Count |
|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA). | 106 |
| 0.5mg Ranibizumab Driven by Disease Activity Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria | 116 |
| Verteporfin PDT Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed. | 55 |
| Total | 277 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | 0.5 mg Ranibizumab Driven by Stabilization Criteria | 0.5mg Ranibizumab Driven by Disease Activity | Verteporfin PDT | Total |
|---|---|---|---|---|
| Age, Customized 45 -< 55 years | 27 Participants | 21 Participants | 16 Participants | 64 Participants |
| Age, Customized <45 years | 24 Participants 22.6 | 24 Participants 20.7 | 7 Participants 12.7 | 55 Participants |
| Age, Customized 55-<65 years | 30 Participants | 34 Participants | 14 Participants | 78 Participants |
| Age, Customized >=65 | 25 Participants | 37 Participants | 18 Participants | 80 Participants |
| Sex: Female, Male Female | 82 Participants | 87 Participants | 40 Participants | 209 Participants |
| Sex: Female, Male Male | 24 Participants | 29 Participants | 15 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 46 / 106 | 47 / 118 | 17 / 38 | 8 / 15 |
| serious Total, serious adverse events | 7 / 106 | 6 / 118 | 0 / 38 | 0 / 15 |
Outcome results
Primary
Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye
The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.
Time frame: Baseline, Month 1 through Month 3
Population: Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Baseline | 55.4 Letters | Standard Deviation 13.43 |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Average Month 1 to month 3 | 66.0 Letters | Standard Deviation 12.98 |
| 0.5mg Ranibizumab Driven by Disease Activity | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Baseline | 55.8 Letters | Standard Deviation 12.59 |
| 0.5mg Ranibizumab Driven by Disease Activity | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Average Month 1 to month 3 | 66.4 Letters | Standard Deviation 12.28 |
| Verteporfin PDT | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Baseline | 54.7 Letters | Standard Deviation 13.84 |
| Verteporfin PDT | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | Average Month 1 to month 3 | 56.9 Letters | Standard Deviation 14.49 |
Secondary
Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye
The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12
Time frame: Baseline and Month 1 through Month 12
Population: Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | Baseline | 55.4 Letters | Standard Deviation 13.43 |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | Average Month 1 to Month 12 | 68.3 Letters | Standard Deviation 12.61 |
| 0.5mg Ranibizumab Driven by Disease Activity | Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | Baseline | 55.8 Letters | Standard Deviation 12.59 |
| 0.5mg Ranibizumab Driven by Disease Activity | Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | Average Month 1 to Month 12 | 68.3 Letters | Standard Deviation 12.45 |
| Verteporfin PDT | Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | Baseline | 54.7 Letters | Standard Deviation 13.84 |
| Verteporfin PDT | Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | Average Month 1 to Month 12 | 61.1 Letters | Standard Deviation 14.86 |
Secondary
Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye
The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.
Time frame: Baseline and Month 6
Population: Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Average month 1 to month 6 | 69.2 Letters | Standard Deviation 12.44 |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Baseline | 55.4 Letters | Standard Deviation 13.43 |
| 0.5mg Ranibizumab Driven by Disease Activity | Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Baseline | 55.8 Letters | Standard Deviation 12.59 |
| 0.5mg Ranibizumab Driven by Disease Activity | Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Average month 1 to month 6 | 68.4 Letters | Standard Deviation 13.56 |
| Verteporfin PDT | Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Baseline | 54.7 Letters | Standard Deviation 13.84 |
| Verteporfin PDT | Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | Average month 1 to month 6 | 62.7 Letters | Standard Deviation 14.65 |
Secondary
Change From Baseline in Central Retinal Thickness of the Study Eye Over Time
Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.
Time frame: Baseline, Month 3, Month 6 and Month 12
Population: Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Month 6 (n= 102,110,55) | 283.1 Microns | Standard Deviation 67.43 |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Month 3 (n= 102,110,54) | 288.3 Microns | Standard Deviation 70.14 |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Baseline (n=102,110, 54) | 349.2 Microns | Standard Deviation 95.05 |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Month 12 (n= 102,110,55) | 282.6 Microns | Standard Deviation 68.62 |
| 0.5mg Ranibizumab Driven by Disease Activity | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Month 3 (n= 102,110,54) | 295.6 Microns | Standard Deviation 71.93 |
| 0.5mg Ranibizumab Driven by Disease Activity | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Baseline (n=102,110, 54) | 373.1 Microns | Standard Deviation 127.44 |
| 0.5mg Ranibizumab Driven by Disease Activity | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Month 12 (n= 102,110,55) | 301.8 Microns | Standard Deviation 88.16 |
| 0.5mg Ranibizumab Driven by Disease Activity | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Month 6 (n= 102,110,55) | 298.3 Microns | Standard Deviation 81.16 |
| Verteporfin PDT | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Baseline (n=102,110, 54) | 352.5 Microns | Standard Deviation 101.52 |
| Verteporfin PDT | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Month 12 (n= 102,110,55) | 294.3 Microns | Standard Deviation 83.25 |
| Verteporfin PDT | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Month 6 (n= 102,110,55) | 303.5 Microns | Standard Deviation 76.81 |
| Verteporfin PDT | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Month 3 (n= 102,110,54) | 340.5 Microns | Standard Deviation 106.03 |
Secondary
Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period
Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period
Time frame: Day 1 prior to month 6 and prior to month 12
Population: The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab \[sham\] and/or vPDT \[sham\]) and had at least one post-baseline safety assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period | Day 1 prior to Month 6 | 3.5 injections | Standard Deviation 1.46 |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period | Day 1 prior to month 12 | 4.6 injections | Standard Deviation 2.59 |
| 0.5mg Ranibizumab Driven by Disease Activity | Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period | Day 1 prior to Month 6 | 2.5 injections | Standard Deviation 1.56 |
| 0.5mg Ranibizumab Driven by Disease Activity | Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period | Day 1 prior to month 12 | 3.5 injections | Standard Deviation 2.92 |
Secondary
Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period
Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.
Time frame: Month 3 up to month 12
Population: The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab \[sham\] and/or vPDT \[sham\]) and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period | Day 1 up to month 6 (n=34) | 1.9 injections | Standard Deviation 0.86 |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period | Day 1 up to month 12 (n=38) | 3.2 injections | Standard Deviation 2.54 |
Secondary
Number of Ranibizumab Injections Received Prior to Month 3
In order to describe exposure to the study drug the number of ejections was evaluated
Time frame: Day 1 and prior to month 3
Population: The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab \[sham\] and/or vPDT \[sham\]) and had at least one post-baseline safety assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Number of Ranibizumab Injections Received Prior to Month 3 | 2.5 injections | Standard Deviation 0.57 |
| 0.5mg Ranibizumab Driven by Disease Activity | Number of Ranibizumab Injections Received Prior to Month 3 | 1.8 injections | Standard Deviation 0.82 |
| Verteporfin PDT | Number of Ranibizumab Injections Received Prior to Month 3 | 0.0 injections | Standard Deviation 0 |
Secondary
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3
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. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.
Time frame: Month 3
Population: Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | Month 3 >=10 letters | 1.9 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | Month 3 >= 15 letters | 1.9 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | Month 3 >=10 letters | 0.9 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | Month 3 >= 15 letters | 0 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | Month 3 >=10 letters | 16.4 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | Month 3 >= 15 letters | 7.4 Percentage of Patients |
Secondary
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12
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. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.
Time frame: Months 6 and 12
Population: Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Month 6 >=10 letters | 1.9 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Month 6 >= 15 letters | 0 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Month 12 >=10 letters | 4.8 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Month 12 >= 15 letters | 1.9 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Month 12 >= 15 letters | 0.9 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Month 6 >=10 letters | 2.6 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Month 12 >=10 letters | 1.7 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | Month 6 >= 15 letters | 0.9 Percentage of Patients |
Secondary
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3
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 increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3.
Time frame: Month 3
Population: Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | Month 3 >=15 letters | 38.1 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | Month 3 >= 10 letters | 61.9 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | Month 3 >=15 letters | 43.1 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | Month 3 >= 10 letters | 65.5 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | Month 3 >=15 letters | 14.5 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | Month 3 >= 10 letters | 27.3 Percentage of Patients |
Secondary
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12
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 increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.
Time frame: Months 6 and 12
Population: Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Month 12 >=15 letters | 53.3 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Month 6 >=15 letters | 46.7 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Month 12 >= 10 letters | 69.5 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Month 6 >= 10 letters | 71.4 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Month 12 >= 10 letters | 69.0 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Month 6 >= 10 letters | 64.7 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Month 12 >=15 letters | 51.7 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | Month 6 >=15 letters | 44.8 Percentage of Patients |
Secondary
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye
CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators.
Time frame: Baseline and Month 12
Population: Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline-Definite | 96.2 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline- Questionable | 1.0 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline-Absent | 1.0 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline- Other | 1.9 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12-Definite | 21.0 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12- Questionable | 0.0 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12-Absent | 68.6 Percentage of Patients |
| 0.5 mg Ranibizumab Driven by Stabilization Criteria | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12- Other | 0.5 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline-Absent | 0.9 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12-Absent | 69.8 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline- Other | 6.1 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12-Definite | 19.0 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12- Questionable | 0.0 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline-Definite | 93.1 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline- Questionable | 0.0 Percentage of Patients |
| 0.5mg Ranibizumab Driven by Disease Activity | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12- Other | 11.2 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline-Absent | 0.0 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline- Questionable | 0.0 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline-Definite | 100.0 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Baseline- Other | 0.0 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12-Absent | 65.5 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12- Questionable | 1.8 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12-Definite | 29.1 Percentage of Patients |
| Verteporfin PDT | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | Month 12- Other | 3.6 Percentage of Patients |