Choroidal Neovascularization Secondary to Pathologic Myopia
Conditions
Keywords
pathological myopia, choroidal neovascularization, ranibizumab, mono-bilateral, poor visual acuity, retinal disease, eye disease, Angiogenesis Inhibitors, Angiogenesis Modulating Agents
Brief summary
The primary objective of the study was to investigate current criteria driving re-treatment in patients affected by Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM) and experiencing a relapse of the disease after the first administration of ranibizumab.
Interventions
DRUGRanibizumab
All patients received a single initial intravitreal injection of ranibizumab 0.5 mg/0.05 ml as per Committee for Human Medicinal Products (CHMP)approval. Further injections might have been required when monitoring reveals disease activity. Disease activity, defined as reduced visual acuity and/or signs of lesion activity, was evaluated based on clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Bilateral treatment was allowed provided at least 14 days of intercurrence.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent given before any study related procedure is performed * Diagnosis of active CNV secondary to PM confirmed by complete ocular examination in the affected eye(s) using the following criteria: * Presence of high myopia greater than -6D of spherical equivalence * Presence of posterior changes compatible with pathologic myopia (any signs of attenuation of retinal pigment epithelium (RPE) and choroids, mottling of the RPE, tilted disc, geographic atrophy of RPE, Fuchs spots, posterior staphyloma, submacular hemorrhage, lacquer cracks) detected by fundus ophthalmoscopy and fundus photography * Presence of active leakage from CNV observed through fluorescein angiography (FAG) * Presence of intra or subretinal fluid demonstrated by Optical Coherence Tomography (OCT) * BCVA \> 24 letters and \< 78 letters tested at 4 meters staring distance using ETDRS-like visual acuity chart * Visual loss must be only due to the presence of any eligible types of CNV related to PM based on clinical ocular findings, FAG and OCT. (Also patients that have for example 20/60 as their best visual acuity due to PM in their history and have additional vision loss due to CNV lesion can be included)
Exclusion criteria
* Patients with inability to comply with study related procedures * Pregnant or nursing (lactating) women and women of childbearing potential UNLESS using effective contraception during treatment * Presence of confirmed systolic blood pressure \> 150 mmHg or diastolic \> 90 mmHg at the time of enrollment * History of stroke * Any type of advanced, severe or unstable medical condition or its treatment that could significantly bias the assessment of clinical status and interfere with primary and/or secondary outcome evaluations or put the patient at risk * Presence of active infectious disease or intra-ocular inflammation in either eye at the time of enrollment * Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period (including retinal detachment, cataract and pre-retinal membrane of the macula) * History of pan-retinal or focal/grid laser photocoagulation with involvement of the macular area in the study eye at any time * History of intraocular treatment with any anti-vascular endothelial growth factor (VEGF), verteporfin photodynamic therapy (vPDT) and any intra-ocular surgery or corticosteroid administration within one month before study entrance * Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation * Simultaneous participation in a study that includes administration of any investigational drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients in Different Categories of Changes From Baseline in BCVA | Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Changes from baseline in BCVA are described for the ETDRS parameter considering the following categories at each assessment: no change if the change was equal to 0 letter, worsening if change \< 0 letter , improvement if change \> 0 letter. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change from baseline in BCVA (improved/worsened/stable) which was reported as Improved versus no change and worsened versus no change. For retreated patients, this variable was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
| Change in Central Subfield Volume (CSV) | Screening, Month 2, Month 6, Month 12 | Central subfield volume (CSV) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSV versus previous visit. For retreated patients, the change in CSV was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Screening, Month 2, Month 6, Month 12 | Presence of sub-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. The regression model for sub-retinal fluid was not valid because Yes was reported in almost all subjects causing a quasi-complete separation of data points. \*NE = Not evaluable |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Presence of clinically significant abnormalities was assessed at baseline, month 1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of clinically significant abnormalities (Yes/No). For retreated patients, the presence/absence of clinically significant abnormalities was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
| Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Improvement in BCVA \< 5 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA \< 5 letters (Yes/No) which was reported as Gain \>= 5 letters versus Gain \< 5 letters. For retreated patients, Gain \>= 5 letters and Gain \< 5 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
| Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Baseline, Month 1, Month 2, Month 3, Month 6, Month 12 | Improvement in BCVA \< 10 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA \< 10 letters (Yes/No) which was reported as Gain \>= 10 letters versus Gain \< 10 letters. For retreated patients, Gain \>= 10 letters and Gain \< 10 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening, Month 2, Month 6 | Presence of active leakage on fluorescein angiography (FAG) was assessed at screening (14 to 3 days before baseline visit), month 2 and month 6. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of active leakage (Yes/No). For retreated patients, the presence/absence of active leakage was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Screening, Month 2, Month 6, Month 12 | Presence of macular edema from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of macular edema (Yes/No). For retreated patients, the presence/absence of macular edema was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Screening, Month 2, Month 6, Month 12 | Presence of cysts from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of cysts (Yes/No). For retreated patients, the presence/absence of cysts was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable |
| Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Screening, Month 2, Month 6, Month 12 | Presence of Intra-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of Intra-retinal fluid (Yes/No). For retreated patients, the presence/absence of Intra-retinal fluid was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable |
| Change in Central Subfield Thickness (CSFT) | Screening, Month 2, Month 6, Month 12 | Central subfield thickness (CSFT) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSFT versus previous visit. For retreated patients, the change in CSFT was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Ranibizumab Injection | Baseline to Month 12 | Mean number of ranibizumab injection is reported as number of injections per patient. |
| Time to Re-treatment | Baseline to Month 12 | Time to re-treatment, defined as time in months from the data of first dose of ranibizumab to the date of re-treatment, was evaluated. |
| Number of Patients Having Ocular and/or Systemic Adverse Event (AE) | Baseline to Month 12 | Number of patients with any systemic AE, with serious systemic AE, with an ocular AE, with an ocular serious AE are reported |
| Change in Patient Quality of Life From Baseline to Month 2 and Month 12 | Baseline, Month 2, Month 12 | Patient quality of life was assessed by Impact of Vision Impairment (IVI) questionnaire. IVI is a 32-item instrument, either self- or interviewer-administered, developed to measure the impact of vision impairment on daily activities in five domains. The 32 items were divided into 5 domains as follows: Leisure and work (items 1 to 5), Social and consumer interaction (items 6 to 10 and items 23-24), Household and personal care (items 11 to 14 and items 20-21), Mobility (items 15 to 19 and item 22), Emotional reaction to vision loss (items 25 to 32). Responses to the IVI items were rated on a five-category Likert scale: not at all, 0; hardly at all, 1; a little, 2; a fair amount, 3; a lot, 4; and can't do because of eyesight, 5. Total score was an arithmetic average of the items rated between 0 (the best score) and 5 (the worst score). A negative change indicates improvement. Data was computed on items with non missing response |
| Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 6 and Month 12 on Study Eye | Baseline, Month 6, Month 12 | Change from baseline in BCVA (Best Corrected Visual Acuity) was Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score. Patients with a BCVA ETDRS letter score of 78 to 24 in the study eye were included; A higher score represents better functioning of the study eye. A positive change from baseline shows improvement. |
Countries
Italy
Participant flow
Pre-assignment details
Two hundred fifteen (215) subjects were screened in this study (i.e. provided written informed consent). Two hundred (200) subjects underwent baseline visit and received at least one injection of ranibizumab.
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab: Treated Once Patients treated only once with a single ranibizumab 0.5 mg/0.05ml intravitreal injection. | 70 |
| Ranibizumab: Re-treated Once Patients treated more than once with a single ranibizumab 0.5 mg/0.05ml intravitreal injection. | 130 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once | Total |
|---|---|---|---|
| Age, Continuous | 61.27 Years STANDARD_DEVIATION 13.03 | 62.12 Years STANDARD_DEVIATION 12.52 | 61.82 Years STANDARD_DEVIATION 12.67 |
| Sex: Female, Male Female | 53 Participants | 94 Participants | 147 Participants |
| Sex: Female, Male Male | 17 Participants | 36 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 200 |
| serious Total, serious adverse events | 7 / 200 |
Outcome results
Primary
Change in Central Subfield Thickness (CSFT)
Central subfield thickness (CSFT) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSFT versus previous visit. For retreated patients, the change in CSFT was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.
Time frame: Screening, Month 2, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point and previous visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab: Treated Once | Change in Central Subfield Thickness (CSFT) | Month 2 Vs. Screening : CSFT | -16.15 micromilimeter(um) | Standard Deviation 86.65 |
| Ranibizumab: Treated Once | Change in Central Subfield Thickness (CSFT) | Month 6 Vs. Month 2: CSFT | -11.04 micromilimeter(um) | Standard Deviation 61.06 |
| Ranibizumab: Treated Once | Change in Central Subfield Thickness (CSFT) | Month 12 Vs. Month 6: CSFT | 1.29 micromilimeter(um) | Standard Deviation 62.55 |
| Ranibizumab: Re-treated Once | Change in Central Subfield Thickness (CSFT) | Month 2 Vs. Screening : CSFT | -34.28 micromilimeter(um) | Standard Deviation 78.01 |
| Ranibizumab: Re-treated Once | Change in Central Subfield Thickness (CSFT) | Month 6 Vs. Month 2: CSFT | -15.83 micromilimeter(um) | Standard Deviation 70.74 |
| Ranibizumab: Re-treated Once | Change in Central Subfield Thickness (CSFT) | Month 12 Vs. Month 6: CSFT | 8.64 micromilimeter(um) | Standard Deviation 76.79 |
Comparison: Change in Central subfield thickness vs previous visit.p-value: 0.151495% CI: [0.99, 1]Regression, Logistic
Primary
Change in Central Subfield Volume (CSV)
Central subfield volume (CSV) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSV versus previous visit. For retreated patients, the change in CSV was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.
Time frame: Screening, Month 2, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point and the previous visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab: Treated Once | Change in Central Subfield Volume (CSV) | Month 2 Vs. Screening : CSV | -0.02 mm^3 | Standard Deviation 0.06 |
| Ranibizumab: Treated Once | Change in Central Subfield Volume (CSV) | Month 6 Vs. Month 2: CSV | -0.00 mm^3 | Standard Deviation 0.04 |
| Ranibizumab: Treated Once | Change in Central Subfield Volume (CSV) | Month 12 Vs. Month 6: CSV | -0.00 mm^3 | Standard Deviation 0.04 |
| Ranibizumab: Re-treated Once | Change in Central Subfield Volume (CSV) | Month 12 Vs. Month 6: CSV | 0.01 mm^3 | Standard Deviation 0.08 |
| Ranibizumab: Re-treated Once | Change in Central Subfield Volume (CSV) | Month 2 Vs. Screening : CSV | -0.02 mm^3 | Standard Deviation 0.06 |
| Ranibizumab: Re-treated Once | Change in Central Subfield Volume (CSV) | Month 6 Vs. Month 2: CSV | -0.01 mm^3 | Standard Deviation 0.07 |
Comparison: Change in Central subfield volume vs previous visit.p-value: 0.126595% CI: [0, 5.63]Regression, Logistic
Primary
Number of Patients in Different Categories of Changes From Baseline in BCVA
Changes from baseline in BCVA are described for the ETDRS parameter considering the following categories at each assessment: no change if the change was equal to 0 letter, worsening if change \< 0 letter , improvement if change \> 0 letter. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change from baseline in BCVA (improved/worsened/stable) which was reported as Improved versus no change and worsened versus no change. For retreated patients, this variable was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and evaluable BCVA at baseline and that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 2: Worsening | 9 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 3: Improvement | 52 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 1: Worsening | 8 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 6: No change | 5 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 2: Improvement | 50 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 6: Worsening | 9 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 2: No change | 6 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 6: Improvement | 48 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 3: No change | 3 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 12: No change | 3 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 1: Improvement | 51 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 12: Worsening | 9 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 3: Worsening | 8 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 12: Improvement | 51 Patients |
| Ranibizumab: Treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 1: No change | 7 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 12: Improvement | 92 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 1: No change | 18 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 1: Worsening | 15 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 1: Improvement | 97 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 2: No change | 9 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 2: Worsening | 25 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 2: Improvement | 95 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 3: No change | 9 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 3: Worsening | 25 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 3: Improvement | 94 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 6: No change | 6 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 6: Worsening | 30 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 6: Improvement | 92 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 12: No change | 7 Patients |
| Ranibizumab: Re-treated Once | Number of Patients in Different Categories of Changes From Baseline in BCVA | Month 12: Worsening | 29 Patients |
Comparison: Change from baseline in BCVA: Improved vs. No change. For retreated subjects, the last scheduled assessment prior to the first retreatment was considered. For subjects treated only once, the last scheduled assessment available was considered.p-value: 0.004995% CI: [0.25, 0.91]Regression, Logistic
Comparison: Change from baseline in BCVA: Worsened vs. No changep-value: 0.046195% CI: [0.69, 44.52]Regression, Logistic
Primary
Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters
Improvement in BCVA \< 10 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA \< 10 letters (Yes/No) which was reported as Gain \>= 10 letters versus Gain \< 10 letters. For retreated patients, Gain \>= 10 letters and Gain \< 10 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab with improvement in BCVA \< 10 letters from baseline to that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 1: Gain >= 10 letters | 13 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 1: Gain < 10 letters | 38 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 2: Gain >= 10 letters | 20 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 2: Gain < 10 letters | 30 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 3: Gain >= 10 letters | 22 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 3: Gain < 10 letters | 30 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 6: Gain >= 10 letters | 29 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 6: Gain < 10 letters | 19 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 12: Gain >= 10 letters | 28 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 12: Gain < 10 letters | 23 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 6: Gain < 10 letters | 42 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 1: Gain >= 10 letters | 27 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 3: Gain < 10 letters | 53 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 1: Gain < 10 letters | 70 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 12: Gain < 10 letters | 44 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 2: Gain >= 10 letters | 40 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 6: Gain >= 10 letters | 50 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 2: Gain < 10 letters | 55 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 12: Gain >= 10 letters | 48 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters | Month 3: Gain >= 10 letters | 41 Patients |
Comparison: Gain \< 10 letters vs. Gain \>= 10 letters.p-value: 0.011495% CI: [1.23, 5.17]Regression, Logistic
Primary
Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters
Improvement in BCVA \< 5 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA \< 5 letters (Yes/No) which was reported as Gain \>= 5 letters versus Gain \< 5 letters. For retreated patients, Gain \>= 5 letters and Gain \< 5 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab with improvement in BCVA \< 5 letters from baseline at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 1: Gain >= 5 letters | 37 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 1: Gain < 5 letters | 14 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 2: Gain >= 5 letters | 38 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 2: Gain < 5 letters | 12 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 3: Gain >= 5 letters | 37 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 3: Gain < 5 letters | 15 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 6: Gain >= 5 letters | 40 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 6: Gain < 5 letters | 8 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 12: Gain >= 5 letters | 43 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 12: Gain < 5 letters | 8 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 6: Gain < 5 letters | 22 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 1: Gain >= 5 letters | 69 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 3: Gain < 5 letters | 20 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 1: Gain < 5 letters | 28 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 12: Gain < 5 letters | 23 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 2: Gain >= 5 letters | 70 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 6: Gain >= 5 letters | 70 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 2: Gain < 5 letters | 25 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 12: Gain >= 5 letters | 69 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters | Month 3: Gain >= 5 letters | 74 Patients |
Comparison: Gain \< 5 letters vs. Gain \>= 5 letters.p-value: 0.085495% CI: [0.9, 5.33]Regression, Logistic
Primary
Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage
Presence of active leakage on fluorescein angiography (FAG) was assessed at screening (14 to 3 days before baseline visit), month 2 and month 6. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of active leakage (Yes/No). For retreated patients, the presence/absence of active leakage was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable
Time frame: Screening, Month 2, Month 6
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent fluorescein angiography at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening: Active leakage, No | 3 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening: Active leakage, Yes | 61 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening: Active leakage, NE | 0 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening: Active leakage, Missing | 0 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 2: Active leakage, No | 58 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 2: Active leakage, Yes | 3 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 2: Active leakage, NE | 0 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 6: Active leakage, No | 55 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 6: Active leakage, Yes | 4 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 6: Active leakage, NE | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 6: Active leakage, No | 73 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening: Active leakage, No | 0 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 2: Active leakage, Yes | 56 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening: Active leakage, Yes | 121 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 6: Active leakage, NE | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening: Active leakage, NE | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 2: Active leakage, NE | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Screening: Active leakage, Missing | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 6: Active leakage, Yes | 40 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage | Month 2: Active leakage, No | 61 Patients |
Comparison: Presence vs. absence of active leakage.p-value: <0.000195% CI: [23.44, 223.42]Regression, Logistic
Primary
Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities
Presence of clinically significant abnormalities was assessed at baseline, month 1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of clinically significant abnormalities (Yes/No). For retreated patients, the presence/absence of clinically significant abnormalities was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent ocular examination during that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 1: Clinically Significant Abnorma, No | 60 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 3: Clinically Significant Abnormal, No | 56 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Baseline: Clinically Significant Abnormal, Yes | 9 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 1: Clinically Significant Abnormal, Yes | 6 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 3: Clinically Significant Abnormal, Missing | 7 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Baseline: Clinically Significant Abnormal, No | 61 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 6: Clinically Significant Abnormal, No | 59 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 1: Clinically Significant Abnormal, Missing | 4 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 6: Clinically Significant Abnormal, Yes | 3 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 2: Clinically Significant Abnormal, No | 60 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 6: Clinically Significant Abnormal, Missing | 8 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Baseline: Clinically Significant Abnormal, Missing | 0 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 12: Clinically Significant Abnormal, No | 61 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 2: Clinically Significant Abnormal, Yes | 5 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 12: Clinically Significant Abnormal, Yes | 2 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 3: Clinically Significant Abnormal, Yes | 7 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 12: Clinically Significant Abnormal, Missing | 7 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 2:Clinically Significant Abnormal, Missing | 5 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 12: Clinically Significant Abnormal, Missing | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Baseline: Clinically Significant Abnormal, No | 103 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Baseline: Clinically Significant Abnormal, Yes | 27 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Baseline: Clinically Significant Abnormal, Missing | 0 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 1: Clinically Significant Abnorma, No | 106 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 1: Clinically Significant Abnormal, Yes | 24 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 2: Clinically Significant Abnormal, No | 103 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 2: Clinically Significant Abnormal, Yes | 26 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 2:Clinically Significant Abnormal, Missing | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 3: Clinically Significant Abnormal, No | 108 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 3: Clinically Significant Abnormal, Yes | 20 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 3: Clinically Significant Abnormal, Missing | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 6: Clinically Significant Abnormal, No | 110 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 6: Clinically Significant Abnormal, Yes | 18 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 6: Clinically Significant Abnormal, Missing | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 12: Clinically Significant Abnormal, No | 116 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 12: Clinically Significant Abnormal, Yes | 12 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities | Month 1: Clinically Significant Abnormal, Missing | 0 Patients |
Comparison: Presence vs. absence of clinically significant abnormalities.p-value: 0.010395% CI: [1.58, 30.23]Regression, Logistic
Primary
Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts
Presence of cysts from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of cysts (Yes/No). For retreated patients, the presence/absence of cysts was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable
Time frame: Screening, Month 2, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Screening: Cysts, No | 41 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 6: Cysts, No | 57 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 2: Cysts, No | 60 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 6: Cysts, Yes | 2 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 2: Cysts, Yes | 2 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 6: Cysts, NE | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Screening: Cysts, Yes | 27 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 12: Cysts, No | 57 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 2: Cysts, NE | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 12: Cysts, Yes | 3 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Screening: Cysts, NE | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 12: Cysts, NE | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 2: Cysts, Missing | 0 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 12: Cysts, NE | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 2: Cysts, No | 94 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Screening: Cysts, No | 79 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Screening: Cysts, NE | 0 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 2: Cysts, Yes | 32 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 2: Cysts, NE | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 2: Cysts, Missing | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 6: Cysts, No | 98 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 6: Cysts, Yes | 27 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 6: Cysts, NE | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 12: Cysts, No | 97 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Month 12: Cysts, Yes | 26 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts | Screening: Cysts, Yes | 50 Patients |
Comparison: Presence vs. absence of cysts.p-value: <0.000195% CI: [3.76, 42.67]Regression, Logistic
Primary
Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid
Presence of Intra-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of Intra-retinal fluid (Yes/No). For retreated patients, the presence/absence of Intra-retinal fluid was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable
Time frame: Screening, Month 2, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Screening: Intra-retinal fluid, NE | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 6: Intra-retinal fluid, No | 57 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Screening: Intra-retinal fluid, No | 19 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 6: Intra-retinal fluid, Yes | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 2: Intra-retinal fluid, No | 55 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 6: Intra-retinal fluid, NE | 2 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 12: Intra-retinal fluid, NE | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 12: Intra-retinal fluid, No | 58 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 2: Intra-retinal fluid, Yes | 7 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 12: Intra-retinal fluid, Yes | 2 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Screening: Intra-retinal fluid, Yes | 49 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 2: Intra-retinal fluid, NE | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 12: Intra-retinal fluid, NE | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Screening: Intra-retinal fluid, No | 37 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Screening: Intra-retinal fluid, NE | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 2: Intra-retinal fluid, No | 77 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 2: Intra-retinal fluid, Yes | 50 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 2: Intra-retinal fluid, NE | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 6: Intra-retinal fluid, No | 85 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 6: Intra-retinal fluid, Yes | 38 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 6: Intra-retinal fluid, NE | 3 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 12: Intra-retinal fluid, No | 96 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Month 12: Intra-retinal fluid, Yes | 26 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid | Screening: Intra-retinal fluid, Yes | 90 Patients |
Comparison: Presence vs. absence of intra-retinal fluid.p-value: <0.000195% CI: [11.62, 213.5]Regression, Logistic
Primary
Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema
Presence of macular edema from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of macular edema (Yes/No). For retreated patients, the presence/absence of macular edema was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. \*NE = Not evaluable
Time frame: Screening, Month 2, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Screening: Macular Edema, Yes | 28 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 6: Macular Edema, No | 57 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 2: Macular Edema, No | 59 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 6: Macular Edema, Yes | 2 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Screening: Macular Edema, No | 38 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 6: Macular Edema, NE | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 2: Macular Edema, Yes | 3 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 12: Macular Edema, No | 56 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 12: Macular Edema, Yes | 4 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Screening: Macular Edema, NE | 3 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 12: Macular Edema, NE | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 2: Macular Edema, NE | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 12: Macular Edema, NE | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Screening: Macular Edema, No | 63 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Screening: Macular Edema, Yes | 65 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Screening: Macular Edema, NE | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 2: Macular Edema, No | 103 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 2: Macular Edema, Yes | 24 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 2: Macular Edema, NE | 2 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 6: Macular Edema, No | 101 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 6: Macular Edema, Yes | 24 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 6: Macular Edema, NE | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 12: Macular Edema, Yes | 15 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema | Month 12: Macular Edema, No | 108 Patients |
Comparison: Presence vs. absence of macular edema.p-value: <0.000195% CI: [3.18, 27.36]Regression, Logistic
Primary
Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid
Presence of sub-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. The regression model for sub-retinal fluid was not valid because Yes was reported in almost all subjects causing a quasi-complete separation of data points. \*NE = Not evaluable
Time frame: Screening, Month 2, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Screening: Sub-retinal fluid, No | 43 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Screening: Sub-retinal fluid, Yes | 25 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Screening: Sub-retinal fluid, NE | 1 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 2: Sub-retinal fluid, No | 58 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 2: Sub-retinal fluid, Yes | 2 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 2: Sub-retinal fluid, NE | 3 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 6: Sub-retinal fluid, No | 58 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 6: Sub-retinal fluid, Yes | 0 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 6: Sub-retinal fluid, NE | 2 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 12: Sub-retinal fluid, No | 60 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 12: Sub-retinal fluid, Yes | 0 Patients |
| Ranibizumab: Treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 12: Sub-retinal fluid, NE | 1 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 12: Sub-retinal fluid, Yes | 8 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Screening: Sub-retinal fluid, No | 65 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 6: Sub-retinal fluid, No | 109 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Screening: Sub-retinal fluid, Yes | 61 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 12: Sub-retinal fluid, No | 113 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Screening: Sub-retinal fluid, NE | 3 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 6: Sub-retinal fluid, Yes | 14 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 2: Sub-retinal fluid, No | 108 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 12: Sub-retinal fluid, NE | 3 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 2: Sub-retinal fluid, Yes | 17 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 6: Sub-retinal fluid, NE | 3 Patients |
| Ranibizumab: Re-treated Once | Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid | Month 2: Sub-retinal fluid, NE | 4 Patients |
Secondary
Change in Patient Quality of Life From Baseline to Month 2 and Month 12
Patient quality of life was assessed by Impact of Vision Impairment (IVI) questionnaire. IVI is a 32-item instrument, either self- or interviewer-administered, developed to measure the impact of vision impairment on daily activities in five domains. The 32 items were divided into 5 domains as follows: Leisure and work (items 1 to 5), Social and consumer interaction (items 6 to 10 and items 23-24), Household and personal care (items 11 to 14 and items 20-21), Mobility (items 15 to 19 and item 22), Emotional reaction to vision loss (items 25 to 32). Responses to the IVI items were rated on a five-category Likert scale: not at all, 0; hardly at all, 1; a little, 2; a fair amount, 3; a lot, 4; and can't do because of eyesight, 5. Total score was an arithmetic average of the items rated between 0 (the best score) and 5 (the worst score). A negative change indicates improvement. Data was computed on items with non missing response
Time frame: Baseline, Month 2, Month 12
Population: Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab with data at both timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab: Treated Once | Change in Patient Quality of Life From Baseline to Month 2 and Month 12 | Change at Month 2 | -0.40 units on a scale | Standard Deviation 0.68 |
| Ranibizumab: Treated Once | Change in Patient Quality of Life From Baseline to Month 2 and Month 12 | Change at month 12 | -0.54 units on a scale | Standard Deviation 0.91 |
| Ranibizumab: Re-treated Once | Change in Patient Quality of Life From Baseline to Month 2 and Month 12 | Change at Month 2 | -0.15 units on a scale | Standard Deviation 0.6 |
| Ranibizumab: Re-treated Once | Change in Patient Quality of Life From Baseline to Month 2 and Month 12 | Change at month 12 | -0.36 units on a scale | Standard Deviation 0.81 |
Secondary
Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 6 and Month 12 on Study Eye
Change from baseline in BCVA (Best Corrected Visual Acuity) was Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score. Patients with a BCVA ETDRS letter score of 78 to 24 in the study eye were included; A higher score represents better functioning of the study eye. A positive change from baseline shows improvement.
Time frame: Baseline, Month 6, Month 12
Population: Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab. The study eyes of the patients belonging to the FAS were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab: Treated Once | Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 6 and Month 12 on Study Eye | Change at 6 month | 7.51 letters | Standard Deviation 11.68 |
| Ranibizumab: Treated Once | Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 6 and Month 12 on Study Eye | Change at 12 month | 8.42 letters | Standard Deviation 12.81 |
Secondary
Mean Number of Ranibizumab Injection
Mean number of ranibizumab injection is reported as number of injections per patient.
Time frame: Baseline to Month 12
Population: Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab: Treated Once | Mean Number of Ranibizumab Injection | 2.41 injections | Standard Deviation 1.53 |
Secondary
Number of Patients Having Ocular and/or Systemic Adverse Event (AE)
Number of patients with any systemic AE, with serious systemic AE, with an ocular AE, with an ocular serious AE are reported
Time frame: Baseline to Month 12
Population: Safety Population: all subjects who received at least one dose of ranibizumab and had at least one post-baseline safety assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab: Treated Once | Number of Patients Having Ocular and/or Systemic Adverse Event (AE) | Ocular Adverse Event | 41 Patients |
| Ranibizumab: Treated Once | Number of Patients Having Ocular and/or Systemic Adverse Event (AE) | Ocular serious adverse event | 2 Patients |
| Ranibizumab: Treated Once | Number of Patients Having Ocular and/or Systemic Adverse Event (AE) | Any systemic Adverse Event | 30 Patients |
| Ranibizumab: Treated Once | Number of Patients Having Ocular and/or Systemic Adverse Event (AE) | Serious systemic Adverse Event | 5 Patients |
Secondary
Time to Re-treatment
Time to re-treatment, defined as time in months from the data of first dose of ranibizumab to the date of re-treatment, was evaluated.
Time frame: Baseline to Month 12
Population: Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab: Treated Once | Time to Re-treatment | 2.56 Months | Standard Deviation 2.17 |