A Phase 3 interventional study of Ranibizumab in Choroidal Neovascularization Secondary to Pathologic Myopia, sponsored by Novartis Pharmaceuticals. Completed at 31 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-18.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
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EXCLUSION CRITERIA:
Patients treated with a single ranibizumab 0.5 mg/0.05ml intravitreal injection
Drug: Ranibizumab
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.
Also known as: RFB002
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
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
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
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
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
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
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
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
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
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
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
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
Mean Number of Ranibizumab Injection
Mean number of ranibizumab injection is reported as number of injections per patient.
Time frame: Baseline to Month 12
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
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
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
| Milestone | Ranibizumab |
|---|---|
| Started | 200 |
| Once treated patients | 70 |
| Re-treated patients | 130 |
| Completed | 186 |
| Not completed | 14 |
| Withdrew: Withdrawal by subject | 7 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Death | 1 |
| Withdrew: Pregnancy | 1 |
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
| Patients | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Screening: Active leakage, No | 3 | 0 |
| Screening: Active leakage, Yes | 61 | 121 |
| Screening: Active leakage, NE | 0 | 2 |
| Screening: Active leakage, Missing | 0 | 1 |
| Month 2: Active leakage, No | 58 | 61 |
| Month 2: Active leakage, Yes | 3 | 56 |
| Month 2: Active leakage, NE | 0 | 2 |
| Month 6: Active leakage, No | 55 | 73 |
| Month 6: Active leakage, Yes | 4 | 40 |
| Month 6: Active leakage, NE | 1 | 2 |
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.
| letters | Ranibizumab |
|---|---|
| Change at 6 month | 7.51 ± 11.68 |
| Change at 12 month | 8.42 ± 12.81 |
Mean number of ranibizumab injection is reported as number of injections per patient.
| injections | Ranibizumab |
|---|---|
| Mean Number of Ranibizumab Injection | 2.41 ± 1.53 |
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.
| Months | Ranibizumab: Re-treated Once |
|---|---|
| Time to Re-treatment | 2.56 ± 2.17 |
Number of patients with any systemic AE, with serious systemic AE, with an ocular AE, with an ocular serious AE are reported
| Patients | Ranibizumab |
|---|---|
| Any systemic Adverse Event | 30 |
| Serious systemic Adverse Event | 5 |
| Ocular Adverse Event | 41 |
| Ocular serious adverse event | 2 |
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
| units on a scale | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Change at Month 2 | -0.40 ± 0.68 | -0.15 ± 0.60 |
| Change at month 12 | -0.54 ± 0.91 | -0.36 ± 0.81 |
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
| Patients | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Screening: Macular Edema, No | 38 | 63 |
| Screening: Macular Edema, Yes | 28 | 65 |
| Screening: Macular Edema, NE | 3 | 1 |
| Month 2: Macular Edema, No | 59 | 103 |
| Month 2: Macular Edema, Yes | 3 | 24 |
| Month 2: Macular Edema, NE | 1 | 2 |
| Month 6: Macular Edema, No | 57 | 101 |
| Month 6: Macular Edema, Yes | 2 | 24 |
| Month 6: Macular Edema, NE | 1 | 1 |
| Month 12: Macular Edema, No | 56 | 108 |
| Month 12: Macular Edema, Yes | 4 | 15 |
| Month 12: Macular Edema, NE | 1 | 1 |
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
| Patients | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Screening: Cysts, No | 41 | 79 |
| Screening: Cysts, Yes | 27 | 50 |
| Screening: Cysts, NE | 1 | 0 |
| Month 2: Cysts, No | 60 | 94 |
| Month 2: Cysts, Yes | 2 | 32 |
| Month 2: Cysts, NE | 1 | 2 |
| Month 2: Cysts, Missing | 0 | 1 |
| Month 6: Cysts, No | 57 | 98 |
| Month 6: Cysts, Yes | 2 | 27 |
| Month 6: Cysts, NE | 1 | 1 |
| Month 12: Cysts, No | 57 | 97 |
| Month 12: Cysts, Yes | 3 | 26 |
| Month 12: Cysts, NE | 1 | 1 |
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
| Patients | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Screening: Intra-retinal fluid, No | 19 | 37 |
| Screening: Intra-retinal fluid, Yes | 49 | 90 |
| Screening: Intra-retinal fluid, NE | 1 | 2 |
| Month 2: Intra-retinal fluid, No | 55 | 77 |
| Month 2: Intra-retinal fluid, Yes | 7 | 50 |
| Month 2: Intra-retinal fluid, NE | 1 | 2 |
| Month 6: Intra-retinal fluid, No | 57 | 85 |
| Month 6: Intra-retinal fluid, Yes | 1 | 38 |
| Month 6: Intra-retinal fluid, NE | 2 | 3 |
| Month 12: Intra-retinal fluid, No | 58 | 96 |
| Month 12: Intra-retinal fluid, Yes | 2 | 26 |
| Month 12: Intra-retinal fluid, NE | 1 | 2 |
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.
| micromilimeter(um) | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Month 2 Vs. Screening : CSFT | -16.15 ± 86.65 | -34.28 ± 78.01 |
| Month 6 Vs. Month 2: CSFT | -11.04 ± 61.06 | -15.83 ± 70.74 |
| Month 12 Vs. Month 6: CSFT | 1.29 ± 62.55 | 8.64 ± 76.79 |
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.
| mm^3 | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Month 2 Vs. Screening : CSV | -0.02 ± 0.06 | -0.02 ± 0.06 |
| Month 6 Vs. Month 2: CSV | -0.00 ± 0.04 | -0.01 ± 0.07 |
| Month 12 Vs. Month 6: CSV | -0.00 ± 0.04 | 0.01 ± 0.08 |
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
| Patients | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Screening: Sub-retinal fluid, No | 43 | 65 |
| Screening: Sub-retinal fluid, Yes | 25 | 61 |
| Screening: Sub-retinal fluid, NE | 1 | 3 |
| Month 2: Sub-retinal fluid, No | 58 | 108 |
| Month 2: Sub-retinal fluid, Yes | 2 | 17 |
| Month 2: Sub-retinal fluid, NE | 3 | 4 |
| Month 6: Sub-retinal fluid, No | 58 | 109 |
| Month 6: Sub-retinal fluid, Yes | 0 | 14 |
| Month 6: Sub-retinal fluid, NE | 2 | 3 |
| Month 12: Sub-retinal fluid, No | 60 | 113 |
| Month 12: Sub-retinal fluid, Yes | 0 | 8 |
| Month 12: Sub-retinal fluid, NE | 1 | 3 |
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.
| Patients | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Baseline: Clinically Significant Abnormal, No | 61 | 103 |
| Baseline: Clinically Significant Abnormal, Yes | 9 | 27 |
| Baseline: Clinically Significant Abnormal, Missing | 0 | 0 |
| Month 1: Clinically Significant Abnorma, No | 60 | 106 |
| Month 1: Clinically Significant Abnormal, Yes | 6 | 24 |
| Month 1: Clinically Significant Abnormal, Missing | 4 | 0 |
| Month 2: Clinically Significant Abnormal, No | 60 | 103 |
| Month 2: Clinically Significant Abnormal, Yes | 5 | 26 |
| Month 2:Clinically Significant Abnormal, Missing | 5 | 1 |
| Month 3: Clinically Significant Abnormal, No | 56 | 108 |
| Month 3: Clinically Significant Abnormal, Yes | 7 | 20 |
| Month 3: Clinically Significant Abnormal, Missing | 7 | 2 |
| Month 6: Clinically Significant Abnormal, No | 59 | 110 |
| Month 6: Clinically Significant Abnormal, Yes | 3 | 18 |
| Month 6: Clinically Significant Abnormal, Missing | 8 | 2 |
| Month 12: Clinically Significant Abnormal, No | 61 | 116 |
| Month 12: Clinically Significant Abnormal, Yes | 2 | 12 |
| Month 12: Clinically Significant Abnormal, Missing | 7 | 2 |
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.
| Patients | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Month 1: Gain >= 5 letters | 37 | 69 |
| Month 1: Gain < 5 letters | 14 | 28 |
| Month 2: Gain >= 5 letters | 38 | 70 |
| Month 2: Gain < 5 letters | 12 | 25 |
| Month 3: Gain >= 5 letters | 37 | 74 |
| Month 3: Gain < 5 letters | 15 | 20 |
| Month 6: Gain >= 5 letters | 40 | 70 |
| Month 6: Gain < 5 letters | 8 | 22 |
| Month 12: Gain >= 5 letters | 43 | 69 |
| Month 12: Gain < 5 letters | 8 | 23 |
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.
| Patients | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Month 1: Gain >= 10 letters | 13 | 27 |
| Month 1: Gain < 10 letters | 38 | 70 |
| Month 2: Gain >= 10 letters | 20 | 40 |
| Month 2: Gain < 10 letters | 30 | 55 |
| Month 3: Gain >= 10 letters | 22 | 41 |
| Month 3: Gain < 10 letters | 30 | 53 |
| Month 6: Gain >= 10 letters | 29 | 50 |
| Month 6: Gain < 10 letters | 19 | 42 |
| Month 12: Gain >= 10 letters | 28 | 48 |
| Month 12: Gain < 10 letters | 23 | 44 |
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.
| Patients | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once |
|---|---|---|
| Month 1: No change | 7 | 18 |
| Month 1: Worsening | 8 | 15 |
| Month 1: Improvement | 51 | 97 |
| Month 2: No change | 6 | 9 |
| Month 2: Worsening | 9 | 25 |
| Month 2: Improvement | 50 | 95 |
| Month 3: No change | 3 | 9 |
| Month 3: Worsening | 8 | 25 |
| Month 3: Improvement | 52 | 94 |
| Month 6: No change | 5 | 6 |
| Month 6: Worsening | 9 | 30 |
| Month 6: Improvement | 48 | 92 |
| Month 12: No change | 3 | 7 |
| Month 12: Worsening | 9 | 29 |
| Month 12: Improvement | 51 | 92 |
Collected over Adverse events were collected from time of treatment until exit from the study (approximately 12 months). Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ranibizumab | — | 7/200 (3.5%) | 26/200 (13%) |
| Event | Ranibizumab |
|---|---|
| Expired product administered (Study Eye)Injury, poisoning and procedural complications | 2/200 |
| Atrioventricular blockCardiac disorders | 1/200 |
| Cardiac arrestCardiac disorders | 1/200 |
| Cholecystitis acuteHepatobiliary disorders | 1/200 |
| Klebsiella sepsisInfections and infestations | 1/200 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/200 |
| Ovarian cystReproductive system and breast disorders | 1/200 |
| Event | Ranibizumab |
|---|---|
| Choroidal neovascularisation (Study Eye)Eye disorders | 7/200 |
| InfluenzaInfections and infestations | 7/200 |
| Conjunctival hyperaemia (Both Eyes)Eye disorders | 5/200 |
| Conjunctival haemorrhage (Study Eye)Eye disorders | 4/200 |
| Ocular hypertension (Both Eyes)Eye disorders | 4/200 |
| Choroidal neovascularisation (Non-study Eye)Eye disorders | 3/200 |
Full Analysis Set (FAS): All subjects who received at least one dose of ranibizumab
| Age, Continuous(Years) | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once | Total |
|---|---|---|---|
| Mean | 61.27 ± 13.03 | 62.12 ± 12.52 | 61.82 ± 12.67 |
| Sex: Female, Male(Participants) | Ranibizumab: Treated Once | Ranibizumab: Re-treated Once | Total |
|---|---|---|---|
| Female | 53 | 94 | 147 |
| Male | 17 | 36 | 53 |
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals