A Retrospective, 12-month, Multicenter Study to Evaluate Real-world Brolucizumab Effectiveness and Safety in Japanese Patients With Neovascular Age-related Macular Degeneration (nAMD) - the PHEASANT Study - a Study Following the Master Protocol

简要总结

主要结局

次要结局

• Clinical Characteristic: Time Between Diagnosis and First Brolucizumab Injection(Baseline)
• Clinical Characteristic: Time Between Diagnosis and First Treatment(Baseline)
• Demographic: Number of Patients per Age Category(Baseline)
• Demographic: Gender(Baseline)
• Number of Patients per Clinical Characteristic(Baseline)
• Clinical Characteristic: Central Subfield Thickness (CSFT)(Baseline)
• Clinical Characteristic: Visual Acuity (VA)(Baseline)
• Clinical Characteristic: VA in Each Subtype(Baseline)
• Number of Patients by Type of Previous Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment(Up to 12 months pre-baseline)
• Last Injection Interval of Anti-VEGF Treatment Before Switching(Up to 12 months pre-baseline)
• Number of Injections in the Last 6 Months Before Switching to Brolucizumab(Up to 6 months pre-baseline)
• Number of Injections in the Last 6 Months After Switching to Brolucizumab(Up to 6 months post-baseline)
• Number of Injections in the Last 12 Months Before Switching to Brolucizumab(Up to 12 months pre-baseline)
• Number of Injections in the Last 12 Months After Switching to Brolucizumab(Up to 12 months post-baseline)
• Number of Patients With Absence of Subretinal Fluid (SRF)(Month 3, 6, 9, 12 and 18)
• Number of Patients with Absence of Intra-retinal Fluid (IRF)(Month 3, 6, 9, 12, and 18)
• Number of Patients with Absence of Sub-retinal Pigment Epithelium (sub-RPE) Fluid(Month 3, 6, 9, 12, and 18)
• Number of Patients with Absence of SRF and IRF(Month 3, 6, 9, 12, and 18)
• Number of Patients with Absence of IRF, SRF, and sub-RPE Fluid(Month 3, 6, 9, 12, and 18)
• Demographic: Age(Baseline)
• Time to Absence of Retinal Fluid During the First Year of Treatment Among Those With Presence of Retinal Fluid at Baseline(12 months)
• Central Subfield Thickness (CFST) at Month 3, 6, 9, 12 and 18(Month 3, 6, 9, 12, and 18)
• Change in CFST From Baseline to Months 3, 6, 9, 12, and 18(Baseline, Month 3, 6, 9, 12, and 18)
• VA Change in Each Subtype From Baseline to Month 3(Baseline, Month 3)
• VA Change in Each Subtype From Baseline to Month 6(Baseline, Month 6)
• VA Change in Each Subtype From Baseline to Month 9(Baseline, Month 9)
• VA Change in Each Subtype From Baseline to Month 12(Baseline, Month 12)
• VA Change in Each Subtype From Baseline to Month 18(Baseline, Month 18)
• Number of Brolucizumab Injections During the Study Within Specified Time Intervals(Up to 18 months)
• Number of Non-injection Visits During Treatment With Brolucizumab Within Specified Time Intervals(Up to 18 months)
• Number of Visits During Treatment With Brolucizumab Within Specified Time Intervals(Up to 18 months)
• Number of Patients Categorized by Injection Intervals During Months 0 to 6(From Month 0 to Month 6)
• Number of Patients Categorized by Injection Intervals During Months 0 to 12(From Month 0 to Month 12)
• Number of Patients Categorized by Injection Intervals During Months 0 to 18(From Month 0 to Month 18)
• Number of Patients Categorized by Injection Intervals During Months 13 to 18(From Month 13 to Month 18)
• Number of Patients With a Change in Injection Interval at Month 12(Month 12)
• Number of Patients With Prophylactic Administration of Steroid Eye Drops Within Specified Time Intervals(Up to 18 months)
• Number of Visits With Optical Coherence Tomography (OCT) Within Specified Time Intervals(Up to 18 months)
• Number of Visits Without OCT Within Specified Time Intervals(Up to 18 months)
• Predictive Variables of VA Change From Baseline to Month 12(Baseline, Month 12)
• Number of Patients Categorized by Criteria for Re-treatment(Month 3, 6, 9, 12, and 18)
• Number of Patients Categorized by Criteria for No Re-treatment(Month 3, 6, 9, 12, and 18)
• Number of Patients who Switched to Another Anti-VEGF During Treatment With Brolucizumab Within Specified Time Intervals(Up to 18 months)
• Number of Patients who Discontinued Treatment During the First Year(Up to 12 months)
• Number of Patients by Reason for Discontinuing Brolucizumab Treatment(Up to 12 months)
• Number of Patients With Adverse Events (AEs)(Up to 12 months)
• Number of Patients With Adverse Events of Special Interest (AESIs) and by Type of AESI(Up to 12 months)
• Number of AEs and AESIs per Patients(Up to 12 months)
• Number of Patients With AEs Categorized by Age and Gender(Up to 12 months)
• Number of Patients With AESIs Categorized by Age and Gender(Up to 12 months)
• Number of Patients With Brolucizumab-related AEs and AESIs(Up to 12 months)
• Number or Patients Who's AEs and AESIs Resolved(Up to 12 months)
• Number of Resolved AEs and AESIs(Up to 12 months)
• Time From First Brolucizumab Injection to AESIs(Up to 12 months)
• Best Corrected Visual Acuity (BCVA)(Up to 12 months)