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A retrospective, observational, single-arm, non-randomized cohort study of ocular treatment in nAMD patients in Japan who had records of at least 12 months of follow-up after their first brolucizumab intravitreal injection. Patients who had records of at least 12 months of visits after the first brolucizumab injection (index date) were identified during the index period and were recruited during the data collection/recruitment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naive Group | Japanese patients diagnosed with nAMD who did not receive any anti-vascular endothelial growth factor (VEGF) injections during the 12 months before receiving brolucizumab. | ||
| Pre-treated Group | Japanese patients diagnosed with nAMD who received at least one injection of another anti-VEGF treatment during the 12 months before receiving brolucizumab. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Absence of Intra-retinal Fluid (IRF) and Absence of Subretinal Fluid (SRF) at Month 12 | Month 12 | |
| Number of Patients With Absence of IRF and Absence of SRF at Month 3, 6, 9, and 18 | Month 3, 6, 9, and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic: Age | Baseline | |
| Demographic: Number of Patients per Age Category | Age categories:
| Baseline |
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Inclusion criteria:
Exclusion criteria:
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This was a retrospective, noninterventional cohort study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | East Hanover | New Jersey | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40434532 | Derived | Ohnaka M, Sakurada Y, Hayashi A, Kadonosono K, Ohno H, Mori R, Matsumoto H, Nagamori I, Murata Y, Maio-Twofoot T, Karcher H, Takahashi H. Real-World Outcomes of Brolucizumab Treatment in Japanese Patients with Neovascular Age-Related Macular Degeneration: A 12-Month, Multicenter Study. Ophthalmol Ther. 2025 Jul;14(7):1551-1565. doi: 10.1007/s40123-025-01159-2. Epub 2025 May 28. |
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| Demographic: Gender | Baseline |
| Number of Patients per Clinical Characteristic | Clinical characteristics included:
| Baseline |
| Clinical Characteristic: Time Between Diagnosis and First Brolucizumab Injection | Baseline |
| Clinical Characteristic: Time Between Diagnosis and First Treatment | Baseline |
| Clinical Characteristic: Central Subfield Thickness (CSFT) | Baseline |
| Clinical Characteristic: Visual Acuity (VA) | Visual Acuity (VA) was measured with Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Conversion of VA readings to approximate ETDRS Letters:
| Baseline |
| Clinical Characteristic: VA in Each Subtype | VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded). | 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 |
| Time to Absence of Retinal Fluid During the First Year of Treatment Among Those With Presence of Retinal Fluid at Baseline | Retinal fluid categories included:
| 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 | VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded). | Baseline, Month 3 |
| VA Change in Each Subtype From Baseline to Month 6 | VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded). | Baseline, Month 6 |
| VA Change in Each Subtype From Baseline to Month 9 | VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded). | Baseline, Month 9 |
| VA Change in Each Subtype From Baseline to Month 12 | VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded). | Baseline, Month 12 |
| VA Change in Each Subtype From Baseline to Month 18 | VA was measured with ETDRS letters. Subtypes included CNV Type I, II, III, PCV (yes/no/not graded). | Baseline, Month 18 |
| Number of Brolucizumab Injections During the Study Within Specified Time Intervals | Time intervals included:
| Up to 18 months |
| Number of Non-injection Visits During Treatment With Brolucizumab Within Specified Time Intervals | Time intervals included:
| Up to 18 months |
| Number of Visits During Treatment With Brolucizumab Within Specified Time Intervals | Time intervals included:
| Up to 18 months |
| Number of Patients Categorized by Injection Intervals During Months 0 to 6 | Injection intervals (weeks) included:
| From Month 0 to Month 6 |
| Number of Patients Categorized by Injection Intervals During Months 0 to 12 | Injection intervals (weeks) included:
| From Month 0 to Month 12 |
| Number of Patients Categorized by Injection Intervals During Months 0 to 18 | Injection intervals (weeks) included:
| From Month 0 to Month 18 |
| Number of Patients Categorized by Injection Intervals During Months 13 to 18 | Injection intervals (weeks) included:
| From Month 13 to Month 18 |
| Number of Patients With a Change in Injection Interval at Month 12 | Changes in injection interval included:
| Month 12 |
| Number of Patients With Prophylactic Administration of Steroid Eye Drops Within Specified Time Intervals | Time intervals included:
| Up to 18 months |
| Number of Visits With Optical Coherence Tomography (OCT) Within Specified Time Intervals | Time intervals included:
| Up to 18 months |
| Number of Visits Without OCT Within Specified Time Intervals | Time intervals included:
| Up to 18 months |
| Predictive Variables of VA Change From Baseline to Month 12 | A multivariate regression model was used to assess the predictive value of VA change from baseline. Independent variables included age, baseline VA, baseline CNV activity, loading phase, VA (ETDRS letters) at the end of loading phase, CNV activity at the end of loading phase, PCV activity, number of injections, and geographic atrophy. | Baseline, Month 12 |
| Number of Patients Categorized by Criteria for Re-treatment | Re-treatment criteria included VA, anatomic parameters, VA and anatomic parameters, and posology requirement. | Month 3, 6, 9, 12, and 18 |
| Number of Patients Categorized by Criteria for No Re-treatment | No re-treatment criteria included general visits and check of brolucizumab related intraocular inflammation (IOI). | Month 3, 6, 9, 12, and 18 |
| Number of Patients who Switched to Another Anti-VEGF During Treatment With Brolucizumab Within Specified Time Intervals | Time intervals included:
| 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 | AESIs included endophthalmitis and Intraocular inflammation (IOI) including vasculitis and retinal vascular occlusion. | 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) | BCVA was assessed before AESI onset, during AESI, and after AESI recovery. BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or Snellen chart. | Up to 12 months |