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This retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-vascular endothelial growth factor (VEGF) and had ≥3 brolucizumab injections with no other anti-VEGF in the first 12 months (360 days) and 18 months (540 days) of follow-up respectively; and the 12-month and 18-month alternating (ALT) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-VEGF to brolucizumab and had ≥2 brolucizumab injections and ≥1 injection of another anti-VEGF in the first 12 months and 18 months of follow-up, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall cohort | |||
| 12-month BRO cohort | |||
| 18-month BRO cohort | |||
| 12-month ALT cohort | |||
| 18-month ALT cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in injection interval from first brolucizumab injection to Month 18 for BRO and ALT cohorts | Baseline, Month 18 | |
| Change in visual acuity (VA) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort) |
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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 |
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| Baseline, Months 12 and 18 |
| Change in central macular thickness (CMT) from first brolucizumab injection to Month 12 (for BRO and ALT cohorts) and Month 18 (for BRO cohort) | Baseline, Months 12 and 18 |
| Age | Baseline |
| Gender | Baseline |
| Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters) | Baseline, Month 12 and Month 18 |
| Anti-VEGF treatment status | Baseline |
| Last injection interval before switch to brolucizumab in prior-treated eyes | Baseline |
| Central macular thickness (CMT) | Baseline, Month 12 and Month 18 |
| Intraretinal fluid (IRF) | Baseline |
| Subretinal fluid (SRF) | Baseline |
| Pigment epithelial detachment (PED) | Baseline |
| Number of brolucizumab injections and non-brolucizumab injections from first brolucizumab injection to 12 months (for ALT cohort) | Baseline, Month 12 |
| Ocular adverse events (AEs) in eyes treated with at least one brolucizumab injection | Up to 3 years |
| Median time (days) from first brolucizumab injection to AE | Up to 3 years |
| Median time (days) from last brolucizumab injection pre-AE to AE | Up to 3 years |
| Median time (days) from AE to resolution | Up to 3 years |
| Median number of brolucizumab injections pre-AE including the index injection | Up to 3 years |
| Proportion of patients in different levels of vision recovery after AE resolution | Up to 3 years |