Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up

Study Overview
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Brief Summary
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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.

Official Title
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Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up

Conditions
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Neovascular Age-related Macular Degeneration

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of nAMD. Patients were on a previous anti-VEGF therapy and then switched to brolucizumab. Patients remained on brolucizumab for at least 12 months. Patients had exactly 360 days or more of follow-up after first brolucizumab injection. For BRO cohort only: Patients received at least three injections of brolucizumab during study period. For ALT cohort only: Patients received at least two injections of brolucizumab and one injection of another anti-VEGF during the study period. Exclusion Criteria: For BRO cohort only: Patients who received any other anti-VEGF therapy during the 12-month follow-up period. Eyes missing bilaterality information in their nAMD diagnosis. Eyes missing bilaterality information in their brolucizumab injections.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall cohort<br> | |
| 12-month BRO cohort<br> | |
| 18-month BRO cohort<br> | |
| 12-month ALT cohort<br> | |
| 18-month ALT cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in injection interval from baseline to Month 12 for BRO and ALT cohorts |  | Baseline, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nAMD