Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab

Study Overview
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Brief Summary
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This was a retrospective cohort study to assess the treatment history, demographic characteristics, clinical characteristics, and early treatment patterns of patients who received brolucizumab for neovascular age-related macular degeneration using IRIS Registry.

Detailed Description
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This was a retrospective cohort study of patients with wet AMD who received brolucizumab. Evidence was generated from the IRIS registry to describe patient treatment histories, demographic and clinical characteristics, and early treatment patterns. Setting and study population: IRIS Registry EHR data from 10/08/2018 to the 03/31/2020 from patients with wet AMD who initiated brolucizumab were analyzed. Identification period of the index date: The patients fulfilling the selection criteria identified during the period from 10/08/2019 to 03/31/2020. Index date: Defined as the date of the earliest brolucizumab injection. Study Period: The period from 10/08/2018 to 03/31/2020. Pre-index period: The period 12 months prior to the index date. Post-index period: The period 4 months after the index date (not a required selection criterion; only for the assessment of select endpoints in a subgroup of patients).

Official Title
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Treatment History, Demographic Characteristics, Clinical Characteristics, and Early Treatment Patterns of Patients Who Received Brolucizumab for Neovascular Age-related Macular Degeneration: IRIS Registry Study

Conditions
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Age-related Macular Degeneration (AMD)

Intervention / Treatment
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* Drug: Brolucizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ≥1 brolucizumab injection Diagnosis of wet AMD (ICD-10: H35.3210, H35.3211, H35.3212, H35.3213, H35.3220, H35.3221, H35.3222, H35.3223, H35.3230, H35.3231, H35.3232, H35.3233, H35.3290, H35.3291, H35.3292, and H35.3293) on the index date Exclusion Criteria: There were no exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Brolucizumab<br>Participants received brolucizumab injection during the index period | Drug: Brolucizumab<br>* Participants received brolucizumab injection during the index period<br>* Other names: BEOVU®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months | To describe anti-VEGF treatment status (naive or switcher) in patients with wet AMD who initiated brolucizumab | Up to 4 months post brolucizumab injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age information | Age information was reported | Index date | 
| Gender information | Gender information was reported | Index date | 
| Number of participants: Regions | Northeast, North Central, South, West, Unknown | 12-month period prior to index | 
| Number of participants: Insurance type | Private, Medicare, Medicare Advantage, Medicaid, Other | 12-month period prior to index | 
| Number of participants: Laterality | Unilateral, Bilateral | 12-month period prior to index | 
| Number of participants: Race | White, African American, Asian | 12-month period prior to index | 
| Number of participants: Concurrent eye disease | Participants were measured at the eye level for the following eye diseases: Cataracts, Posterior vitreous detachment, Epiretinal membrane, Macular hole, Vitreomacular traction, Amblyopia, Pseudophakia, Glaucoma, Diabetic macular edema, Retinal vein occlusion, Diabetic retinopathy, Myopic choroidal neovascularization | 12-month period prior to index | 
| Number of participants: Provider specialty | Participants were categorized based on provider specialty at date of first brolucizumab injection (e.g. Retina specialist, Ophthalmologist, etc) | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Encounter location (practice location) | Midwest, Northeast, South, West, Unknown | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Eye location of brolucizumab injections | e.g. OD [eye, right], OS [eye, left], Unspecified | 12-month period prior to index | 
| Index Visual acuity (VA) | Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters). Snellen VA ranges: 20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Wet AMD diagnosis for the fellow eye | Wet AMD diagnosis for the fellow eye as of the index date (Yes/No) | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Visual acuity of the fellow eye | Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters). Snellen VA ranges: 20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Number of prior anti-VEGF treatments | Number of anti-VEGF treatments used prior to brolucizumab at index by number of eyes were reported | 12-month period prior to index | 
| Type of prior anti-VEGF treatment among switchers to brolucizumab | Type of anti-VEGF agent (aflibercept, bevacizumab, ranibizumab, unlicensed bevacizumab) used immediately prior to index were reported | 12-month period prior to index | 
| Prior anti-VEGF treatment sequence | Prior treatment sequence(s) for previously treated eyes were reported. Continuous or Categorical (aflibercept, bevacizumab and ranibizumab) | 12-month period prior to index | 
| Number of prior anti-VEGF injections received prior to brolucizumab index date | Total and Per treatment prior anti-VEGF injections received prior to brolucizumab index date were reported | 12-month period prior to index | 
| Injection intervals for the eyes that had received anti-VEGF injections prior to index | Last injection interval, Average of last two injection intervals and Average of last three injection intervals were reported | 12-month period prior to index | 
| Anti-VEGF treatment status for the fellow eye | Anti-VEGF treatment endpoints for the fellow eyes with wet AMD (Naive, Switcher) were reported | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Type of treatment for the fellow eye | Following type of treatment for the fellow eye will be reported: aflibercept, bevacizumab, ranibizumab, brolucizumab, unlicensed bevacizumab, or none) | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| The number of prior anti-VEGF treatments for the fellow eye | Number of prior anti-VEGF injections for the fellow eye will be reported: Continuous or Categorical (e.g. 0, 1, ≥2) | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Number of brolucizumab injections received per study eye | Early treatment patterns after brolucizumab index date in anti-VEGF switcher and anti-VEGF naive patient eyes were reported | Up to 4 months post index date | 
| The last injection interval | The length of the interval between the final two injections was reported | Up to 4 months post index date | 
| The first injection interval after switch compared to last injection interval with a prior treatment | Longer, same or shorter interval were reported | Up to 4 months post index date | 
| Type of anti-VEGF agent initiated after switching from index brolucizumab | Thr type of anti-VEGF agent initiated in the first 3 months after switching from index brolucizumab. were reported | First 3 months after switching from index brolucizumab | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD,, brolucizumab,, anti-VEGF switchers,, treatment-naive