Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)

Study Overview
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Brief Summary
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This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the Komodo Healthcare Map.

Detailed Description
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Komodo Healthcare Map claims data from 08-Oct-2016 to the date of most recent data from patients with wet AMD who initiated brolucizumab were analyzed in this study. Identification period of the index date (index period): The patients fulfilling the selection criteria were identified during the period from 08-Oct-2019 to 30-Apr-2020. Index date: Defined as the date of the earliest brolucizumab injection during the index period. Study Period: The period from 08-Oct-2016 to the most recent data extraction date (05-Jun-2020). o Note since 05-Jun-2020 was the date data was pulled, claims data from recent months (e.g. May) may be incomplete (relative to the final DB state) as well. Pre-index period: The period 36 months prior to the index date o Note: Data within 36 months prior to the index date will be used to assess baseline characteristics. Post-index period: The period of 180 days after the index date

Official Title
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Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)

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: ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) for treatment with brolucizumab during the index period (date of earliest code = index date) ≥18 years old on the index date ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in the 36 months prior to or on the index date Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US ≥24 months of continuous enrollment prior to the index date ≥1 follow-up visit related to their wet AMD after the index date Exclusion criteria: Use of brolucizumab prior to 08-Oct-2019 (e.g. clinical trials) Unknown laterality of the index eye on the index date Patients with no data throughout the 12 months immediately prior to the index date

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 patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months | To assess IOI events observed after starting treatment with brolucizumab | Up to 6 months post brolucizumab injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age information was reported | Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) | 
| Gender information | Gender information was reported | Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) | 
| Number of patients at various Patient Region | Patient regions: Northeast, Midwest, South, West, Unknown | Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) | 
| Number of patients with Insurance type | Insurance type: Private, Medicare, Medicare Advantage, Medicaid, Other | Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) | 
| Number of patients with Laterality of wet Age-related macular degeneration (AMD) | Laterality of wet AMD: Unilateral, Bilateral | Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) | 
| Number of patients with Laterality of any Age-related macular degeneration (AMD) | Laterality of wet AMD: Unilateral, Bilateral | Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) | 
| Number of eyes with the concurrent eye disease | Types of concurrent eye diseases: Cataracts Posterior vitreous detachment Puckering of macula Macular hole Vitreomacular traction Glaucoma Amblyopia Papillitis Ischemic optic atrophy Diabetic retinopathy Diabetic macular edema Hypertensive retinopathy Pathologic myopia RAO RO RV Vitritis Endophthalmitis Uveitis Choroidal neovascularization (due to causes other than AMD, if possible, to determine) IOI | Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with previous ocular surgeries or procedures | Types: Laser photocoagulation (or laser therapy) Photodynamic therapy (PDT) Glaucoma surgery (trabeculectomy, MIGS) Cataract surgery Iridotomy Ocular radiation Panretinal photocoagulation Submacular surgery, other surgical intervention or laser treatment for AMD Vitrectomy Scleral buckle Pneumatic retinopexy Cryopexy | Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with systemic comorbidities | Types: Obesity Cerebrovascular disease Peripheral vascular disease Diabetes Renal disease Chronic pulmonary disease Congestive heart failure Any malignancy, including lymphoma and leukemia Myocardial infarction Dementia Arteriothrombotic event Thromboembolytic event Atherosclerosis Arterial hypertension Ischemic heart disease Atrial fibrillation Lipid disorders Cardiac septal defect Valvular cardiac defect Hyperlipidemia Hypercholesterolemia Atherosclerotic disease Thrombosis Carotid artery disease | 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Number of Concomitant systemic medications (chronic use) | Types: Corticosteroids Systemic anti-VEGFs Lipid lowering agents Antihypertensives Biologics Antimetabolites/cancer therapy Anticoagulants | 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with the Cataract status | Types: phakic, pseudophakic, aphakic | 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with Intraocular inflammation | The following categories were reported: No history of IOI and endophthalmitis related to safety evaluation and panuveitis History of IOI and endophthalmitis related to safety evaluation and panuveitis History of IOI including panuveitis (excluding endophthalmitis related to safety evaluation) History of endophthalmitis related to safety evaluation History of panuveitis | 12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with the history of ocular inflammation (includes IOIs or panuveitis or endophthalmitis relevant to safety evaluation) | The following categories were reported: History of anterior inflammation History of posterior inflammation No history of IOI or endophthalmitis related to safety evaluation or panuveitis History of IOI and/or endophthalmitis related to safety evaluation and/or panuveitis History of IOI including panuveitis (excluding endophthalmitis related to safety evaluation) History of endophthalmitis related to safety evaluation History of Panuveitis | 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| History of other IOI and endophthalmitis due to infections or other underlying disease | The following categories were reported: No history of inflammation History of any ocular inflammation History of severe ocular inflammation History of anterior inflammation History of posterior inflammation History of IOI or endophthalmitis due to infections and other underlying disease (separate category) | 36, 12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO) | Included history of ocular inflammation or occlusion | 12 months prior to the index date ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with Systemic inflammation / auto-immune history (in total and at the event level) | The following categories were reported: Systemic vasculitis Rheumatoid arthritis SLE Multiple sclerosis Sarcoidosis Giant cell arteritis / Temporal arteritis HLA-B27 diseases Behcet/Behcet's disease Ankylosing Spondylitis Crohn Disease Drug Hypersensitivity Vogt-Koyanagi-Harada (VKH) | 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with the Provider specialty | The following types were included: Retina specialist, General ophthalmologist, Non-retina specialist, unknown | Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) | 
| Number of patient eyes with Concomitant ocular medications | The following types were included: any corticosteroids [prednisone, prednisolone acetate, difluprednate, Kenalog, ozurdex, yutiq], biologics [adalimumab], cyclosporine, azathioprine, methotrexate, ganciclovir, acyclovir, valacyclovir, foscavir, trifluridine, mycophenolate, rituxan, vancomycin, prostaglandins | 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Type of exam performed | OCT, FA, CP - color photo or color fundus photo | 30 days before or on first brolucizumab injection (index date) | 
| Number of eyes treated with brolucizumab | The following types were included: OD [eye, right], OS [eye, left], Unspecified, Unilateral, Bilateral) | Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020) | 
| Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated | Anti-VEGF treatment-naive vs prior-treated were measured at the eye-level | 60 months prior to index ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with prior treatment status | The following types were included: off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive | 60 months prior to index ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with different prior anti-VEGF agents | Following categories will be included : 0, 1, 2, ≥3 | 60 months prior to index ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with prior anti-VEGF agents (total, per anti-VEGF agent) | Following categories will be included : Continuous Categorical: <6, 6 to <12, 12 to <24, ≥24 | 60 months prior to index ( index date defined as the date of first brolucizumab injection) | 
| Number of patient eyes with the Last injection inetrval | Following categories will be included : Continuous (weeks) Categorical: <4, 4 to <6, 6 to <8, ≥8, <12, ≥12 weeks | 60 months prior to index ( index date defined as the date of first brolucizumab injection) | 
| Duration of last anti-VEGF treatment (total, per anti-VEGF agent) | Following categories will be included : All anti-VEGFs i. Continuous ii. Categorical: <6, 6 to <12, 12 to <24, ≥24 months Specific anti-VEGF iii. Continuous (days) | 60 months prior to index ( index date defined as the date of first brolucizumab injection) | 
| Time since wet Age-related macular degeneration (AMD) diagnosis | Patients were measured at the eye level | 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Time since any Age-related macular degeneration (AMD) diagnosis | Patients were measured at the eye level | 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Time from last anti-VEGF injection to index date | The following categories were measured: Continuous (days) Categorical (0-30, 31-60, 61-90, 91+ days) | 60 months prior to index ( index date defined as the date of first brolucizumab injection) | 
| Number of ocular adverse events (AEs) | To assess the incidence of ocular AEs among patients treated with brolucizumab | Post-index period defined as the 180 days following therapy initiation, excluding index date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brolucizumab,, intravitreal injection,, neovascular age-related macular degeneration