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

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 IRIS Registry.

Detailed Description
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IRIS Registry EHR 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 was identified Index date: Defined as the date of the earliest brolucizumab injection Study Period: The period from the first patient eye exposure to brolucizumab to the last follow-up recorded Pre-index period: The period 36 months prior to the index date. Data within 36 months prior to the index date will be used to assess baseline characteristics. Post-index period: The period 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) (IRIS 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: ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or EMR note for treatment with brolucizumab during the index period (date of earliest code or EMR note = index date) ≥18 years old on the index date ≥1 Current Procedural Terminology (CPT) code for intravitreal administration 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 o Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US. ≥1 follow-up visit after the index date ≥1 VA assessment on the index date or within 90 days prior to the index date Exclusion Criteria: Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials) Unknown laterality of the index eye on 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 | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Gender information | Gender information was reported | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Number of patients at various Patient Region | Patient regions: Northeast, Midwest, South, West, Unknown | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Number of patients with Insurance type | Insurance type: Medicare, Medicare Advantage, Medicaid, Commercial, Government, Military, No Insurance, Miscellaneous, Unknown | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Number of patients with Laterality of wet Age-related macular degeneration (AMD) | Laterality of wet AMD: Unilateral, Bilateral | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Race/Ethnicity of the participants (patient level and eye level) | Caucasian, Black or African American, Asian, Other, Unknown | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| 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 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 Concomitant ocular medications | Types: Corticosteroids Prednisone Prednisolone acetate Difluprednate Biologics Cyclosporine Methotrexate Ganciclovir Acyclovir Trifluridine Rituxan | 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 history of ocular inflammation | 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-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 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 the Provider specialty | The following types were included: Retina specialist, General ophthalmologist, Non-retina specialist, unknown | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Number of patient eyes with the previous ocular surgeries or procedures | The following categories were included: Laser therapy Laser coagulation Photodynamic therapy IOP lowering surgeries (lasers, glaucoma filtering, non-filtering glaucoma) Cataract surgery Iridotomy Intraocular or refractive surgery (almost all IOP & cataract surgeries) Previous penetrating keratoplasty, vitrectomy, or ocular radiation Previous panretinal photocoagulation Previous submacular surgery, other surgical intervention or laser treatment for AMD | 6 months prior to the index date ( index date defined as the date of first brolucizumab injection) | 
| Number of eyes treated with brolucizumab | The following types were included: OD [eye, right], OS [eye, left], Unspecified, Unilateral, Bilateral) | At the brolucizumab index date defined as the date of first brolucizumab injection | 
| Number of patient eyes with Visual Acuity (VA) reading | The following categories were included: Snellen: 20/10, 20/12-20/20, 20/25-20/40, 20/50-20/160, ≤20/200 Approximate ETDRS letters | At the brolucizumab index date defined as the date of first brolucizumab injection with lookback of 365 days | 
| 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 | 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 prior treatment status | The following types were included: off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive | 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 different prior anti-VEGF agents | The following categories were measured at the eye level: 0, 1, 2, ≥3 | 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 prior anti-VEGF injections | Total, per anti-VEGF agent were measured at the eye level) Continuous Categorical: <6, 6 to <12, 12 to <24, ≥24 | 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection) | 
| Duration of last anti-VEGF treatment | Total, per anti-VEGF agent; will be measured at the eye level All anti-VEGFs i. Continuous ii. Categorical: <6, 6 to <12, 12 to <24, ≥24 months Specific anti-VEGF iii. Continuous iv. Categorical: <6, 6 to <12, 12 to <24, ≥24 months | 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 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 (among switchers) | The following categories were measured: Continuous (days) Categorical (0-30, 31-60, 61-90, 91+ days) | At the brolucizumab 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,, visual acuity