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

Novartis Pharmaceuticals9,456 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

9,456

Conditions

Age-related Macular Degeneration (AMD)

Interventions

BrolucizumabDRUG

Participants received brolucizumab injection during the index period

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥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) 2. ≥18 years old on the index date 3. ≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date 4. ≥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. 5. ≥1 follow-up visit after the index date 6. ≥1 VA assessment on the index date or within 90 days prior to the index date Exclusion Criteria: 1. Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials) 2. Unknown laterality of the index eye on the index date

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 6 months post brolucizumab injection

Secondary Outcomes

Age

Age information was reported

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

Gender information

Gender information was reported

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection

Data from ClinicalTrials.gov

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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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: Post-index period defined as the 180 days following therapy initiation, excluding index date