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NCT Number: NCT05082415

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

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.

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Key information

Conditions

Age-related Macular Degeneration (AMD) Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936-1080, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brolucizumab

Drug

Participants received brolucizumab injection during the index period

Other names: BEOVU®

Primary outcomes

  1. Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months

    Time frame: Up to 6 months post brolucizumab injection

    To assess IOI events observed after starting treatment with brolucizumab

Secondary outcomes

  1. Age

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

    Age information was reported

  2. Gender information

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

    Gender information was reported

  3. Number of patients at various Patient Region

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

    Patient regions: Northeast, Midwest, South, West, Unknown

  4. Number of patients with Insurance type

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

    Insurance type: Medicare, Medicare Advantage, Medicaid, Commercial, Government, Military, No Insurance, Miscellaneous, Unknown

  5. Number of patients with Laterality of wet Age-related macular degeneration (AMD)

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

    Laterality of wet AMD: Unilateral, Bilateral

  6. Race/Ethnicity of the participants (patient level and eye level)

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

    Caucasian, Black or African American, Asian, Other, Unknown

  7. Number of eyes with the concurrent eye disease

    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)

    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

  8. Number of patient eyes with cataract status

    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)

    Types: phakic, pseudophakic, aphakic

  9. Number of patient eyes with Concomitant ocular medications

    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)

    Types:

    • Corticosteroids
    • Prednisone
    • Prednisolone acetate
    • Difluprednate
    • Biologics
    • Cyclosporine
    • Methotrexate
    • Ganciclovir
    • Acyclovir
    • Trifluridine
    • Rituxan

  10. Number of patient eyes with the history of ocular inflammation

    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)

    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)

  11. Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)

    Time frame: 12 months prior to the index date ( index date defined as the date of first brolucizumab injection)

    Included history of ocular inflammation or occlusion

  12. Number of patient eyes with the Provider specialty

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

    The following types were included:

    Retina specialist, General ophthalmologist, Non-retina specialist, unknown

  13. Number of patient eyes with the previous ocular surgeries or procedures

    Time frame: 6 months prior to the index date ( index date defined as the date of first brolucizumab injection)

    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

  14. Number of eyes treated with brolucizumab

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

    The following types were included:

    OD [eye, right], OS [eye, left], Unspecified, Unilateral, Bilateral)

  15. Number of patient eyes with Visual Acuity (VA) reading

    Time frame: At the brolucizumab index date defined as the date of first brolucizumab injection with lookback of 365 days

    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

  16. Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated

    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)

    Anti-VEGF treatment-naive vs prior-treated were measured at the eye level

  17. Number of patient eyes with the prior treatment status

    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)

    The following types were included:

    off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive

  18. Number of different prior anti-VEGF agents

    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)

    The following categories were measured at the eye level:

    0, 1, 2, ≥3

  19. Number of prior anti-VEGF injections

    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)

    Total, per anti-VEGF agent were measured at the eye level)

    • Continuous
    • Categorical: <6, 6 to <12, 12 to <24, ≥24

  20. Duration of last anti-VEGF treatment

    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)

    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

  21. Time since wet Age-related macular degeneration (AMD) diagnosis

    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)

    Patients were measured at the eye level

  22. Time since any Age-related macular degeneration (AMD) diagnosis

    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)

    Patients were measured at the eye level

  23. Time from last anti-VEGF injection to index date (among switchers)

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

    The following categories were measured:

    • Continuous (days)
    • Categorical (0-30, 31-60, 61-90, 91+ days)

  24. Number of ocular adverse events (AEs)

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

    To assess the incidence of ocular AEs among patients treated with brolucizumab

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2021
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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