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Completed

NCT Number: NCT05111743

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

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.

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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 Investigative Site

East Hanover, New Jersey, 79361080, United States

About this study

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

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 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

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: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

    Age information was reported

  2. Gender information

    Time frame: 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 was reported

  3. Number of patients at various Patient Region

    Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

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

  4. Number of patients with Insurance type

    Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

    Insurance type: Private, Medicare, Medicare Advantage, Medicaid, Other

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

    Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

    Laterality of wet AMD: Unilateral, Bilateral

  6. Number of patients with Laterality of any Age-related macular degeneration (AMD)

    Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

    Laterality of wet AMD: Unilateral, Bilateral

  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 previous ocular surgeries or procedures

    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:

    • 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

  9. Number of patient eyes with systemic comorbidities

    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:

    • 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

  10. Number of Concomitant systemic medications (chronic use)

    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
    • Systemic anti-VEGFs
    • Lipid lowering agents
    • Antihypertensives
    • Biologics
    • Antimetabolites/cancer therapy
    • Anticoagulants

  11. Number of patient eyes with the 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

  12. Number of patient eyes with Intraocular inflammation

    Time frame: 12 and 6 months 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 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

  13. Number of patient eyes with the history of ocular inflammation (includes IOIs or panuveitis or endophthalmitis relevant to safety evaluation)

    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:

    • 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

  14. History of other IOI and endophthalmitis due to infections or other underlying disease

    Time frame: 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)

    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)

  15. 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

  16. Number of patient eyes with Systemic inflammation / auto-immune history (in total and at the event 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)

    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)

  17. Number of patient eyes with the Provider specialty

    Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

    The following types were included:

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

  18. 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)

    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

  19. Type of exam performed

    Time frame: 30 days before or on first brolucizumab injection (index date)

    OCT, FA, CP - color photo or color fundus photo

  20. Number of eyes treated with brolucizumab

    Time frame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)

    The following types were included:

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

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

    Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

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

  22. Number of patient eyes with prior treatment status

    Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

    The following types were included: off-label bevacizumab, ranibizumab, aflibercept, unknown, treatment-naive

  23. Number of patient eyes with different prior anti-VEGF agents

    Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

    Following categories will be included : 0, 1, 2, ≥3

  24. Number of patient eyes with prior anti-VEGF agents (total, per anti-VEGF agent)

    Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

    Following categories will be included :

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

  25. Number of patient eyes with the Last injection inetrval

    Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

    Following categories will be included :

    • Continuous (weeks)
    • Categorical: <4, 4 to <6, 6 to <8, ≥8, <12, ≥12 weeks

  26. Duration of last anti-VEGF treatment (total, per anti-VEGF agent)

    Time frame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)

    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)

  27. 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

  28. 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

  29. Time from last anti-VEGF injection to index date

    Time frame: 60 months prior to index ( 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)

  30. 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
Nov 8, 2021
Registry last updated
Dec 21, 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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