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

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ClinicalTrials.gov Identifier: NCT05111743
Recruitment Status : Completed
First Posted : November 8, 2021
Last Update Posted : December 21, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Age-related Macular Degeneration (AMD) Drug: Brolucizumab

Detailed Description:

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
Study Design
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Study Type : Observational
Actual Enrollment : 9261 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
Actual Study Start Date : June 17, 2020
Actual Primary Completion Date : December 18, 2020
Actual Study Completion Date : December 18, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Brolucizumab
Participants received brolucizumab injection during the index period
 Drug: Brolucizumab
Participants received brolucizumab injection during the index period
Other Name: BEOVU®


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with wet AMD who initiated brolucizumab were analyzed in this study.
Criteria

Inclusion criteria:

  1. ≥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)
  2. ≥18 years old on the index date

  3. ≥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
  4. ≥24 months of continuous enrollment prior to the index date
  5. ≥1 follow-up visit related to their wet AMD after the index date

Exclusion criteria:

  1. Use of brolucizumab prior to 08-Oct-2019 (e.g. clinical trials)
  2. Unknown laterality of the index eye on the index date
  3. Patients with no data throughout the 12 months immediately prior to the index date
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05111743


Locations
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United States, New Jersey
Novartis Investigative Site
East Hanover, New Jersey, United States, 79361080
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05111743    
Other Study ID Numbers: CRTH258AUS21
First Posted: November 8, 2021    Key Record Dates
Last Update Posted: December 21, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Brolucizumab,
intravitreal injection,
neovascular age-related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases