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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Tracking Information
First Submitted Date October 22, 2021
First Posted Date November 8, 2021
Last Update Posted Date December 21, 2021
Actual Study Start Date June 17, 2020
Actual Primary Completion Date December 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2021)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 26, 2021)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
Official Title Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with wet AMD who initiated brolucizumab were analyzed in this study.
Condition Age-related Macular Degeneration (AMD)
Intervention Drug: Brolucizumab
Participants received brolucizumab injection during the index period
Other Name: BEOVU®
Study Groups/Cohorts Brolucizumab
Participants received brolucizumab injection during the index period
Intervention: Drug: Brolucizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 26, 2021)
9261
Original Actual Enrollment Same as current
Actual Study Completion Date December 18, 2020
Actual Primary Completion Date December 18, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05111743
Other Study ID Numbers CRTH258AUS21
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor Novartis Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date December 2021