Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05146687
Collaborator
(none)
369,600
1
4.9
75501.3

Study Details

Study Description

Brief Summary

This was the cross-sectional study to assess the period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019.

Condition or Disease Intervention/Treatment Phase
  • Other: Aflibercept
  • Other: Ranibizumab
  • Other: Bevacizumab

Detailed Description

In this cross-sectional study of patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab), evidence was generated to describe the period prevalence of specific ocular AEs. The study was conducted using the Komodo Healthcare Map, and all results were based on the study period from 01/01/2018 to 12/31/2019.

Komodo Healthcare Map data from 01/01/2018 to 12/31/2019 for patients with a diagnosis of wet AMD who were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.

  • Identification period: Patients fulfilling the selection criteria during the period from 01/01/2019 to 12/31/2019 were identified

  • Index date: 01/01/2019

  • Study Period: 01/01/2018 to 12/31/2019

  • Pre-index period: 01/01/2018 to 12/31/2018

  • Post-index period: 01/01/2019 to 12/31/2019

Study Design

Study Type:
Observational
Actual Enrollment :
369600 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)
Actual Study Start Date :
Jul 15, 2020
Actual Primary Completion Date :
Dec 11, 2020
Actual Study Completion Date :
Dec 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Aflibercept

Patients/patient eyes who were treated only with aflibercept in 2019

Other: Aflibercept
intravitreal injection
Other Names:
  • EYLEA®
  • Ranibizumab

    Patients/patient eyes who were treated only with ranibizumab in 2019

    Other: Ranibizumab
    intravitreal injection
    Other Names:
  • LUCENTIS®
  • Bevacizumab

    Patients/patient eyes who were treated only with bevacizumab in 2019

    Other: Bevacizumab
    intravitreal injection
    Other Names:
  • AVASTIN®; off-label use
  • ≥2 Different Anti- VEFGFs

    Patients/patient eyes who were treated with ≥2 different anti-VEGFs in 2019

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents [earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019]

      Period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019 was assessed.

    Secondary Outcome Measures

    1. Age [earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019]

      Age information was reported

    2. Gender information [earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019]

      Gender information was reported

    3. Number of patients at various Patient Region [earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019]

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

    4. Number of patients with Insurance type [earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019]

      Private, Medicare, Medicare Advantage, Medicaid, Other

    5. Number of patients with Laterality of wet Age-related macular degeneration (AMD) [Index date (defined as the date of first injection - 01/01/2019)]

      Laterality of wet AMD: Unilateral, Bilateral

    6. Number of patient eyes with the Provider specialty on date of first anti-VEGF injection [earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019]

      The following types were included: Retina specialist, General ophthalmologist

    7. Number of patient eyes treated with anti-VEGF agent [Index date (defined as the date of first injection - 01/01/2019)]

      The following types were included OD [eye, right], OS [eye, left], Unspecified

    8. Number of anti-VEGF injections [over a one-year period from 01/012019 to 31/12/2019]

      Anti-VEGF utilization in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab) over a one-year period was assessed. Measured at the patient level and patient-eye level.

    9. Number of patients with other ocular AEs in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab) [over a one-year period from 01/012019 to 31/12/2019]

      The following types were included: Key ocular AEs IOI events RVO events Unspecified RO Autoimmune disorders (systemic lupus erythematosus [SLE], Behcet's disease, sarcoidosis, VKH disease, HLA-B27 syndromes, Drug hypersensitivity) RV without RO (RAO and/or RVO)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in 2019

    • ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) code for treatment with an anti-VEGF agent (excluding brolucizumab) in 2019

    • ≥18 years old in 2019

    • ≥2 wet AMD-related office visits in 2019

    Exclusion Criteria:
    • ≥1 HCPCS code (J code) or NDC code for treatment with brolucizumab in 2019

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site East Hanover New Jersey United States 07936-1080

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05146687
    Other Study ID Numbers:
    • CRTH258AUS19
    First Posted:
    Dec 7, 2021
    Last Update Posted:
    Dec 16, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2021