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Completed

NCT Number: NCT05110209

Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Agerelated Macular Degeneration (AMD) Who Received Anti-VEGF Agents (IRIS Registry)

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 IRIS Registry, and all results were based on the study period from 01/01/2019 to 12/31/2019.

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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, 07936-1080, United States

About this study

This was a retrospective cohort study of eyes in adult patients with a diagnosis of wet AMD who were treated with anti-VEGF agents from 01/01/2019 to 12/31/2019.

IRIS Registry data from 01/01/2019 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: 01/01/2019 to 12/31/2019
  • Pre-index period: 01/01/2018 to 12/31/2018
  • Post-index period: 01/01/2019 to 12/31/2019

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥1 International Classification of Diseases, Clinical Modification-9/10 CM (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

  • Patient eyes that received >1 type of anti-VEGF treatment on the same date
  • Patient eyes that did not have laterality any time during 2018-2019
  • Treatment with brolucizumab during 2019

Treatment and study plan

Aflibercept

Other

intravitreal injection

Other names: EYLEA®

Ranibizumab

Other

intravitreal injection

Other names: LUCENTIS®

Bevacizumab

Other

intravitreal injection

Other names: AVASTIN®; off-label use

Primary outcomes

  1. Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents

    Time frame: 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 outcomes

  1. Age

    Time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019

    Age information was reported

  2. Gender information

    Time frame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019

    Gender information was reported

  3. Number of patients at various Patient Region

    Time frame: earliest claim of anti-VEGF injection 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

    Time frame: earliest claim of anti-VEGF injection 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)

    Time frame: 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

    Time frame: earliest claim of anti-VEGF injection 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 5, 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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