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)

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.

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration (AMD)
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 369600

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study included patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Laterality of wet Age-related macular degeneration (AMD)	Laterality of wet AMD: Unilateral, Bilateral	Index date (defined as the date of first injection - 01/01/2019)
Number of patient eyes treated with anti-VEGF agent	The following types were included OD [eye, right], OS [eye, left], Unspecified	Index date (defined as the date of first injection - 01/01/2019)
Number of patients with other ocular AEs in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab)	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)	over a one-year period from 01/012019 to 31/12/2019
Age	Age information was reported	earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Gender information	Gender information was reported	earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patients at various Patient Region	Patient regions: Northeast, Midwest, South, West, Unknown	earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patients with Insurance type	Private, Medicare, Medicare Advantage, Medicaid, Other	earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of patient eyes with the Provider specialty on date of first anti-VEGF injection	The following types were included: Retina specialist, General ophthalmologist	earliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019
Number of anti-VEGF injections	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.	over a one-year period from 01/012019 to 31/12/2019

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CRTH258AUS19 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2020
• Primary Completion (ACTUAL): December 11, 2020
• Study Completion (ACTUAL): December 11, 2020

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (ACTUAL): December 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: treatment-naive; AMD,; brolucizumab,; anti-VEGF switchers,
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab; Bevacizumab; Aflibercept
• Other Study ID Numbers: CRTH258AUS19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No