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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)

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Novartis

Status

Completed

Conditions

Age-related Macular Degeneration (AMD)

Treatments

Other: Bevacizumab
Other: Aflibercept
Other: Ranibizumab

Study type

Observational

Funder types

Industry

Identifiers

NCT05110209
CRTH258AUS20

Details and patient eligibility

About

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.

Full description

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

Enrollment

331,541 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

331,541 participants in 4 patient groups

Aflibercept
Description:
Patients/patient eyes who were treated only with aflibercept in 2019
Treatment:
Other: Aflibercept
Ranibizumab
Description:
Patients/patient eyes who were treated only with ranibizumab in 2019
Treatment:
Other: Ranibizumab
Bevacizumab
Description:
Patients/patient eyes who were treated only with bevacizumab in 2019
Treatment:
Other: Bevacizumab
≥2 Different Anti- VEFGFs
Description:
Patients/patient eyes who were treated with ≥2 different anti-VEGFs in 2019

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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