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)

NCT ID: NCT05110209

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

331541 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2020-11-20

Brief Summary

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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.

Detailed Description

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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

Conditions

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Age-related Macular Degeneration (AMD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Aflibercept

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

Aflibercept

Intervention Type OTHER

intravitreal injection

Ranibizumab

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

Ranibizumab

Intervention Type OTHER

intravitreal injection

Bevacizumab

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

Bevacizumab

Intervention Type OTHER

intravitreal injection

≥2 Different Anti- VEFGFs

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

No interventions assigned to this group

Interventions

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Aflibercept

intravitreal injection

Intervention Type OTHER

Ranibizumab

intravitreal injection

Intervention Type OTHER

Bevacizumab

intravitreal injection

Intervention Type OTHER

Other Intervention Names

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EYLEA® LUCENTIS® AVASTIN®; off-label use

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17877

Results for CRTH258AUS20 from the Novartis Clinical Trials Website

Other Identifiers

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CRTH258AUS20

Identifier Type: -

Identifier Source: org_study_id