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)

December 15, 2021 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

331541

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

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
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.
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
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
earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
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
earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
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
earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
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
earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
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
Index date (defined as the date of first injection - 01/01/2019)
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
earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
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
Index date (defined as the date of first injection - 01/01/2019)
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.
over a one-year period from 01/012019 to 31/12/2019
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:

  1. Key ocular AEs
  2. IOI events
  3. RVO events
  4. Unspecified RO
  5. Autoimmune disorders (systemic lupus erythematosus [SLE], Behcet's disease, sarcoidosis, VKH disease, HLA-B27 syndromes, Drug hypersensitivity)
  6. RV without RO (RAO and/or RVO)
over a one-year period from 01/012019 to 31/12/2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2020

Primary Completion (Actual)

November 20, 2020

Study Completion (Actual)

November 20, 2020

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRTH258AUS20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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