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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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