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)

NCT05110209 | Completed

• 1 other identifier: CRTH258AUS20
• Study Type: observational
• Target: 331,541
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-related Macular Degeneration (AMD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Age

  earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019

• Gender information

  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

  earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019

• Number of patients with Insurance type

  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)

  Index date (defined as the date of first injection - 01/01/2019)

Study Arms (4)

Aflibercept

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

Other: Aflibercept

Ranibizumab

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

Other: Ranibizumab

Bevacizumab

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

Other: Bevacizumab

≥2 Different Anti- VEFGFs

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

Interventions

Aflibercept OTHER

intravitreal injection

Also known as: EYLEA®

Aflibercept

Ranibizumab OTHER

intravitreal injection

Also known as: LUCENTIS®

Ranibizumab

Bevacizumab OTHER

intravitreal injection

Also known as: AVASTIN®; off-label use

Bevacizumab

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CRTH258AUS20 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept; Ranibizumab; Bevacizumab; Off-Label Use

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Prescriptions; Drug Therapy; Therapeutics

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: July 15, 2020
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

US (1)