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)

Age-related Macular Degeneration (AMD) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110209
• Other study ID #: CRTH258AUS20
• Status: Completed
• Start date: July 15, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: December 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331541
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration (AMD)
• Macular Degeneration

Intervention

Other:
• Aflibercept
intravitreal injection
• Ranibizumab
intravitreal injection
• Bevacizumab
intravitreal injection

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Age	Age information was reported	earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Secondary	Gender information	Gender information was reported	earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Secondary	Number of patients at various Patient Region	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
Secondary	Number of patients with Insurance type	Private, Medicare, Medicare Advantage, Medicaid, Other	earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Secondary	Number of patients with Laterality of wet Age-related macular degeneration (AMD)	Laterality of wet AMD: Unilateral, Bilateral	Index date (defined as the date of first injection - 01/01/2019)
Secondary	Number of patient eyes with the Provider specialty on date of first anti-VEGF injection	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
Secondary	Number of patient eyes treated with anti-VEGF agent	The following types were included OD [eye, right], OS [eye, left], Unspecified	Index date (defined as the date of first injection - 01/01/2019)
Secondary	Number of anti-VEGF injections	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
Secondary	Number of patients with other ocular AEs in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab)	The following types were included: Key ocular AEs; IOI events; RVO events; Unspecified RO; Autoimmune disorders (systemic lupus erythematosus [SLE], Behcet's disease, sarcoidosis, VKH disease, HLA-B27 syndromes, Drug hypersensitivity); RV without RO (RAO and/or RVO)	over a one-year period from 01/012019 to 31/12/2019

External Links

•   Results for CRTH258AUS20 from the Novartis Clinical Trials Website