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)

Completed

• Conditions: Age-related Macular Degeneration (AMD)
• Interventions: Other: Aflibercept; Other: Ranibizumab; Other: Bevacizumab

• Registration Number: NCT05110209
• Lead Sponsor: Novartis Pharmaceuticals

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-15
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-05
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331541

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aflibercept	Aflibercept	Patients/patient eyes who were treated only with aflibercept in 2019
Ranibizumab	Ranibizumab	Patients/patient eyes who were treated only with ranibizumab in 2019
Bevacizumab	Bevacizumab	Patients/patient eyes who were treated only with bevacizumab in 2019

Primary Outcome Measures

Name	Time	Method
Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients with Laterality of wet Age-related macular degeneration (AMD)	Index date (defined as the date of first injection - 01/01/2019)	Laterality of wet AMD: Unilateral, Bilateral
Age	earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019	Age information was reported
Gender information	earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019	Gender information was reported
Number of patient eyes treated with anti-VEGF agent	Index date (defined as the date of first injection - 01/01/2019)	The following types were included OD \[eye, right\], OS \[eye, left\], Unspecified
Number of patients with other ocular AEs in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab)	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)
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	Patient regions: Northeast, Midwest, South, West, Unknown
Number of patients with Insurance type	earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019	Private, Medicare, Medicare Advantage, Medicaid, Other
Number of anti-VEGF injections	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.
Number of patient eyes with the Provider specialty on date of first anti-VEGF injection	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 East Hanover, New Jersey, United States