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)

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Age-related Macular Degeneration (AMD)

Intervention / Treatment
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* Other: Aflibercept
* Other: Ranibizumab
* Other: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aflibercept<br>Patients/patient eyes who were treated only with aflibercept in 2019 | Other: Aflibercept<br>* intravitreal injection<br>* Other names: EYLEA®;|
| Ranibizumab<br>Patients/patient eyes who were treated only with ranibizumab in 2019 | Other: Ranibizumab<br>* intravitreal injection<br>* Other names: LUCENTIS®;|
| Bevacizumab<br>Patients/patient eyes who were treated only with bevacizumab in 2019 | Other: Bevacizumab<br>* intravitreal injection<br>* Other names: AVASTIN®; off-label use;|
| ≥2 Different Anti- VEFGFs<br>Patients/patient eyes who were treated with ≥2 different anti-VEGFs in 2019 | |

What is the study measuring?
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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 | 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 | Age information was reported | earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019 | 
| Gender information | 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 | 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 | 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) | 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 | 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 | 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 | 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) | 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 |