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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
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Identification period: Patients fulfilling the selection criteria during the period from 01/01/2019 to 12/31/2019 were identified
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Index date: 01/01/2019
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Study Period: 01/01/2019 to 12/31/2019
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Pre-index period: 01/01/2018 to 12/31/2018
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Post-index period: 01/01/2019 to 12/31/2019
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Aflibercept Patients/patient eyes who were treated only with aflibercept in 2019 |
Other: Aflibercept
intravitreal injection
Other Names:
|
| Ranibizumab Patients/patient eyes who were treated only with ranibizumab in 2019 |
Other: Ranibizumab
intravitreal injection
Other Names:
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| Bevacizumab Patients/patient eyes who were treated only with bevacizumab in 2019 |
Other: Bevacizumab
intravitreal injection
Other Names:
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| ≥2 Different Anti- VEFGFs Patients/patient eyes who were treated with ≥2 different anti-VEGFs in 2019 |
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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
- 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
- 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 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 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: 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥1 International Classification of Diseases, Clinical Modification-9/10 CM (ICD- 9/10) code for wet AMD in 2019
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≥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
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≥18 years old in 2019
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≥2 wet AMD-related office visits in 2019
Exclusion Criteria:
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Patient eyes that received >1 type of anti-VEGF treatment on the same date
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Patient eyes that did not have laterality any time during 2018-2019
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Treatment with brolucizumab during 2019
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | East Hanover | New Jersey | United States | 07936-1080 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CRTH258AUS20