Age-related Macular Degeneration (AMD) Clinical Trial
Official title:
Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)
Verified date | December 2021 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This was the cross-sectional study to assess the 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.
Status | Completed |
Enrollment | 369600 |
Est. completion date | December 11, 2020 |
Est. primary completion date | December 11, 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 (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: - =1 HCPCS code (J code) or NDC code for treatment with brolucizumab in 2019 |
Country | Name | City | State |
---|---|---|---|
United States | Novartis Investigative Site | East Hanover | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
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 (excluding brolucizumab) 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 (excluding brolucizumab) 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 (excluding brolucizumab) 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 (excluding brolucizumab) 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 (excluding brolucizumab) 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 |
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