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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)

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05146687
Enrollment
369600
Registered
2021-12-07
Start date
2020-07-15
Completion date
2020-12-11
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration (AMD)

Keywords

AMD,, brolucizumab,, anti-VEGF switchers,, treatment-naive

Brief summary

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.

Detailed description

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 Komodo Healthcare Map, and all results were based on the study period from 01/01/2018 to 12/31/2019. Komodo Healthcare Map data from 01/01/2018 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: 01/01/2018 to 12/31/2019 * Pre-index period: 01/01/2018 to 12/31/2018 * Post-index period: 01/01/2019 to 12/31/2019

Interventions

OTHERAflibercept

intravitreal injection

OTHERRanibizumab

intravitreal injection

OTHERBevacizumab

intravitreal injection

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agentsearliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019Period 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

MeasureTime frameDescription
Gender informationearliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019Gender information was reported
Number of patients at various Patient Regionearliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019Patient regions: Northeast, Midwest, South, West, Unknown
Number of patients with Insurance typeearliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019Private, 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
Ageearliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019Age information was reported
Number of patient eyes treated with anti-VEGF agentIndex 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 injectionsover a one-year period from 01/012019 to 31/12/2019Anti-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 31/12/2019The 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 patient eyes with the Provider specialty on date of first anti-VEGF injectionearliest claim of anti-VEGF injection (excluding brolucizumab) over a one-year period from 01/012019 to 31/12/2019The following types were included: Retina specialist, General ophthalmologist

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026