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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05110209
Other study ID # CRTH258AUS20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date November 20, 2020

Study information

Verified date December 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 331541
Est. completion date November 20, 2020
Est. primary completion date November 20, 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 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Aflibercept
intravitreal injection
Ranibizumab
intravitreal injection
Bevacizumab
intravitreal injection

Locations

Country Name City State
United States Novartis Investigative Site East Hanover New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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 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 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 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 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 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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