Clinical trial NCT05110209: 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)
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration (AMD)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 331541
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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.

* 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents
timeFrame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Secondary outcomes:
measure: Age
timeFrame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
measure: Gender information
timeFrame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
measure: Number of patients at various Patient Region
timeFrame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
measure: Number of patients with Insurance type
timeFrame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
measure: Number of patients with Laterality of wet Age-related macular degeneration (AMD)
timeFrame: Index date (defined as the date of first injection - 01/01/2019)
measure: Number of patient eyes with the Provider specialty on date of first anti-VEGF injection
timeFrame: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
measure: Number of patient eyes treated with anti-VEGF agent
timeFrame: Index date (defined as the date of first injection - 01/01/2019)
measure: Number of anti-VEGF injections
timeFrame: over a one-year period from 01/012019 to 31/12/2019
measure: Number of patients with other ocular AEs in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab)
timeFrame: over a one-year period from 01/012019 to 31/12/2019
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: