Characteristics of Patients With Neovascular Age-related Macular Degeneration Enrolled in the Brolucizumab Patient Support Services Program

The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program. Evidence was generated to describe their baseline demographic and clinical characteristics.

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration (AMD)
• Intervention / Treatment: Other: All participants

Detailed Description

The study was a retrospective, cross-sectional, descriptive study of patients with wet AMD who enrolled in the brolucizumab Patient Support Services (PSS) program.

PSS data was obtained from patients with wet AMD who enrolled in the program for the index period 10/10/2019 to 04/30/2020.

• Identification period of the index period: 10/10/2019 to 04/30/2020
• Index date: Date of enrollment in the PSS program
• Study Period: 10/10/2019 to 04/30/2020

• Study Type: Observational
• Enrollment (Actual): 18457

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study included patients with wet AMD

Description

Inclusion Criteria:

• Patients were enrolled in the brolucizumab PSS program
• ≥19 years old

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants; All the particpants enrolled in the brolucizumab Patient Support Services (PSS) program	Other: All participants; All the particpants enrolled in the brolucizumab Patient Support Services (PSS) program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Primary plan type	The primary plan type for patients with wet AMD enrolled in the brolucizumab patient support services program were reported. The primary Plan type include commercial, government or other insurance.	Index date defined as the date of enrollment in the PSS program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age information of patients enrolled in the brolucizumab PSS program was reported	Index date defined as the date of enrollment in the PSS program
Gender	Gender information of patients enrolled in the brolucizumab PSS program was reported	Index date defined as the date of enrollment in the PSS program
Patient region (by state)	Distribution of patients across US states	Index date defined as the date of enrollment in the PSS program
Provider region (by state)	Number of providers and their distribution across US states	Index date defined as the date of enrollment in the PSS program
Insurance coverage	The insurance coverage details for all the patients with wet AMD was reported	Index date defined as the date of enrollment in the PSS program
Number of patients with Secondary plan type	The secondary plan type for patients with wet AMD enrolled in the brolucizumab patient support services program were reported. The secondary plan included commercial, government or other insurance	Index date defined as the date of enrollment in the PSS program
Disease Status	The eye disease status of all the patients were reported. Disease status was categorized as Right eye, left eye, or bilateral	Index date defined as the date of enrollment in the PSS program

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CRTH258AUS18 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 11, 2020
• Primary Completion (ACTUAL): September 25, 2020
• Study Completion (ACTUAL): September 25, 2020

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (ACTUAL): October 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: brolucizumab; Primary plan,; AMD characteristics,
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: CRTH258AUS18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No