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

October 6, 2021 updated by: Novartis Pharmaceuticals
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Index date defined as the date of enrollment in the PSS program
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
Time Frame: Index date defined as the date of enrollment in the PSS program
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
Time Frame: Index date defined as the date of enrollment in the PSS program
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)
Time Frame: Index date defined as the date of enrollment in the PSS program
Distribution of patients across US states
Index date defined as the date of enrollment in the PSS program
Provider region (by state)
Time Frame: Index date defined as the date of enrollment in the PSS program
Number of providers and their distribution across US states
Index date defined as the date of enrollment in the PSS program
Insurance coverage
Time Frame: Index date defined as the date of enrollment in the PSS program
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
Time Frame: Index date defined as the date of enrollment in the PSS program
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
Time Frame: Index date defined as the date of enrollment in the PSS program
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

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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