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

Age-related Macular Degeneration (AMD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05066685
• Other study ID #: CRTH258AUS18
• Status: Completed
• Start date: August 11, 2020
• Est. completion date: September 25, 2020

Study information

• Verified date: October 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18457
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients were enrolled in the brolucizumab PSS program

• =19 years old

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Age-related Macular Degeneration (AMD)
• Macular Degeneration

Intervention

Other:
• All participants
All the particpants enrolled in the brolucizumab Patient Support Services (PSS) program

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 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	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
Secondary	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
Secondary	Patient region (by state)	Distribution of patients across US states	Index date defined as the date of enrollment in the PSS program
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Results for CRTH258AUS18 from the Novartis Clinical Trials Website