NCT05066685

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,457

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

September 23, 2021

Last Update Submit

October 6, 2021

Conditions

Age-related Macular Degeneration (AMD)

Keywords

Primary plan,AMD characteristics,brolucizumab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Age

    Index date defined as the date of enrollment in the PSS program

  • Gender

    Index date defined as the date of enrollment in the PSS program

  • Patient region (by state)

    Index date defined as the date of enrollment in the PSS program

  • Provider region (by state)

    Index date defined as the date of enrollment in the PSS program

  • Insurance coverage

    Index date defined as the date of enrollment in the PSS program

  • +2 more secondary outcomes

Study Arms (1)

All Participants

All the particpants enrolled in the brolucizumab Patient Support Services (PSS) program

Other: All participants

Interventions

All participantsOTHER

All the particpants enrolled in the brolucizumab Patient Support Services (PSS) program

All Participants

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study included patients with wet AMD

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 4, 2021

Study Start

August 11, 2020

Primary Completion

September 25, 2020

Study Completion

September 25, 2020

Last Updated

October 12, 2021

Record last verified: 2021-10

Locations

US(1)