NCT05037396

Brief Summary

This was a retrospective cohort study to assess the treatment history, demographic characteristics, clinical characteristics, and early treatment patterns of patients who received brolucizumab for neovascular age-related macular degeneration using IRIS Registry.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9,457

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

March 5, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

July 29, 2021

Last Update Submit

October 6, 2021

Conditions

Age-related Macular Degeneration (AMD)

Keywords

AMD,brolucizumab,anti-VEGF switchers,treatment-naive

Outcome Measures

Primary Outcomes (1)

  • Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months

    To describe anti-VEGF treatment status (naive or switcher) in patients with wet AMD who initiated brolucizumab

    Up to 4 months post brolucizumab injection

Secondary Outcomes (25)

  • Age information

    Index date

  • Gender information

    Index date

  • Number of participants: Regions

    12-month period prior to index

  • Number of participants: Insurance type

    12-month period prior to index

  • Number of participants: Laterality

    12-month period prior to index

  • +20 more secondary outcomes

Study Arms (1)

Brolucizumab

Participants received brolucizumab injection during the index period

Drug: Brolucizumab

Interventions

BrolucizumabDRUG

Participants received brolucizumab injection during the index period

Also known as: BEOVU®
Brolucizumab

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with wet AMD who initiated brolucizumab were analyzed in this study

You may qualify if:

  • Patients with ≥1 brolucizumab injection
  • Diagnosis of wet AMD (ICD-10: H35.3210, H35.3211, H35.3212, H35.3213, H35.3220, H35.3221, H35.3222, H35.3223, H35.3230, H35.3231, H35.3232, H35.3233, H35.3290, H35.3291, H35.3292, and H35.3293) on the index date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigational site

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

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

brolucizumab

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

July 29, 2021

First Posted

September 8, 2021

Study Start

March 5, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)