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Clinical Trials/NCT05037396
NCT05037396
Completed
Not Applicable

Treatment History, Demographic Characteristics, Clinical Characteristics, and Early Treatment Patterns of Patients Who Received Brolucizumab for Neovascular Age-related Macular Degeneration: IRIS Registry Study

Novartis Pharmaceuticals1 site in 1 country9,457 target enrollmentMarch 5, 2020

Overview

Phase
Not Applicable
Intervention
Brolucizumab
Conditions
Age-related Macular Degeneration (AMD)
Sponsor
Novartis Pharmaceuticals
Enrollment
9457
Locations
1
Primary Endpoint
Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months
Status
Completed
Last Updated
4 years ago

Overview

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.

Detailed Description

This was a retrospective cohort study of patients with wet AMD who received brolucizumab. Evidence was generated from the IRIS registry to describe patient treatment histories, demographic and clinical characteristics, and early treatment patterns. Setting and study population: IRIS Registry EHR data from 10/08/2018 to the 03/31/2020 from patients with wet AMD who initiated brolucizumab were analyzed. Identification period of the index date: The patients fulfilling the selection criteria identified during the period from 10/08/2019 to 03/31/2020. Index date: Defined as the date of the earliest brolucizumab injection. Study Period: The period from 10/08/2018 to 03/31/2020. Pre-index period: The period 12 months prior to the index date. Post-index period: The period 4 months after the index date (not a required selection criterion; only for the assessment of select endpoints in a subgroup of patients).

Registry
clinicaltrials.gov
Start Date
March 5, 2020
End Date
August 1, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • There were no exclusion criteria

Arms & Interventions

Brolucizumab

Participants received brolucizumab injection during the index period

Intervention: Brolucizumab

Outcomes

Primary Outcomes

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

Time Frame: Up to 4 months post brolucizumab injection

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

Secondary Outcomes

  • 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)
  • Number of participants: Concurrent eye disease(12-month period prior to index)
  • Number of participants: Provider specialty(At the brolucizumab index date defined as the date of first brolucizumab injection)
  • Encounter location (practice location)(At the brolucizumab index date defined as the date of first brolucizumab injection)
  • Eye location of brolucizumab injections(12-month period prior to index)
  • Index Visual acuity (VA)(At the brolucizumab index date defined as the date of first brolucizumab injection)
  • Number of participants: Race(12-month period prior to index)
  • Wet AMD diagnosis for the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
  • Visual acuity of the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
  • Number of prior anti-VEGF treatments(12-month period prior to index)
  • Type of prior anti-VEGF treatment among switchers to brolucizumab(12-month period prior to index)
  • Prior anti-VEGF treatment sequence(12-month period prior to index)
  • Number of prior anti-VEGF injections received prior to brolucizumab index date(12-month period prior to index)
  • Injection intervals for the eyes that had received anti-VEGF injections prior to index(12-month period prior to index)
  • The first injection interval after switch compared to last injection interval with a prior treatment(Up to 4 months post index date)
  • Type of anti-VEGF agent initiated after switching from index brolucizumab(First 3 months after switching from index brolucizumab)
  • Anti-VEGF treatment status for the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
  • Type of treatment for the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
  • The number of prior anti-VEGF treatments for the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
  • Number of brolucizumab injections received per study eye(Up to 4 months post index date)
  • The last injection interval(Up to 4 months post index date)

Study Sites (1)

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