Clinical trial NCT05037396: Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab
Official title: Treatment History, Demographic Characteristics, Clinical Characteristics, and Early Treatment Patterns of Patients Who Received Brolucizumab for Neovascular Age-related Macular Degeneration: IRIS Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration (AMD)
Keywords: AMD,
brolucizumab,
anti-VEGF switchers,
treatment-naive
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 9457
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with wet AMD who initiated brolucizumab were analyzed in this study

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).

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

Primary outcomes:
measure: Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months
timeFrame: Up to 4 months post brolucizumab injection
Secondary outcomes:
measure: Age information
timeFrame: Index date
measure: Gender information
timeFrame: Index date
measure: Number of participants: Regions
timeFrame: 12-month period prior to index
measure: Number of participants: Insurance type
timeFrame: 12-month period prior to index
measure: Number of participants: Laterality
timeFrame: 12-month period prior to index
measure: Number of participants: Race
timeFrame: 12-month period prior to index
measure: Number of participants: Concurrent eye disease
timeFrame: 12-month period prior to index
measure: Number of participants: Provider specialty
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Encounter location (practice location)
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Eye location of brolucizumab injections
timeFrame: 12-month period prior to index
measure: Index Visual acuity (VA)
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Wet AMD diagnosis for the fellow eye
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Visual acuity of the fellow eye
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Number of prior anti-VEGF treatments
timeFrame: 12-month period prior to index
measure: Type of prior anti-VEGF treatment among switchers to brolucizumab
timeFrame: 12-month period prior to index
measure: Prior anti-VEGF treatment sequence
timeFrame: 12-month period prior to index
measure: Number of prior anti-VEGF injections received prior to brolucizumab index date
timeFrame: 12-month period prior to index
measure: Injection intervals for the eyes that had received anti-VEGF injections prior to index
timeFrame: 12-month period prior to index
measure: Anti-VEGF treatment status for the fellow eye
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Type of treatment for the fellow eye
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: The number of prior anti-VEGF treatments for the fellow eye
timeFrame: At the brolucizumab index date defined as the date of first brolucizumab injection
measure: Number of brolucizumab injections received per study eye
timeFrame: Up to 4 months post index date
measure: The last injection interval
timeFrame: Up to 4 months post index date
measure: The first injection interval after switch compared to last injection interval with a prior treatment
timeFrame: Up to 4 months post index date
measure: Type of anti-VEGF agent initiated after switching from index brolucizumab
timeFrame: First 3 months after switching from index brolucizumab
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigational site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: