Clinical trial NCT05111743: Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
Official title: Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration (AMD)
Keywords: Brolucizumab,
intravitreal injection,
neovascular age-related macular degeneration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 9261
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 study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the Komodo Healthcare Map.

Detailed description: Komodo Healthcare Map claims data from 08-Oct-2016 to the date of most recent data from patients with wet AMD who initiated brolucizumab were analyzed in this study.

* Identification period of the index date (index period): The patients fulfilling the selection criteria were identified during the period from 08-Oct-2019 to 30-Apr-2020.
* Index date: Defined as the date of the earliest brolucizumab injection during the index period.
* Study Period: The period from 08-Oct-2016 to the most recent data extraction date (05-Jun-2020).

  o Note since 05-Jun-2020 was the date data was pulled, claims data from recent months (e.g. May) may be incomplete (relative to the final DB state) as well.
* Pre-index period: The period 36 months prior to the index date

  o Note: Data within 36 months prior to the index date will be used to assess baseline characteristics.
* Post-index period: The period of 180 days after the index date

Eligibility criteria: Inclusion criteria:

1. ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) for treatment with brolucizumab during the index period (date of earliest code = index date)
2. ≥18 years old on the index date
3. ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in the 36 months prior to or on the index date

   * Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US
4. ≥24 months of continuous enrollment prior to the index date
5. ≥1 follow-up visit related to their wet AMD after the index date

Exclusion criteria:

1. Use of brolucizumab prior to 08-Oct-2019 (e.g. clinical trials)
2. Unknown laterality of the index eye on the index date
3. Patients with no data throughout the 12 months immediately prior to the index date

Primary outcomes:
measure: Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months
timeFrame: Up to 6 months post brolucizumab injection
Secondary outcomes:
measure: Age
timeFrame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
measure: Gender information
timeFrame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
measure: Number of patients at various Patient Region
timeFrame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
measure: Number of patients with Insurance type
timeFrame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
measure: Number of patients with Laterality of wet Age-related macular degeneration (AMD)
timeFrame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
measure: Number of patients with Laterality of any Age-related macular degeneration (AMD)
timeFrame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
measure: Number of eyes with the concurrent eye disease
timeFrame: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with previous ocular surgeries or procedures
timeFrame: Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with systemic comorbidities
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of Concomitant systemic medications (chronic use)
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with the Cataract status
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with Intraocular inflammation
timeFrame: 12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with the history of ocular inflammation (includes IOIs or panuveitis or endophthalmitis relevant to safety evaluation)
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: History of other IOI and endophthalmitis due to infections or other underlying disease
timeFrame: 36, 12 and 6 months prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)
timeFrame: 12 months prior to the index date ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with Systemic inflammation / auto-immune history (in total and at the event level)
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with the Provider specialty
timeFrame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
measure: Number of patient eyes with Concomitant ocular medications
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Type of exam performed
timeFrame: 30 days before or on first brolucizumab injection (index date)
measure: Number of eyes treated with brolucizumab
timeFrame: Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020)
measure: Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated
timeFrame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with prior treatment status
timeFrame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with different prior anti-VEGF agents
timeFrame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with prior anti-VEGF agents (total, per anti-VEGF agent)
timeFrame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
measure: Number of patient eyes with the Last injection inetrval
timeFrame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
measure: Duration of last anti-VEGF treatment (total, per anti-VEGF agent)
timeFrame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
measure: Time since wet Age-related macular degeneration (AMD) diagnosis
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Time since any Age-related macular degeneration (AMD) diagnosis
timeFrame: 36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection)
measure: Time from last anti-VEGF injection to index date
timeFrame: 60 months prior to index ( index date defined as the date of first brolucizumab injection)
measure: Number of ocular adverse events (AEs)
timeFrame: Post-index period defined as the 180 days following therapy initiation, excluding index date
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: