Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)

Novartis

Status: Completed

Conditions: Age-related Macular Degeneration (AMD)

Treatments: Drug: Brolucizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05111743

CRTH258AUS21

Details and patient eligibility

About

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.

Full 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

Enrollment: 9,261 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

9,261 participants in 1 patient group

Brolucizumab

Description:

Participants received brolucizumab injection during the index period

Treatment:

Drug: Brolucizumab