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

Novartis

Status: Completed

Conditions: Age-related Macular Degeneration (AMD)

Treatments: Drug: Brolucizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05082415

CRTH258AUS15

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 IRIS Registry.

Full description

IRIS Registry EHR 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 was identified

• Index date: Defined as the date of the earliest brolucizumab injection
• Study Period: The period from the first patient eye exposure to brolucizumab to the last follow-up recorded
• Pre-index period: The period 36 months prior to the index date. Data within 36 months prior to the index date will be used to assess baseline characteristics.
• Post-index period: The period 180 days after the index date

Enrollment: 9,456 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 EMR note for treatment with brolucizumab during the index period (date of earliest code or EMR note = index date)

2. ≥18 years old on the index date

3. ≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date

4. ≥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

   o Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US.

5. ≥1 follow-up visit after the index date

6. ≥1 VA assessment on the index date or within 90 days prior to the index date

Exclusion criteria

1. Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
2. Unknown laterality of the index eye on the index date

Trial design

9,456 participants in 1 patient group

Brolucizumab

Description:

Participants received brolucizumab injection during the index period

Treatment:

Drug: Brolucizumab