NCT05082415

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9,456 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 IRIS Registry.

Detailed 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

Conditions

• Age-related Macular Degeneration (AMD)

Interventions

Type	Name	Description
DRUG	Brolucizumab	Participants received brolucizumab injection during the index period

Timeline

• Start date: 2020-06-03
• Primary completion: 2020-12-15
• Completion: 2020-12-15
• First posted: 2021-10-19
• Last updated: 2021-10-27

Locations

1 site across 1 country: United States