Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)

This was a retrospective, observational cohort study. Data were analyzed from the Intelligent Research in Sight (IRIS) registry from October 8, 2019, through November 26, 2021, with a follow-up period of 12 months following the first brolucizumab injection (index date).

Study Overview

• Status: Completed
• Conditions: Neovascular (Wet) Age-related Macular Degeneration

• Study Type: Observational
• Enrollment (Actual): 2079

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

Inclusion Criteria:

• At least 18 years old at the time of their first (index) injection of brolucizumab.
• Had documented neovascular age-related macular degeneration (nAMD) on or within 3 years before the index injection.
• Used only brolucizumab for at least 12 months (± 45 days) after the index injection, with at least 1 brolucizumab injection given within the first 6 months after the index injection and at least 1 additional brolucizumab injection given at 6-12 months after the index injection.

Exclusion Criteria:

• Had received any other anti-VEGF agent between the index injection and 12-month follow-up.
• Lacked information about the laterality of disease at the time of the index injection.
• Lacked visual acuity assessments on or within 30 days before the index injection or at 6, 9, and 12 months after the index injection (all of the latter ± 45 days).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Treatment-Experienced
Treatment-Naive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status	Baseline up to 12 months
Change in Injection Interval at 12 Months of Brolucizumab Treatment Compared with Prior Anti-vascular Endothelial Growth Factor (VEGF) Treatment	Baseline up to 12 months
Number of eyes with adverse events	Baseline up to 12 months
Time to adverse event	Baseline up to 12 months
Number of brolucizumab injections prior to adverse event	Baseline up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval	Baseline up to 12 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: CRTH258A2014