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

Completed

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

• Registration Number: NCT06184360
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-31
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-16
• Status Verified: 2023-12
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Last Update Submitted: 2023-12-14
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2079

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to adverse event	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 brolucizumab injections prior to adverse event	Baseline up to 12 months
Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status	Baseline up to 12 months
Number of eyes with adverse events	Baseline up to 12 months

Secondary Outcome Measures

Name	Time	Method
Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval	Baseline up to 12 months

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States