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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06184360

Enrollment

2079

Registered

2023-12-28

Start date

2022-05-31

Completion date

2022-12-16

Last updated

2023-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular (Wet) Age-related Macular Degeneration

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

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

Countries

United States

Outcome results