Skip to main content
OpenTrials
Completed

NCT Number: NCT06184360

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neovascular (Wet) Age-related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status

    Time frame: Baseline up to 12 months

  2. Change in Injection Interval at 12 Months of Brolucizumab Treatment Compared with Prior Anti-vascular Endothelial Growth Factor (VEGF) Treatment

    Time frame: Baseline up to 12 months

  3. Number of eyes with adverse events

    Time frame: Baseline up to 12 months

  4. Time to adverse event

    Time frame: Baseline up to 12 months

  5. Number of brolucizumab injections prior to adverse event

    Time frame: Baseline up to 12 months

Secondary outcomes

  1. Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval

    Time frame: Baseline up to 12 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2023
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.