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

Neovascular (Wet) Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06184360
• Other study ID #: CRTH258A2014
• Status: Completed
• Start date: May 31, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: December 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2079
• Est. completion date: December 16, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Novartis	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status		Baseline up to 12 months
Primary	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
Primary	Number of eyes with adverse events		Baseline up to 12 months
Primary	Time to adverse event		Baseline up to 12 months
Primary	Number of brolucizumab injections prior to adverse event		Baseline up to 12 months
Secondary	Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval		Baseline up to 12 months