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

NCT06184360 | Completed

• 1 other identifier: CRTH258A2014
• Study Type: observational
• Target: 2,079
• Locations: 1 country
• Sites: 1

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).

Conditions

Neovascular (Wet) Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval

  Baseline up to 12 months

Study Arms (2)

Treatment-Experienced

Treatment-Naive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: May 31, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 16, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

US (1)