Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)

NCT05082415 | Completed

• 1 other identifier: CRTH258AUS15
• Study Type: observational
• Target: 9,456
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the IRIS Registry.

Conditions

Age-related Macular Degeneration (AMD)

Keywords

Brolucizumab,; intravitreal injection,; neovascular age-related macular degeneration,; visual acuity

Outcome Measures

Primary Outcomes (1)

• Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months

  To assess IOI events observed after starting treatment with brolucizumab

  Up to 6 months post brolucizumab injection

Secondary Outcomes (24)

• Age

  At the brolucizumab index date defined as the date of first brolucizumab injection

• Gender information

  At the brolucizumab index date defined as the date of first brolucizumab injection

• Number of patients at various Patient Region

  At the brolucizumab index date defined as the date of first brolucizumab injection

• Number of patients with Insurance type

  At the brolucizumab index date defined as the date of first brolucizumab injection

• Number of patients with Laterality of wet Age-related macular degeneration (AMD)

  At the brolucizumab index date defined as the date of first brolucizumab injection

Study Arms (1)

Brolucizumab

Participants received brolucizumab injection during the index period

Drug: Brolucizumab

Interventions

Brolucizumab DRUG

Participants received brolucizumab injection during the index period

Also known as: BEOVU®

Brolucizumab

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with wet AMD who initiated brolucizumab were analyzed in this study.

You may qualify if:

• ≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or EMR note for treatment with brolucizumab during the index period (date of earliest code or EMR note = index date)
• ≥18 years old on the index date
• ≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date
• ≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in the 36 months prior to or on the index date
• o Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US.
• ≥1 follow-up visit after the index date
• ≥1 VA assessment on the index date or within 90 days prior to the index date

You may not qualify if:

• Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
• Unknown laterality of the index eye on the index date

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CRTH258AUS15 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Macular Degeneration

Interventions

brolucizumab

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: October 5, 2021
• First Posted: October 19, 2021
• Study Start: June 3, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)