Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab

Treatment History, Demographic Characteristics, Clinical Characteristics, and Early Treatment Patterns of Patients Who Received Brolucizumab for Neovascular Age-related Macular Degeneration: IRIS Registry Study

This was a retrospective cohort study to assess the treatment history, demographic characteristics, clinical characteristics, and early treatment patterns of patients who received brolucizumab for neovascular age-related macular degeneration using IRIS Registry.

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration (AMD)
• Intervention / Treatment: Drug: Brolucizumab

Detailed Description

This was a retrospective cohort study of patients with wet AMD who received brolucizumab. Evidence was generated from the IRIS registry to describe patient treatment histories, demographic and clinical characteristics, and early treatment patterns.

Setting and study population:

IRIS Registry EHR data from 10/08/2018 to the 03/31/2020 from patients with wet AMD who initiated brolucizumab were analyzed.

Identification period of the index date: The patients fulfilling the selection criteria identified during the period from 10/08/2019 to 03/31/2020.

Index date: Defined as the date of the earliest brolucizumab injection.

Study Period: The period from 10/08/2018 to 03/31/2020.

Pre-index period: The period 12 months prior to the index date.

Post-index period: The period 4 months after the index date (not a required selection criterion; only for the assessment of select endpoints in a subgroup of patients).

• Study Type: Observational
• Enrollment (Actual): 9457

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936-1080
      • Novartis Investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Patients with ≥1 brolucizumab injection
• Diagnosis of wet AMD (ICD-10: H35.3210, H35.3211, H35.3212, H35.3213, H35.3220, H35.3221, H35.3222, H35.3223, H35.3230, H35.3231, H35.3232, H35.3233, H35.3290, H35.3291, H35.3292, and H35.3293) on the index date

Exclusion Criteria:

• There were no exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brolucizumab; Participants received brolucizumab injection during the index period	Drug: Brolucizumab; Participants received brolucizumab injection during the index period; Other Names: BEOVU®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months	To describe anti-VEGF treatment status (naive or switcher) in patients with wet AMD who initiated brolucizumab	Up to 4 months post brolucizumab injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age information	Age information was reported	Index date
Gender information	Gender information was reported	Index date
Number of participants: Regions	Northeast, North Central, South, West, Unknown	12-month period prior to index
Number of participants: Insurance type	Private, Medicare, Medicare Advantage, Medicaid, Other	12-month period prior to index
Number of participants: Laterality	Unilateral, Bilateral	12-month period prior to index
Number of participants: Race	White, African American, Asian	12-month period prior to index
Number of participants: Concurrent eye disease	Participants were measured at the eye level for the following eye diseases: Cataracts, Posterior vitreous detachment, Epiretinal membrane, Macular hole, Vitreomacular traction, Amblyopia, Pseudophakia, Glaucoma, Diabetic macular edema, Retinal vein occlusion, Diabetic retinopathy, Myopic choroidal neovascularization	12-month period prior to index
Number of participants: Provider specialty	Participants were categorized based on provider specialty at date of first brolucizumab injection (e.g. Retina specialist, Ophthalmologist, etc)	At the brolucizumab index date defined as the date of first brolucizumab injection
Encounter location (practice location)	Midwest, Northeast, South, West, Unknown	At the brolucizumab index date defined as the date of first brolucizumab injection
Eye location of brolucizumab injections	e.g. OD [eye, right], OS [eye, left], Unspecified	12-month period prior to index
Index Visual acuity (VA)	Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters). Snellen VA ranges: 20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse	At the brolucizumab index date defined as the date of first brolucizumab injection
Wet AMD diagnosis for the fellow eye	Wet AMD diagnosis for the fellow eye as of the index date (Yes/No)	At the brolucizumab index date defined as the date of first brolucizumab injection
Visual acuity of the fellow eye	Visual acuity using Snellen and approximate Early Treatment Diabetic Retinopathy Study [ETDRS] letters). Snellen VA ranges: 20/12-20/20 20/25-20/40 20/50-20/160 20/200 or worse	At the brolucizumab index date defined as the date of first brolucizumab injection
Number of prior anti-VEGF treatments	Number of anti-VEGF treatments used prior to brolucizumab at index by number of eyes were reported	12-month period prior to index
Type of prior anti-VEGF treatment among switchers to brolucizumab	Type of anti-VEGF agent (aflibercept, bevacizumab, ranibizumab, unlicensed bevacizumab) used immediately prior to index were reported	12-month period prior to index
Prior anti-VEGF treatment sequence	Prior treatment sequence(s) for previously treated eyes were reported. Continuous or Categorical (aflibercept, bevacizumab and ranibizumab)	12-month period prior to index
Number of prior anti-VEGF injections received prior to brolucizumab index date	Total and Per treatment prior anti-VEGF injections received prior to brolucizumab index date were reported	12-month period prior to index
Injection intervals for the eyes that had received anti-VEGF injections prior to index	Last injection interval, Average of last two injection intervals and Average of last three injection intervals were reported	12-month period prior to index
Anti-VEGF treatment status for the fellow eye	Anti-VEGF treatment endpoints for the fellow eyes with wet AMD (Naive, Switcher) were reported	At the brolucizumab index date defined as the date of first brolucizumab injection
Type of treatment for the fellow eye	Following type of treatment for the fellow eye will be reported: aflibercept, bevacizumab, ranibizumab, brolucizumab, unlicensed bevacizumab, or none)	At the brolucizumab index date defined as the date of first brolucizumab injection
The number of prior anti-VEGF treatments for the fellow eye	Number of prior anti-VEGF injections for the fellow eye will be reported: Continuous or Categorical (e.g. 0, 1, ≥2)	At the brolucizumab index date defined as the date of first brolucizumab injection
Number of brolucizumab injections received per study eye	Early treatment patterns after brolucizumab index date in anti-VEGF switcher and anti-VEGF naive patient eyes were reported	Up to 4 months post index date
The last injection interval	The length of the interval between the final two injections was reported	Up to 4 months post index date
The first injection interval after switch compared to last injection interval with a prior treatment	Longer, same or shorter interval were reported	Up to 4 months post index date
Type of anti-VEGF agent initiated after switching from index brolucizumab	Thr type of anti-VEGF agent initiated in the first 3 months after switching from index brolucizumab. were reported	First 3 months after switching from index brolucizumab

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CRTH258AUS12 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2020
• Primary Completion (ACTUAL): August 1, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (ACTUAL): September 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: treatment-naive; AMD,; brolucizumab,; anti-VEGF switchers,
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: CRTH258AUS12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No