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

NCT ID: NCT05082415

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9456 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-03

Study Completion Date

2020-12-15

Brief Summary

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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.

Detailed Description

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IRIS Registry EHR data from patients with wet AMD who initiated brolucizumab were analyzed in this study.

Identification period of the index date (index period): The patients fulfilling the selection criteria was identified

* Index date: Defined as the date of the earliest brolucizumab injection
* Study Period: The period from the first patient eye exposure to brolucizumab to the last follow-up recorded
* Pre-index period: The period 36 months prior to the index date. Data within 36 months prior to the index date will be used to assess baseline characteristics.
* Post-index period: The period 180 days after the index date

Conditions

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Age-related Macular Degeneration (AMD)

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Brolucizumab

Participants received brolucizumab injection during the index period

Brolucizumab

Intervention Type DRUG

Participants received brolucizumab injection during the index period

Interventions

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Brolucizumab

Participants received brolucizumab injection during the index period

Intervention Type DRUG

Other Intervention Names

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BEOVU®

Eligibility Criteria

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Inclusion Criteria

1. ≥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)
2. ≥18 years old on the index date
3. ≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date
4. ≥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.
5. ≥1 follow-up visit after the index date
6. ≥1 VA assessment on the index date or within 90 days prior to the index date

Exclusion Criteria

1. Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
2. Unknown laterality of the index eye on the index date
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17868

Results for CRTH258AUS15 from the Novartis Clinical Trials Website

Other Identifiers

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CRTH258AUS15

Identifier Type: -

Identifier Source: org_study_id