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

NCT ID: NCT05111743

Last Updated: 2021-12-21

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

9261 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-17

Study Completion Date

2020-12-18

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 Komodo Healthcare Map.

Detailed Description

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Komodo Healthcare Map claims data from 08-Oct-2016 to the date of most recent 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 were identified during the period from 08-Oct-2019 to 30-Apr-2020.
* Index date: Defined as the date of the earliest brolucizumab injection during the index period.
* Study Period: The period from 08-Oct-2016 to the most recent data extraction date (05-Jun-2020).

o Note since 05-Jun-2020 was the date data was pulled, claims data from recent months (e.g. May) may be incomplete (relative to the final DB state) as well.
* Pre-index period: The period 36 months prior to the index date

o Note: Data within 36 months prior to the index date will be used to assess baseline characteristics.
* Post-index period: The period of 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

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 National Drug Code (NDC) for treatment with brolucizumab during the index period (date of earliest code = index date)
2. ≥18 years old on the index date
3. ≥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

* Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US
4. ≥24 months of continuous enrollment prior to the index date
5. ≥1 follow-up visit related to their wet AMD after the index date

Exclusion Criteria

1. Use of brolucizumab prior to 08-Oct-2019 (e.g. clinical trials)
2. Unknown laterality of the index eye on the index date
3. Patients with no data throughout the 12 months immediately prior to 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 Investigative Site

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=17875

Results for CRTH258AUS21 from the Novartis Clinical Trials Website

Other Identifiers

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CRTH258AUS21

Identifier Type: -

Identifier Source: org_study_id