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

NCT ID: NCT06184360

Last Updated: 2023-12-28

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

2079 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2022-12-16

Brief Summary

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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).

Detailed Description

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Conditions

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Neovascular (Wet) Age-related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Treatment-Experienced

No interventions assigned to this group

Treatment-Naive

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 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

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CRTH258A2014

Identifier Type: -

Identifier Source: org_study_id