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Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up

NCT ID: NCT06178770

Last Updated: 2023-12-21

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

414 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-12-12

Brief Summary

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This retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-vascular endothelial growth factor (VEGF) and had ≥3 brolucizumab injections with no other anti-VEGF in the first 12 months (360 days) and 18 months (540 days) of follow-up respectively; and the 12-month and 18-month alternating (ALT) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-VEGF to brolucizumab and had ≥2 brolucizumab injections and ≥1 injection of another anti-VEGF in the first 12 months and 18 months of follow-up, respectively.

Detailed Description

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Conditions

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Neovascular Age-related Macular Degeneration

Keywords

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nAMD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Overall cohort

No interventions assigned to this group

12-month BRO cohort

No interventions assigned to this group

18-month BRO cohort

No interventions assigned to this group

12-month ALT cohort

No interventions assigned to this group

18-month ALT cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of nAMD.
* Patients were on a previous anti-VEGF therapy and then switched to brolucizumab.
* Patients remained on brolucizumab for at least 12 months.
* Patients had exactly 360 days or more of follow-up after first brolucizumab injection.
* For BRO cohort only: Patients received at least three injections of brolucizumab during study period.
* For ALT cohort only: Patients received at least two injections of brolucizumab and one injection of another anti-VEGF during the study period.

Exclusion Criteria

* For BRO cohort only: Patients who received any other anti-VEGF therapy during the 12-month follow-up period.
* Eyes missing bilaterality information in their nAMD diagnosis.
* Eyes missing bilaterality information in their brolucizumab injections.
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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CRTH258A2018

Identifier Type: -

Identifier Source: org_study_id