Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea

NCT ID: NCT01976650

Last Updated: 2016-01-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

724 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-03-31

Brief Summary

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This study is a Post-Market Surveillance study in Korea to evaluate the safety and efficacy of dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant used to treat Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye in clinical practice.

Detailed Description

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Conditions

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Retinal Vein Occlusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OZURDEX®

Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.

dexamethasone 700 ㎍ intravitreal implant

Intervention Type DRUG

dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.

Interventions

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dexamethasone 700 ㎍ intravitreal implant

dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.

Intervention Type DRUG

Other Intervention Names

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OZURDEX®

Eligibility Criteria

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Inclusion Criteria

* Patients with Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye treated with (OZURDEX®) in clinical practice.

Exclusion Criteria

* Patients with eye infections
* Patients with glaucoma.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim MS, Choi J, Lee HD, Woo SJ; Korea Ozurdex Post-Marketing Surveillance Study Group. Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea. Clin Ophthalmol. 2021 Aug 27;15:3623-3636. doi: 10.2147/OPTH.S302014. eCollection 2021.

Reference Type DERIVED
PMID: 34475750 (View on PubMed)

Other Identifiers

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206207-029

Identifier Type: -

Identifier Source: org_study_id

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