A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema

NCT ID: NCT01805323

Last Updated: 2019-04-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-01

Study Completion Date

2013-04-15

Brief Summary

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This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice.

Detailed Description

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Conditions

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Macular Edema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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All Participants

Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.

Dexamethasone Intravitreal Implant

Intervention Type DRUG

Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.

Interventions

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Dexamethasone Intravitreal Implant

Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.

Intervention Type DRUG

Other Intervention Names

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OZURDEX®

Eligibility Criteria

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Inclusion Criteria

* Retinal disease involving macular edema
* Received at least one OZURDEX® injection

Exclusion Criteria

* None
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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Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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Lam WC, Albiani DA, Yoganathan P, Chen JC, Kherani A, Maberley DA, Oliver A, Rabinovitch T, Sheidow TG, Tourville E, Wittenberg LA, Sigouin C, Baptiste DC. Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study. Clin Ophthalmol. 2015 Jul 10;9:1255-68. doi: 10.2147/OPTH.S80500. eCollection 2015.

Reference Type BACKGROUND
PMID: 26203215 (View on PubMed)

Other Identifiers

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CMA-OZU-12-001

Identifier Type: -

Identifier Source: org_study_id

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