Chart Review: Drug Utilization Study in Participants Who Received Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)

NCT ID: NCT03889444

Last Updated: 2020-06-22

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

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-06-07

Brief Summary

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A retrospective, non-interventional, observational, multi-center, drug utilization study to be conducted in adult participants with visual impairment due to DME treated with Ozurdex implants in Germany and Switzerland from 1 January 2015 to 1 September 2017.

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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OZURDEX®

Participants with diabetic macular edema prescribed dexamethasone intravitreal implant, 0.7 mg (OZURDEX®) as per routine clinical practice.

Dexamethasone intravitreal implant

Intervention Type DRUG

Dexamethasone intravitreal implant 0.7 mg injection, as per routine clinical practice.

Interventions

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Dexamethasone intravitreal implant

Dexamethasone intravitreal implant 0.7 mg injection, as per routine clinical practice.

Intervention Type DRUG

Other Intervention Names

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OZURDEX®

Eligibility Criteria

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Inclusion Criteria

* Participant received at least two Ozurdex® implants in the study eye to treat visual impairment due to DME
* First Ozurdex® implant injection occurred after 1 January 2015
* Participant was followed-up at the site for at least 12 months after the first Ozurdex® implant in the study eye

Exclusion Criteria

\- Participant received Ozurdex® implants as part or during a clinical study
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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Paramjit Singh

Role: STUDY_DIRECTOR

Allergan

Locations

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Clinical Trials Registry Team

Irvine, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

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http://AllerganClinicalTrials.com

Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance.

Other Identifiers

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CMO-MA-EYE-0564

Identifier Type: -

Identifier Source: org_study_id

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