A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)

NCT ID: NCT01571557

Last Updated: 2019-04-19

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

573 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-06-30

Brief Summary

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This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.

Detailed Description

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Conditions

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Macular Edema Retinal Vein Occlusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OZURDEX®

OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.

dexamethasone 700 ug intravitreal implant

Intervention Type DRUG

dexamethasone 700 ug intravitreal implant administered according to standard of care.

Interventions

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dexamethasone 700 ug intravitreal implant

dexamethasone 700 ug intravitreal implant administered according to standard of care.

Intervention Type DRUG

Other Intervention Names

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OZURDEX®

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of macular edema following retinal vein occlusion
* Prescribed OZURDEX®

Exclusion Criteria

* Previous treatment with OZURDEX®
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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Berlin, , Germany

Site Status

Countries

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Germany

References

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Augustin AJ, Holz FG, Haritoglou C, Mayer WJ, Bopp S, Scheuerle AF, Maier M, Sekundo W, Sandner D, Shirlaw A, Hattenbach LO. Retrospective, observational study in patients receiving a dexamethasone intravitreal implant 0.7 mg for macular oedema secondary to retinal vein occlusion. Ophthalmologica. 2015;233(1):18-26. doi: 10.1159/000368840. Epub 2014 Dec 5.

Reference Type BACKGROUND
PMID: 25503473 (View on PubMed)

Other Identifiers

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MAF/AGN/OPH/RET/011

Identifier Type: -

Identifier Source: org_study_id

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