Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)

NCT ID: NCT01411696

Last Updated: 2013-04-16

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

289 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-03-31

Brief Summary

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This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.

Detailed Description

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Conditions

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Retinal Vein Occlusion Macular Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All Participants

Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.

dexamethasone intravitreal implant 0.7 mg

Intervention Type DRUG

Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.

Interventions

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dexamethasone intravitreal implant 0.7 mg

Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.

Intervention Type DRUG

Other Intervention Names

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OZURDEX®

Eligibility Criteria

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Inclusion Criteria

* Macular edema
* Received at least 2 OZURDEX® injections

Exclusion Criteria

* Received OZURDEX® injections as part of 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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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Dugel PU, Capone A Jr, Singer MA, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants in treatment-naive patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Sep 4;15:118. doi: 10.1186/s12886-015-0106-z.

Reference Type DERIVED
PMID: 26337664 (View on PubMed)

Singer MA, Capone A Jr, Dugel PU, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Apr 1;15:33. doi: 10.1186/s12886-015-0018-y.

Reference Type DERIVED
PMID: 25885285 (View on PubMed)

Other Identifiers

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GMA-320

Identifier Type: OTHER

Identifier Source: secondary_id

GMA-OZU-09-011

Identifier Type: -

Identifier Source: org_study_id

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