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Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

NCT ID: NCT01946399

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-09-01

Brief Summary

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To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.

Detailed Description

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To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.

Conditions

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Retinal Vein Occlusion (RVO) Macular Edema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ozurdex implant

Intravitreal injection of Ozurdex implant

Group Type OTHER

Ozurdex implant

Intervention Type DRUG

Intravitreal injection of Dexamethasone implant

Interventions

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Ozurdex implant

Intravitreal injection of Dexamethasone implant

Intervention Type DRUG

Other Intervention Names

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Dexamethasone implant

Eligibility Criteria

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Inclusion Criteria

All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months.

Exclusion Criteria

* Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes
* Interval surgical intervention, such as cataract surgery, that may confound visual outcomes.
* Pregnancy
* Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including:
* Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases)
* Advanced glaucoma
* Aphakic eyes with rupture or missing posterior lens capsule
* Eyes with anterior chamber intraocular lens and missing posterior lens capsule
* Patients with known hypersensitivity to components of this product
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Retina-Vitreous Associates Medical Group

OTHER

Sponsor Role collaborator

West Coast Retina Medical Group, Inc.

OTHER

Sponsor Role collaborator

Retina Research Institute, LLC

OTHER

Sponsor Role lead

Responsible Party

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Rhonda Weeks

Gaurav K. Shah, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaurav K Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Research Institute

Locations

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The Retina Institute

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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Ozurdex RVO 2013

Identifier Type: -

Identifier Source: org_study_id