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Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery

NCT ID: NCT01284478

Last Updated: 2012-10-04

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery

Detailed Description

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Conditions

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Pseudophakic Cystoid Macular Edema, Diabetic Macular Edema

Keywords

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pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone

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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Dexamethasone Implant

Patients will be treated with the Ozurdex (Dexamethasone Implant)

Group Type OTHER

Dexamethasone Implant

Intervention Type DRUG

Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally

Interventions

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Dexamethasone Implant

Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
* VISUAL ACUITY WORSE THAN 20/32

Exclusion Criteria

* VISUAL ACUITY WORSE THAN 20/200
* MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING \>2 TOPICAL GLAUCOMA MEDIATIONS.
* USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Northern California Retina Vitreous Associates

OTHER

Sponsor Role lead

Responsible Party

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NORTHERN CALIFORNIA RETINA VITREOUS ASSOCIATES

Principal Investigators

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Rahul Khurana, MD

Role: PRINCIPAL_INVESTIGATOR

Northern California Retina Vitreous Associates

Locations

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Northern California Retina Vitreous Associates

Mountain View, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCRVA-2011-Ozurdex-16-1

Identifier Type: -

Identifier Source: org_study_id