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

Phase 2

Completed

• Conditions: Pseudophakic Cystoid Macular Edema,; Diabetic Macular Edema
• Interventions: Drug: Dexamethasone Implant

• Registration Number: NCT01284478
• Lead Sponsor: Northern California Retina Vitreous Associates

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-27
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexamethasone Implant	Dexamethasone Implant	Patients will be treated with the Ozurdex (Dexamethasone Implant)

Primary Outcome Measures

Name	Time	Method
BEST CORRECTED VISUAL ACUITY (ETDRS)	AT DAY 180

Secondary Outcome Measures

Name	Time	Method
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY	90 and 180 DAYS	CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME

Trial Locations

Locations (1)

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States