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

Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01284478

Enrollment

Registered

2011-01-27

Start date

2011-01-31

Completion date

2012-10-31

Last updated

2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema, Pseudophakic Cystoid Macular Edema,

Keywords

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

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

Interventions

DRUGDexamethasone Implant

Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
BEST CORRECTED VISUAL ACUITY (ETDRS)	AT DAY 180

Secondary

Measure	Time frame	Description
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY	90 and 180 DAYS	CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026