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OpenTrials
Completed

NCT Number: NCT01284478

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

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

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Key information

Conditions

Pseudophakic Cystoid Macular Edema, Diabetic Macular Edema Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone implant

Drug

Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally

Primary outcomes

  1. BEST CORRECTED VISUAL ACUITY (ETDRS)

    Time frame: AT DAY 180

Secondary outcomes

  1. RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY

    Time frame: 90 and 180 DAYS

    CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME

Sponsors and collaborators

Lead sponsor

Northern California Retina Vitreous Associates

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2011
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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