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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Northern California Retina Vitreous Associates
ClinicalTrials.gov Identifier:
NCT01284478
First received: January 25, 2011
Last updated: October 3, 2012
Last verified: October 2012

January 25, 2011
October 3, 2012
January 2011
October 2012   (final data collection date for primary outcome measure)
BEST CORRECTED VISUAL ACUITY (ETDRS) [ Time Frame: AT DAY 180 ] [ Designated as safety issue: Yes ]
BEST CORRECTED VISUAL ACUITY (ETDRS) [ Time Frame: AT DAY 90 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01284478 on ClinicalTrials.gov Archive Site
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY [ Time Frame: 90 and 180 DAYS ] [ Designated as safety issue: Yes ]
CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY [ Time Frame: 90 DAYS ] [ Designated as safety issue: Yes ]
CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pseudophakic Cystoid Macular Edema,
  • Diabetic Macular Edema
Drug: Dexamethasone Implant
Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally
Dexamethasone Implant
Patients will be treated with the Ozurdex (Dexamethasone Implant)
Intervention: Drug: Dexamethasone Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01284478
NCRVA-2011-Ozurdex-16-1
No
RAHUL KHURANA, M.D. / PRINCIPAL INVESTIGATOR, NORTHERN CALIFORNIA RETINA VITREOUS ASSOCIATES
Northern California Retina Vitreous Associates
Allergan
Principal Investigator: Rahul Khurana, MD Northern California Retina Vitreous Associates
Northern California Retina Vitreous Associates
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP