Back to resultsOzurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery
Primary Purpose
Pseudophakic Cystoid Macular Edema,, Diabetic Macular Edema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone Implant
Sponsored by
About this trial
This is an interventional treatment trial for Pseudophakic Cystoid Macular Edema, focused on measuring pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone
Eligibility Criteria
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
Sites / Locations
- Northern California Retina Vitreous Associates
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Dexamethasone Implant
Arm Description
Patients will be treated with the Ozurdex (Dexamethasone Implant)
Outcomes
Primary Outcome Measures
BEST CORRECTED VISUAL ACUITY (ETDRS)
Secondary Outcome Measures
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY
CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME
Full Information
NCT ID
NCT01284478
First Posted
January 25, 2011
Last Updated
October 3, 2012
Sponsor
Northern California Retina Vitreous Associates
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01284478
Brief Title
Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery
Official Title
Phase 2 Study of Ozurdex for Combined Pseudophakic Cystoid Macula Edema and Diabetic Macula Edema After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Northern California Retina Vitreous Associates
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudophakic Cystoid Macular Edema,, Diabetic Macular Edema
Keywords
pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone Implant
Arm Type
Other
Arm Description
Patients will be treated with the Ozurdex (Dexamethasone Implant)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Implant
Intervention Description
Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally
Primary Outcome Measure Information:
Title
BEST CORRECTED VISUAL ACUITY (ETDRS)
Time Frame
AT DAY 180
Secondary Outcome Measure Information:
Title
RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY
Description
CENTRAL FOVEAL THICKNESS AND MACULAR VOULUME
Time Frame
90 and 180 DAYS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahul Khurana, MD
Organizational Affiliation
Northern California Retina Vitreous Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ozurdex for Combined Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema After Cataract Surgery
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