Back to resultsOzurdex for Macular Edema Post Membrane Peeling
Primary Purpose
Epiretinal Membrane, Cellophane Maculopathy, Macular Edema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Membrane focused on measuring epiretinal membrane, macular pucker, cellophane maculopathy, macular edema, retinal edema, ozurdex, dexamethasone, intravitreal implant
Eligibility Criteria
Inclusion Criteria
- Patients with macular edema who have had previous epi-retinal membrane peeling surgery for macular edema associated with epi-retinal membranes.
- All patients must have clear ocular media/lenses determined visually by the investigator in order to permit good quality stereoscopic fundus photography, fluorescein angiography and ocular coherence tomography.
Exclusion Criteria:
- Best corrected visual acuity 20/50 or better in the study eye
- Sub-macular hemorrhage in the study eye
- Sub-retinal fibrosis in the study eye
- Macular hole in the study eye
- Active inflammatory disease of the study eye
- Choroidal neovascularization in the study eye
- History of other ophthalmic disorders with the exception of cataract or previous cataract extraction in the study eye
- Active ocular infection in the study eye
- Previous subfoveal laser treatment in the study eye
- Previous verteporfin photodynamic therapy in the study eye
- Any systemic medical condition that would preclude them from undergoing surgery with monitored sedation.
Sites / Locations
- Retina Specialists PC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
No Ozurdex
Ozurdex 3 months after surgery
Ozurdex 6 months or longer after surgery
Arm Description
Arm 1(control) - Patients who have had epi-retinal membrane peeling and have macular edema at least 3 months (90 days) after surgery. These patients will followed without Ozurdex. The patients will be treated with current standard of care, including topical and intravitreal or subtenon's medication.
Patients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant
Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery
Outcomes
Primary Outcome Measures
mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment
Secondary Outcome Measures
mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment
Full Information
NCT ID
NCT01273727
First Posted
January 7, 2011
Last Updated
May 12, 2015
Sponsor
Retina Specialists, PC
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01273727
Brief Title
Ozurdex for Macular Edema Post Membrane Peeling
Official Title
Ozurdex in Treatment of Macular Edema Post Membrane Peeling
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Retina Specialists, PC
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of vision and lead to swelling, or macular edema. Despite surgery to remove the scar tissue(membrane peeling), residual swelling of the retina may continue to interfere with vision.
In this study the investigators will inject an implantable steroid device into the back, fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration (FDA) for decreasing swelling due to another condition in the eye. This study will help to find out whether or not this device Ozurdex™ is also effective for reducing the swelling of the retina in patients who have already had surgery to remove scar tissue on the retina.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane, Cellophane Maculopathy, Macular Edema, Retinal Edema
Keywords
epiretinal membrane, macular pucker, cellophane maculopathy, macular edema, retinal edema, ozurdex, dexamethasone, intravitreal implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Ozurdex
Arm Type
No Intervention
Arm Description
Arm 1(control) - Patients who have had epi-retinal membrane peeling and have macular edema at least 3 months (90 days) after surgery. These patients will followed without Ozurdex. The patients will be treated with current standard of care, including topical and intravitreal or subtenon's medication.
Arm Title
Ozurdex 3 months after surgery
Arm Type
Experimental
Arm Description
Patients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant
Arm Title
Ozurdex 6 months or longer after surgery
Arm Type
Experimental
Arm Description
Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Ozurdex
Intervention Description
intravitreal implant 0.7 mg 6 month duration
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
ozurdex
Intervention Description
intravitreal implant 0.7 mg duration 6 months
Primary Outcome Measure Information:
Title
mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients with macular edema who have had previous epi-retinal membrane peeling surgery for macular edema associated with epi-retinal membranes.
All patients must have clear ocular media/lenses determined visually by the investigator in order to permit good quality stereoscopic fundus photography, fluorescein angiography and ocular coherence tomography.
Exclusion Criteria:
Best corrected visual acuity 20/50 or better in the study eye
Sub-macular hemorrhage in the study eye
Sub-retinal fibrosis in the study eye
Macular hole in the study eye
Active inflammatory disease of the study eye
Choroidal neovascularization in the study eye
History of other ophthalmic disorders with the exception of cataract or previous cataract extraction in the study eye
Active ocular infection in the study eye
Previous subfoveal laser treatment in the study eye
Previous verteporfin photodynamic therapy in the study eye
Any systemic medical condition that would preclude them from undergoing surgery with monitored sedation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Khadem, MD
Organizational Affiliation
Retina Specialists, PC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Specialists PC
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
12. IPD Sharing Statement
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Ozurdex for Macular Edema Post Membrane Peeling
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