Ozurdex in Treatment of Macular Edema Post Membrane Peeling
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Arms & Interventions
Ozurdex 3 months after surgery
Patients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant
Intervention: dexamethasone (Drug)
Ozurdex 6 months or longer after surgery
Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery
Intervention: dexamethasone (Drug)
Outcomes
Primary Outcomes
mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment
Time Frame: 6 months
Secondary Outcomes
- mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment(6 months)
Investigators
John Khadem
Principal Investigator
Retina Specialists, PC