Cellophane Maculopathy, Epiretinal Membrane, Macular Edema, Retinal Edema
Conditions
Keywords
epiretinal membrane, macular pucker, cellophane maculopathy, macular edema, retinal edema, ozurdex, dexamethasone, intravitreal implant
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.
Interventions
DRUGDexamethasone
intravitreal implant 0.7 mg 6 month duration
DRUGdexamethasone
intravitreal implant 0.7 mg duration 6 months
Sponsors
Allergan
Retina Specialists, PC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment | 6 months |
Countries
United States
Outcome results
None listed