Ozurdex for Macular Edema Post Membrane Peeling
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | June 2010 |
| Contact: | Cristina Rodriguez |
| Email: | rodriguez.cristina@gmail.com |
| Phone: | 212-604-9800 |
Ozurdex in Treatment of Macular Edema Post Membrane Peeling
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.
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.
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