Clinical trial NCT01273727: Ozurdex for Macular Edema Post Membrane Peeling
Official title: Ozurdex in Treatment of Macular Edema Post Membrane Peeling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Epiretinal Membrane
Cellophane Maculopathy
Macular Edema
Retinal Edema
Keywords: epiretinal membrane
macular pucker
cellophane maculopathy
macular edema
retinal edema
ozurdex
dexamethasone
intravitreal implant
Lead sponsor: Retina Specialists, PC
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-01-10
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment
timeFrame: 6 months
Secondary outcomes:
measure: mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Retina Specialists PC
state: New York
Study officials:
affiliation: Retina Specialists, PC
name: John Khadem, MD
role: PRINCIPAL_INVESTIGATOR
References: