NCT01273727

Ozurdex for Macular Edema Post Membrane Peeling

Ozurdex in Treatment of Macular Edema Post Membrane Peeling

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Retina Specialists, PC · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epiretinal Membrane
• Cellophane Maculopathy
• Macular Edema
• Retinal Edema

Interventions

Type	Name	Description
DRUG	Dexamethasone	intravitreal implant 0.7 mg 6 month duration
DRUG	dexamethasone	intravitreal implant 0.7 mg duration 6 months

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2011-01-10
• Last updated: 2015-05-13

Locations

1 site across 1 country: United States