Clinical Trial: Ozurdex for Macular Edema Post Membrane Peeling

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ozurdex in Treatment of Macular Edema Post Membrane Peeling

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.

Detailed Summary:
Sponsor: Retina Specialists, PC

Current Primary Outcome: mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: Retina Specialists, PC

Dates:
Date Received: January 7, 2011
Date Started: June 2010
Date Completion:
Last Updated: May 12, 2015
Last Verified: May 2015