Ozurdex for Macular Edema Post Membrane Peeling

Overview

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.

Full Title of Study: “Ozurdex in Treatment of Macular Edema Post Membrane Peeling”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2014

Interventions

  • Drug: Dexamethasone
    • intravitreal implant 0.7 mg 6 month duration
  • Drug: dexamethasone
    • intravitreal implant 0.7 mg duration 6 months

Arms, Groups and Cohorts

  • No Intervention: No Ozurdex
    • Arm 1(control) – Patients who have had epi-retinal membrane peeling and have macular edema at least 3 months (90 days) after surgery. These patients will followed without Ozurdex. The patients will be treated with current standard of care, including topical and intravitreal or subtenon’s medication.
  • Experimental: Ozurdex 3 months after surgery
    • Patients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant
  • Experimental: Ozurdex 6 months or longer after surgery
    • Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery

Clinical Trial Outcome Measures

Primary Measures

  • mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment
    • Time Frame: 6 months

Secondary Measures

  • mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Retina Specialists, PC
  • Collaborator
    • Allergan
  • Provider of Information About this Clinical Study
    • Principal Investigator: John Khadem, Principal Investigator – Retina Specialists, PC
  • Overall Official(s)
    • John Khadem, MD, Principal Investigator, Retina Specialists, PC

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