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Ozurdex for Macular Edema Post Membrane Peeling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01273727
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
John Khadem, Retina Specialists, PC

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.

Condition or disease Intervention/treatment Phase
Epiretinal Membrane Cellophane Maculopathy Macular Edema Retinal Edema Drug: Dexamethasone Drug: dexamethasone Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ozurdex in Treatment of Macular Edema Post Membrane Peeling
Study Start Date : June 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
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
Drug: Dexamethasone
intravitreal implant 0.7 mg 6 month duration
Other Name: Ozurdex

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
Drug: dexamethasone
intravitreal implant 0.7 mg duration 6 months
Other Name: ozurdex

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01273727

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United States, New York
Retina Specialists PC
New York, New York, United States, 10011
Sponsors and Collaborators
Retina Specialists, PC
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Principal Investigator: John Khadem, MD Retina Specialists, PC
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Responsible Party: John Khadem, Principal Investigator, Retina Specialists, PC Identifier: NCT01273727    
Other Study ID Numbers: 3433-001
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by John Khadem, Retina Specialists, PC:
epiretinal membrane
macular pucker
cellophane maculopathy
macular edema
retinal edema
intravitreal implant
Additional relevant MeSH terms:
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Macular Edema
Epiretinal Membrane
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action