Ozurdex for Macular Edema Post Membrane Peeling

This study has been completed.
Information provided by (Responsible Party):
John Khadem, Retina Specialists, PC
ClinicalTrials.gov Identifier:
First received: January 7, 2011
Last updated: May 12, 2015
Last verified: May 2015

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 Intervention Phase
Epiretinal Membrane
Cellophane Maculopathy
Macular Edema
Retinal Edema
Drug: Dexamethasone
Drug: dexamethasone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ozurdex in Treatment of Macular Edema Post Membrane Peeling

Resource links provided by NLM:

Further study details as provided by Retina Specialists, PC:

Primary Outcome Measures:
  • mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01273727

United States, New York
Retina Specialists PC
New York, New York, United States, 10011
Sponsors and Collaborators
Retina Specialists, PC
Principal Investigator: John Khadem, MD Retina Specialists, PC
  More Information

Responsible Party: John Khadem, Principal Investigator, Retina Specialists, PC
ClinicalTrials.gov Identifier: NCT01273727     History of Changes
Other Study ID Numbers: 3433-001 
Study First Received: January 7, 2011
Last Updated: May 12, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Retina Specialists, PC:
epiretinal membrane
macular pucker
cellophane maculopathy
macular edema
retinal edema
intravitreal implant

Additional relevant MeSH terms:
Epiretinal Membrane
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016