Ozurdex for Macular Edema Post Membrane Peeling

Ozurdex in Treatment of Macular Edema Post Membrane Peeling

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.

Study Overview

• Status: Completed
• Conditions: Macular Edema; Epiretinal Membrane; Retinal Edema; Cellophane Maculopathy
• Intervention / Treatment: Drug: Dexamethasone; Drug: dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10011
      • Retina Specialists PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: ozurdex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Retina Specialists, PC
• Collaborators: Allergan
• Investigators: Principal Investigator: John Khadem, MD, Retina Specialists, PC

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 7, 2011
• First Posted (Estimate): January 10, 2011

Study Record Updates

• Last Update Posted (Estimate): May 13, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: macular edema; dexamethasone; epiretinal membrane; macular pucker; cellophane maculopathy; retinal edema; ozurdex; intravitreal implant
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Macular Degeneration; Macular Edema; Edema; Epiretinal Membrane; Papilledema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: 3433-001