Ozurdex for Macular Edema Post Membrane Peeling

Phase 2

Completed

• Conditions: Cellophane Maculopathy; Macular Edema; Retinal Edema; Epiretinal Membrane
• Interventions: Drug: dexamethasone

• Registration Number: NCT01273727
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ozurdex 6 months or longer after surgery	dexamethasone	Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery
Ozurdex 3 months after surgery	dexamethasone	Patients who have had epi-retinal membrane peeling and have residual macular edema 3 months after surgery. These patients will receive an Ozurdex implant

Primary Outcome Measures

Name	Time	Method
mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Retina Specialists PC; 🇺🇸 New York, New York, United States