Ozurdex for Macular Edema Post Membrane Peeling

Sponsor

Retina Specialists, PC (Other)

Overall Status

Completed

CT.gov ID

NCT01273727

Collaborator

Allergan (Industry)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jun 1, 2010

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.