Ozurdex for Macular Edema Post Membrane Peeling

NCT ID: NCT01273727

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-04-30

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.

Conditions

Epiretinal Membrane; Cellophane Maculopathy; Macular Edema; Retinal Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

intravitreal implant 0.7 mg 6 month duration

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

Group Type: EXPERIMENTAL

dexamethasone

Intervention Type: DRUG

intravitreal implant 0.7 mg duration 6 months

Interventions

Dexamethasone

intravitreal implant 0.7 mg 6 month duration

Intervention Type: DRUG

dexamethasone

intravitreal implant 0.7 mg duration 6 months

Intervention Type: DRUG

Other Intervention Names

Ozurdex; ozurdex

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Retina Specialists, PC

OTHER

Sponsor Role: lead

Responsible Party

John Khadem

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Khadem, MD

Role: PRINCIPAL_INVESTIGATOR

Retina Specialists, PC

Locations

Retina Specialists PC

New York, New York, United States

Countries

United States

Other Identifiers

3433-001

Identifier Type: -

Identifier Source: org_study_id