Ozurdex for Macular Edema Post Membrane Peeling - Full Text View

Purpose

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone sodium phosphate

U.S. FDA Resources

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 ]

Estimated Enrollment:	36
Study Start Date:	June 2010
Estimated Primary Completion Date:	June 2013 (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

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273727

Locations

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

Sponsors and Collaborators

Retina Specialists, PC

Allergan

Investigators

Principal Investigator:

John Khadem, MD

Retina Specialists, PC

More Information

No publications provided

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:	February 27, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Retina Specialists, PC:

epiretinal membrane
macular pucker
cellophane maculopathy
macular edema

retinal edema
ozurdex
dexamethasone
intravitreal implant

Additional relevant MeSH terms:

Edema
Macular Edema
Retinal Diseases
Papilledema
Epiretinal Membrane
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate

BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013