Ozurdex for Macular Edema Post Membrane Peeling

NCT01273727 | Completed Phase 2 DMC

• 1 other identifier: 3433-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

epiretinal membrane; macular pucker; cellophane maculopathy; macular edema; retinal edema; ozurdex; dexamethasone; intravitreal implant

Outcome Measures

Primary Outcomes (1)

• mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment

  6 months

Secondary Outcomes (1)

• mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment

  6 months

Study Arms (3)

No Ozurdex

NO INTERVENTION

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.

Ozurdex 3 months after surgery

EXPERIMENTAL

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

Ozurdex 6 months or longer after surgery

EXPERIMENTAL

Patients who have had epiretinal membrane peeling and have residual macular edema at least 6 months after surgery

Drug: dexamethasone

Interventions

dexamethasone DRUG

intravitreal implant 0.7 mg 6 month duration

Also known as: Ozurdex

Ozurdex 3 months after surgery

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Retina Specialists, PC: lead
• Allergan: collaborator

Study Sites (1)

Retina Specialists PC

New York, New York, 10011, United States

Location

MeSH Terms

Conditions

Epiretinal Membrane; Macular Edema; Papilledema

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• John Khadem, MD

  Retina Specialists, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: June 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

US (1)