Ozurdex for Macular Edema Post Membrane Peeling

Macular Edema Clinical Trial

Official title:

Ozurdex in Treatment of Macular Edema Post Membrane Peeling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273727
• Other study ID #: 3433-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 7, 2011
• Last updated: May 12, 2015
• Start date: June 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: Retina Specialists, PC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cellophane Maculopathy
• Edema
• Epiretinal Membrane
• Macular Edema
• Retinal Edema

Intervention

Drug:
• Dexamethasone
intravitreal implant 0.7 mg 6 month duration
• dexamethasone
intravitreal implant 0.7 mg duration 6 months

Locations

Country	Name	City	State
United States	Retina Specialists PC	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Retina Specialists, PC	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment		6 months	Yes
Secondary	mean decrease in area and or volume of central foveal thickness as measured by OCT compared to enrollment		6 months	No