Ozurdex for Macular Edema Post Membrane Peeling

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
John Khadem, Retina Specialists, PC
ClinicalTrials.gov Identifier:
NCT01273727
First received: January 7, 2011
Last updated: February 27, 2013
Last verified: February 2013

January 7, 2011
February 27, 2013
June 2010
June 2013   (final data collection date for primary outcome measure)
mean best corrected visual acuity as measured by Snellen visual acuity compared to enrollment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01273727 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Ozurdex for Macular Edema Post Membrane Peeling
Ozurdex in Treatment of Macular Edema Post Membrane Peeling

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epiretinal Membrane
  • Cellophane Maculopathy
  • Macular Edema
  • Retinal Edema
  • Drug: Dexamethasone
    intravitreal implant 0.7 mg 6 month duration
    Other Name: Ozurdex
  • Drug: dexamethasone
    intravitreal implant 0.7 mg duration 6 months
    Other Name: ozurdex
  • 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
    Intervention: Drug: Dexamethasone
  • 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
    Intervention: Drug: dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
Not Provided
June 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01273727
3433-001
Yes
John Khadem, Retina Specialists, PC
Retina Specialists, PC
Allergan
Principal Investigator: John Khadem, MD Retina Specialists, PC
Retina Specialists, PC
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP