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Completed

NCT Number: NCT01273727

Ozurdex for 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.

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Key information

Conditions

Epiretinal Membrane Cellophane Maculopathy Cranial Nerve Diseases Eye Diseases Macular Degeneration Macular Edema Nervous System Diseases Optic Nerve Diseases Papilledema Retinal Degeneration Retinal Diseases Retinal Edema

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Retina Specialists PC

New York, 10011, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

intravitreal implant 0.7 mg 6 month duration

Other names: Ozurdex

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Retina Specialists, PC

Other

Collaborators

  • Allergan

Registry information

Official study title

Ozurdex in Treatment of Macular Edema Post Membrane Peeling

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 10, 2011
Registry last updated
May 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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