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Ozurdex for Macular Edema Post Membrane Peeling

NCT01273727 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-05-13

No results posted yet for this study

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

Interventions

DRUG

Dexamethasone

intravitreal implant 0.7 mg 6 month duration

DRUG

dexamethasone

intravitreal implant 0.7 mg duration 6 months

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • Retina Specialists, PC

    lead OTHER

Principal Investigators

  • John Khadem, MD · Retina Specialists, PC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01273727 on ClinicalTrials.gov