A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes

January 4, 2016 updated by: Sunnybrook Health Sciences Centre

A Prospective Multicentre Pilot Study of the Effectiveness of an Intra-operative Intravitreal Sustained Release Dexamethasone Implant (Ozurdex®) in Vitrectomy Surgery for Epiretinal Membranes

To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in retinal thickness and volume.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We believe that the use of intravitreal corticosteroids post-operatively has the capacity to mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy for epiretinal membranes. The unique pharmacokinetics of the sustained released dexamethasone implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal membrane surgery. Its duration of action and its drug delivery characteristics over 6 months approximately match the post-operative time course of healing and remodeling in an edematous retina.

This is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in 15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • SunnyBrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Peter J Kertes, MD,CM,FRCSC
      • Toronto, Ontario, Canada, M5C 2T2
        • Recruiting
        • St. Michael's Hospital
        • Contact:
        • Principal Investigator:
          • Rajeev Muni, MD,FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic epiretinal membrane.
  • Central retinal thickness ≥ 250 μm.
  • Age more than 18 years old.
  • Decision makers able to give informed consent.
  • Females of child bearing potential must agree to use acceptable means of birth control for the duration of the study.

Exclusion Criteria:

  • Secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.).
  • Any other macular pathology that could affect anatomic or functional results.
  • History of uveitis requiring intravitreal triamcinolone injection.
  • History of steroid-responsive glaucoma.
  • History of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7).
  • IOP > 23 mm Hg if untreated, or > 21 mm Hg if treated with medication.
  • Pregnant or breast-feeding woman.
  • Unable to attend the scheduled follow-up appointments.
  • Patients with known hypersensitivity to any components of Ozurdex® or to other corticosteroids.
  • Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ozurdex
Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane
Drug: Ozurdex
biodegradable 0.7mg dexamethasone implant
Other Names:
  • 0.7mg dexamethasone implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity
Time Frame: 3 Months
Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity at 1,4 and 6 months
Time Frame: 6 months
Best corrected visual acuity measured at 1,4 and 6 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
6 months
Retinal thickness and volume
Time Frame: 6 months
Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).
6 months
Intraocular pressure (IOP)
Time Frame: 6 months
Change of IOP from baseline will be monitored.
6 months
Cataract progression (if applicable)
Time Frame: 6 months
For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Allergan
Unity Health Toronto

Investigators

  • Principal Investigator: Peter J Kertes, MD,CM,FRCSC, SunnyBrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OZ123 (Other Identifier: Health Canada)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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