Suspended

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

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What is being tested

Ozurdex

Drug
Who is being recruted

Eye Diseases+3

+ Macular Degeneration

+ Retinal Degeneration

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorSunnybrook Health Sciences Centre
Study ContactCharlene MullerMore contacts
Last updated: January 5, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01701518
Principal SponsorSunnybrook Health Sciences Centre
Study ContactCharlene MullerMore contacts
Last updated: January 5, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesMacular EdemaEpiretinal Membrane

Criteria

5 inclusion criteria required to participate
Age more than 18 years old
Central retinal thickness >= 250 μm
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
Show More Criteria
10 exclusion criteria prevent from participating
Any other macular pathology that could affect anatomic or functional results
History of moderate or advanced glaucoma (cup to disc ratio >= 0.7)
History of steroid-responsive glaucoma
History of uveitis requiring intravitreal triamcinolone injection
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Sunnybrook Health Sciences Centre

Toronto, CanadaOpen Sunnybrook Health Sciences Centre in Google Maps
Recruiting

St. Michael's Hospital

Toronto, Canada
Suspended2 Study Centers