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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Allergan
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01701518
First received: October 3, 2012
Last updated: January 20, 2015
Last verified: January 2015

October 3, 2012
January 20, 2015
October 2012
March 2016   (final data collection date for primary outcome measure)
Best corrected visual acuity [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
Same as current
Complete list of historical versions of study NCT01701518 on ClinicalTrials.gov Archive Site
  • Best corrected visual acuity at 1,4 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Best corrected visual acuity measured at 1,4 and 6 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.
  • Retinal thickness and volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).
  • Intraocular pressure (IOP) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Change of IOP from baseline will be monitored.
  • Cataract progression (if applicable) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.
Same as current
Not Provided
Not Provided
 
A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epiretinal Membrane
  • Macular Edema
Drug: Ozurdex
biodegradable 0.7mg dexamethasone implant
Other Name: 0.7mg dexamethasone implant
Ozurdex
Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane
Intervention: Drug: Ozurdex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
December 2016
March 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Charlene Muller 416-480-5091 charlene.muller@sunnybrook.ca
Canada
 
NCT01701518
OZ123, OZ123
No
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
  • St. Michael's Hospital, Toronto
  • Allergan
Principal Investigator: Peter J Kertes, MD,CM,FRCSC Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
January 2015

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