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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT01701518

Collaborator

Unity Health Toronto (Other), Allergan (Industry)

Enrollment

Locations

Arm

Duration (Months)

7.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Epiretinal Membrane Macular Edema	Drug: Ozurdex	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Mar 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Best corrected visual acuity [3 Months]
Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.

Secondary Outcome Measures

Best corrected visual acuity at 1,4 and 6 months [6 months]
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 [6 months]
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) [6 months]
Change of IOP from baseline will be monitored.
Cataract progression (if applicable) [6 months]
For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.