Clinical trial NCT01701518: A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epiretinal Membrane
Macular Edema
Keywords: Ozurdex
Dexamethasone
Epiretinal membrane
Macular edema
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: Allergan
First posted: 2012-10-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 3 Months
Secondary outcomes:
measure: Best corrected visual acuity at 1,4 and 6 months
timeFrame: 6 months
measure: Retinal thickness and volume
timeFrame: 6 months
measure: Intraocular pressure (IOP)
timeFrame: 6 months
measure: Cataract progression (if applicable)
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Peter J Kertes, MD,CM,FRCSC
role: PRINCIPAL_INVESTIGATOR
References: