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

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01701518
• Other study ID #: OZ123
• Secondary ID: OZ123
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2012
• Last updated: January 4, 2016
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Sunnybrook Health Sciences Centre
• Contact: Charlene Muller
• Phone: 416-480-5091
• Email: charlene.muller[@]sunnybrook.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiretinal Membrane
• Macular Edema

Intervention

Drug:
• Ozurdex
biodegradable 0.7mg dexamethasone implant

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Allergan, St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity	Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.	3 Months	No
Secondary	Best corrected visual acuity at 1,4 and 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	No
Secondary	Retinal thickness and volume	Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).	6 months	No
Secondary	Intraocular pressure (IOP)	Change of IOP from baseline will be monitored.	6 months	Yes
Secondary	Cataract progression (if applicable)	For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.	6 months	Yes