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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


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
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