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

Information source: Sunnybrook Health Sciences Centre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epiretinal Membrane; Macular Edema

Intervention: Ozurdex (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Sunnybrook Health Sciences Centre

Official(s) and/or principal investigator(s):
Peter J Kertes, MD,CM,FRCSC, Principal Investigator, Affiliation: Sunnybrook Health Sciences Centre

Overall contact:
Charlene Muller, Phone: 416-480-5091, Email: charlene.muller@sunnybrook.ca

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.

Clinical Details

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

Primary outcome: Best corrected visual acuity

Secondary outcome:

Best corrected visual acuity at 1,4 and 6 months

Retinal thickness and volume

Intraocular pressure (IOP)

Cataract progression (if applicable)

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Charlene Muller, Phone: 416-480-5091, Email: charlene.muller@sunnybrook.ca

St. Michael's Hospital, Toronto, Ontario M5C 2T2, Canada; Recruiting
Rajeev Muni, MD, FRCSC, Phone: (416) 867-7422, Email: rajeev.muni@utoronto.ca
Rajeev Muni, MD,FRCSC, Principal Investigator

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada; Recruiting
Charlene Muller, Phone: 416-480-5091, Email: charlene.muller@sunnybrook.ca
Peter J Kertes, MD,CM,FRCSC, Principal Investigator

Additional Information

Starting date: October 2012
Last updated: January 20, 2015

Page last updated: August 23, 2015

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