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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epiretinal Membrane Macular Edema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ozurdex

Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane

Group Type OTHER

Ozurdex

Intervention Type DRUG

biodegradable 0.7mg dexamethasone implant

Interventions

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Ozurdex

biodegradable 0.7mg dexamethasone implant

Intervention Type DRUG

Other Intervention Names

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0.7mg dexamethasone implant

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes