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

Primary Purpose

Epiretinal Membrane, Macular Edema

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Ozurdex

About this trial

This is an interventional treatment trial for Epiretinal Membrane focused on measuring Ozurdex, Dexamethasone, Epiretinal membrane, Macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Sunnybrook Health Sciences CentreRecruiting
St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ozurdex

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

Intraocular pressure (IOP)

Change of IOP from baseline will be monitored.

Cataract progression (if applicable)

For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.

Full Information

NCT ID

NCT01701518

First Posted

October 3, 2012

Last Updated

January 4, 2016

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Unity Health Toronto, Allergan

1. Study Identification

Unique Protocol Identification Number

NCT01701518

Brief Title

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

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Unity Health Toronto, Allergan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epiretinal Membrane, Macular Edema

Keywords

Ozurdex, Dexamethasone, Epiretinal membrane, Macular edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ozurdex

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ozurdex

Other Intervention Name(s)

0.7mg dexamethasone implant

Intervention Description

biodegradable 0.7mg dexamethasone implant

Primary Outcome Measure Information:

Title

Best corrected visual acuity

Description

Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.

Time Frame

3 Months

Secondary Outcome Measure Information:

Title

Best corrected visual acuity at 1,4 and 6 months

Description

Best corrected visual acuity measured at 1,4 and 6 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.

Time Frame

6 months

Title

Retinal thickness and volume

Description

Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).

Time Frame

6 months

Title

Intraocular pressure (IOP)

Description

Change of IOP from baseline will be monitored.

Time Frame

6 months

Title

Cataract progression (if applicable)

Description

For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charlene Muller

Phone

416-480-5091

charlene.muller@sunnybrook.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter J Kertes, MD,CM,FRCSC

Organizational Affiliation

Sunnybrook Health Sciences Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Charlene Muller

Phone

416-480-5091

charlene.muller@sunnybrook.ca

First Name & Middle Initial & Last Name & Degree

Peter J Kertes, MD,CM,FRCSC

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C 2T2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rajeev Muni, MD, FRCSC

Phone

(416) 867-7422

rajeev.muni@utoronto.ca

First Name & Middle Initial & Last Name & Degree

Rajeev Muni, MD,FRCSC

12. IPD Sharing Statement

Learn more about this trial

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

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