NCT01701518

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

3.4 years

First QC Date

October 3, 2012

Last Update Submit

January 4, 2016

Conditions

Epiretinal MembraneMacular Edema

Keywords

OzurdexDexamethasoneEpiretinal membraneMacular edema

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Best corrected visual acuity at 1,4 and 6 months

    6 months

  • Retinal thickness and volume

    6 months

  • Intraocular pressure (IOP)

    6 months

  • Cataract progression (if applicable)

    6 months

Study Arms (1)

Ozurdex

OTHER

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

Drug: Ozurdex

Interventions

OzurdexDRUG

biodegradable 0.7mg dexamethasone implant

Also known as: 0.7mg dexamethasone implant
Ozurdex

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

RECRUITING

MeSH Terms

Conditions

Epiretinal MembraneMacular Edema

Interventions

Calcium DobesilateDexamethasone

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Peter J Kertes, MD,CM,FRCSC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlene Muller

CONTACT

416-480-5091charlene.muller@sunnybrook.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

CA(2)