Recruiting

Ozurdex

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT01701518

Conditions

Epiretinal Membrane

Macular Edema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ozurdex

Study Details

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.

Conditions

Epiretinal Membrane

Macular Edema

Study ID

NCT01701518

Start date

Oct, 2012

Status verified date

Jan, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Mar, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Ozurdex

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

Interventions

Ozurdex

biodegradable 0.7mg dexamethasone implant

Primary outcome measure

  • Best corrected visual acuity [ Time Frame: 3 Months ]

Central Contacts and Locations

Central contacts

Charlene Muller

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

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Charlene Muller

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

Principal Investigator:

Peter J Kertes, MD,CM,FRCSC

St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5C 2T2

Contacts

Rajeev Muni, MD, FRCSC

(416) 867-7422rajeev.muni@utoronto.ca

Principal Investigator:

Rajeev Muni, MD,FRCSC

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jan 5, 2016

Last verified

Jan, 2016

Keywords

  • Ozurdex
  • Dexamethasone
  • Epiretinal membrane
  • Macular edema

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2016-01-05.