Macular Edema Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Allergan, St. Michael's Hospital, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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. | 6 months | No |
Secondary | 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). | 6 months | No |
Secondary | Intraocular pressure (IOP) | Change of IOP from baseline will be monitored. | 6 months | Yes |
Secondary | Cataract progression (if applicable) | For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored. | 6 months | Yes |
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