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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Allergan; St. Michael's Hospital, Toronto; Unity Health Toronto
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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.