Evaluation of OZURDEX® in Patients With Macular Edema Secondary to Retinal Vein Occlusion in China

This is an interventional treatment trial for Macular Edema Read More

Inclusion Criteria:

Inclusion Criteria:

• Patient diagnosed with macular edema due to RVO (either BRVO or CRVO, non-ischemic)
• Retinal thickness ≥ 300 μm by SD-OCT in the central 1 mm macular subfield of the study eye at the Screening visit
• BCVA score of 19 to 73 letters (approximately 20/400 to 20/40 Snellen equivalent) in the study eye measured by ETDRS method at Screening
• < 3 months of macular edema duration
• Treatment-naive patients (ie, have not previously received any treatment for macular edema secondary to RVO)

Exclusion Criteria:

• Uncontrolled systemic disease
• Presence of/history of any ocular condition other than macular edema that affects visual acuity (eg, cataract, severe macular ischemia, foveal atrophy, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, prior macular detachment)
• Any of the following ≤ 3 months before study entry or anticipated need within the coming 3 months:
• Intraocular surgery
• Laser photocoagulation
• Intraocular injection
• Periocular steroid injection
• Vitrectomized eye
• Aphakic eyes with ruptured posterior lens capsule or presence of an ACIOL, iris or transscleral fixated intraocular lens
• History of marked IOP elevation in response to steroid treatment that (a) required IOP-lowering treatment, (b) resulted in a >10 mm Hg increase in IOP from predose, or (c) resulted in IOP >25 mm Hg
• History of glaucoma or ocular hypertension (IOP > 21 mm Hg), or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye (patients with a history of previous angle closure that has been successfully treated with either a laser or surgical peripheral iridotomy [PI] are allowed as long as the visual fields have been stable for > 1 year prior to study entry and the patient has been and can be safely dilated).
• Any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at the Screening visit
• Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
• Any condition that may interfere or preclude participation in the study
• Use of systemic steroids (e.g., oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to Baseline or anticipated use at any time during the study (inhaled, intranasal, and intra-articular/intrabursal corticosteroids are allowed)
• Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to Baseline or anticipated use at any time during the study
• Use of warfarin or heparin within 2 weeks prior to Baseline or anticipated use within the study period
• Known allergy, hypersensitivity or contraindication to the study medication, its components, fluorescein or povidone iodine
• Current enrollment in another drug or device study within 30 days prior to Baseline