Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant
versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular
edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.

Inclusion Criteria:

- Presence of NPDR or PDR as confirmed by fluorescein angiography

- Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last
4 weeks

- < 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit
and following treatment with >= 2 intravitreal anti-VEGF injections

- Age 18 years or older

- ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25
to 20/800)

- Ability to provide written informed consent

- Capable of complying with study protocol.

Exclusion Criteria:

- Intraocular injection of steroid medication within prior 3 months

- Evidence of significant geographic atrophy on fluorescein angiography in the opinion
of the treating physician

- Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual
acuity in the opinion of the treating physician

- Prior vitrectomy surgery

- Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or
extensive dermal) within 1 month prior to day 1.

- Known history of IOP elevation in response to steroid treatment in either eye that
resulted in any of the following: a) = 10 mm Hg increase in IOP in response to
steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma
medications to keep IOP below 21 mm Hg.

- Patients who are pregnant.

- Unwilling or unable to follow or comply with all study related procedures