Diabetic Macular Edema Treated With Ozurdex (DMEO)

Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules
targeting vascular endothelial factor (VEGF). One potential advantage of OZURDEX over
specific VEGF antagonists is that steroids suppress production of multiple pro-permeability
factors.

It is important to test the effect of OZURDEX in patients who have had a suboptimal response
to VEGF antagonists to determine if OZURDEX provides more sustained benefit and to
simultaneously assess its effect on aqueous levels of pro-permeability factors.

Our primary objective is to measure the pro-permeability factors VEGF, SDF-1, and
angiopoietin-2 in the aqueous humor of patients with persistent/recurrent macular edema
despite prior treatment with anti-VEGF agents at baseline and at 1, 2, 3, and 4 months after
intraocular injection of OZURDEX.

Inclusion Criteria:

- • Signed informed consent and authorization of use and disclosure of protected health
information

- Age more than or equal to 18 years

- Diagnosis of diabetic macular edema

- Intraretinal or subretinal fluid in the macula determined by Spectralis OCT

- Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive
(Snellen equivalents using the ETDRS protocol at a distance of 4 meters)

- In the opinion of the investigator, decreased vision in the study eye is due to
foveal thickening from DME and not from other obvious causes of decreased vision

- Persistent or recurrent edema despite prolonged treatment with an anti-VEFG
agent

Exclusion Criteria:

- • Scatter laser photocoagulation or macular photocoagulation within 3 months of study
entry in the study eye

- Intraocular surgery in the study eye within 3 months of study entry

- Use of intraocular or periocular injection of steroids in the study eye (e.g.,
triamcinolone) within 4 months of study entry

- Previous use of an anti-VEGF drug within 1 month of study entry

- Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry

- Any condition that the investigator believes would pose a significant hazard to
the subject if investigational therapy were initiated.

- Inability to comply with study or follow up procedures

- History of glaucoma. (Patients who have undergone filtration surgery may be
included)

- Patients with active or suspected ocular or periocular infection, including most
viral diseases of the cornea and conjunctiva, including active epithelial herpes
simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial
infections, and fungal diseases.

- Aphakic eyes with rupture of the posterior lens capsule.

- Eyes with ACIOL and rupture of the posterior lens capsule.

- Patients with hypersensitivity to dexamethasone or to any other components of
the product