Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to Retinal Vein Occlusion

Dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) and
Ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) as needed group:

- Patients will receive a dexamethasone intravitreal implant injection at day 0.
Injection procedure will be identical to those previously described.8,19,20 Topical
tetracaine drops will be given, a lid speculum inserted, and then 5% povidone iodine
drops will be given. After subconjunctival injection of 2% lidocaine, the 0.7mg DEX
implant will be inserted through the pars plana using a customized, single use,
22-gauge applicator. Patients will be treated with topical ophthalmic antibiotics four
times daily for three days after the procedure.

- During monthly visits 1,2,3, and 5, patients will receive a ranibizumab intravitreal
injection if the macula SD-OCT during that visit shows mean central foveal thickness ≥
250 μm or the best-corrected visual acuity is 20/40 or worse. The injection procedure
is described in the next section.

- During monthly visit 4, patients will receive a dexamethasone intravitreal implant
injection if the macula SD-OCT during that visit shows mean central foveal thickness ≥
250 μm or the best-corrected visual acuity is 20/40 or worse.

Monthly Ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) group:

- Patients will receive a ranibizumab intravitreal injection on day 0. During each other
visit, patients will receive a ranibizumab intravitreal injection. The protocol will
use the term "monthly" to represent a 30 day interval between treatments. The minimal
interval between treatments may be 25 days.

- Injection procedures will be identical to those previously described.8,19,20 Topical
tetracaine drops will be given, a lid speculum inserted, and then 5% povidone iodine
drops will be given. After subconjunctival injection of 2% lidocaine, a 30-gauge needle
will be inserted through the pars plana, and 0.5 mg (0.05mL) of drug injected.

Inclusion Criteria:

- Signed informed consent form

- 18 to 90 year-old men or women

- Women must be postmenopausal for at least 12 months before study enrollment, or
surgically sterile. Potential child bearing women must have a negative serum
pregnancy test within 14 days prior to the first treatment and practice effective
contraception during and at least 120 days following the last dose of injection.

- Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina
offices.

- Healthy enough to participate in the study.

- Willing and able to consent to participation in the study.

- Retinal vein occlusion:

- Must be diagnosed within two weeks of onset of symptoms

- Best Corrected Visual Acuity (BCVA) on initial presentation between 20/40 and 20/320

- No contraindications to intravitreal injection of dexamethasone implant or
ranibizumab

- Central foveal thickness greater than 250 m on Spectral Domain-OCT

Exclusion Criteria:

- Unknown duration of symptoms prior to diagnosis.

- Patients with any history of prior intravitreal dexamethasone or anti-VEGF or grid
laser.

- Patients with diabetic retinopathy.

- Patients with age-related macular degeneration.

- Patients with an optic neuropathy.

- Patients with a retinal detachment or history of retinal detachment.

- Patients with a significant epiretinal membrane.

- Patients with a history of choroidal neovascularization.

- Patients with glaucoma with visual field loss documented on a Humphrey Visual Field
test or ocular hypertension requiring more than 2 medications to control IOP in the
study eye.

- Patients with a clinically significant media opacity.

- Patients using or anticipating using systemic steroids.

- Patients with any uncontrolled systemic disease.

- Patients with aphakia or anterior-chamber intraocular lens.

- Patients with active neovascularization of the iris, disc, or retina.