Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema

This is an open-label, Phase I study of intravitreally administered ranibizumab in 20
subjects with macular edema associated with CRVO. Patients will be evaluated at baseline
with ophthalmic examination, fluorescein angiography, optical coherence tomography, and
color photography. Subjects will receive open-label intravitreal injections of 0.5 mg
ranibizumab administered every 28 ± 2 days for a total of 3 injections. Thereafter they are
to be evaluated every month until month 12. If the patients have signs of increased
intraretinal hemorrhage or a persistence / increase in central macular edema as determined
by optical coherence tomography when compared to their last visit, are eligible for
re-injection at that monthly visit.

Inclusion Criteria:

- Ability to provide written informed consent and comply with study assessments for the
full duration of the study

- Age > 18 years

- Clinical evidence of perfused central retinal vein occlusion. A central retinal vein
occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated
retinal venous system in all 4 quadrants. Other evidence of a CRVO may include
telangiectatic capillary bed and collateral vessels at the optic nerve head. .

- Central macular edema present on clinical examination and OCT testing with a central
point thickness > 250 microns

- Visual acuity score greater than or equal to 34 letters (20/200) and less than or
equal to 73 letters (20/40) by the ETDRS visual acuity protocol.

- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT
testing and retinal photography

Exclusion Criteria:

- Pregnancy (positive pregnancy test) or known to be pregnant, also premenopausal women
not using adequate contraception.

- Participation in another simultaneous ocular investigation or trial

- Patient with uncontrolled hypertension

- Patient has a condition that, in the opinion of the investigator would preclude
participation in the study (i.e. chronic alcoholism, drug abuse)

- Patient has significant diabetic retinopathy (greater than moderate NPDR) or macular
edema associated with diabetic retinopathy

- Exam or OCT reveals evidence of vitreoretinal interface abnormality that may be
contributing to the macular edema

- Eye that in the investigator has no chance of improvement in visual acuity following
resolution of macular edema (i.e subretinal fibrosis or geographic atrophy)

- Any other additional ocular diseases which could irreversibly compromise the visual
acuity of the study eye including amblyopia, anterior ischemic optic neuropathy
(AION), age related macular degeneration (AMD), retinal detachment, severe cataracts,
etc.

- Evidence of neovascularization of the iris or retina (presence of ischemic CRVO)

- History of Grid/Focal laser or Panretinal laser in the study eye

- History of vitreous surgery in the study eye

- History of use of intravitreal, peribulbar, or retrobulbar steroids within six months
of the study.

- History of Cataract Surgery within 6 months of enrollment.

- History of YAG capsulotomy within 2 months of the surgery.

- Visual acuity <20/400 in the fellow eye

- Uncontrolled Glaucoma, pressure >30 despite treatment with glaucoma medications.

- Use of Bevacizumab in either eye within the past 30 days

- Use of Pegaptinib sodium in either eye within the past 6 weeks

- Use of Triamcinolone in either eye

- Have received any other systemic experimental drug within 12 weeks prior to
enrollment.

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