A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion

Currently there is limited treatment for macular edema and vision loss due to central
retinal vein occlusion. Case reports have shown some benefit of intravitreal steroid
injections in improving vision and reducing macular edema in eyes with retinal vein
occlusions.

Recently, a sustained drug release steroid implant has been investigated and FDA approved to
treat macular edema in patients with non-infectious uveitis, eye inflammation. This implant
is placed through an incision in the eye wall and is designed to deliver a steroid,
fluocinolone acetonide, for up to three years. In animal studies there was no detectable
steroid seen in the blood stream.

This pilot trial will recruit individuals who have had a central retinal vein occlusion in
at least one eye. If the macular edema and vision improves with an initial intravitreal
injection, the eye will be considered to receive the sustained drug release device. The
dosage of fluocinolone acetonide used is 0.59 mg.

Inclusion Criteria:

Patients are eligible to receive an implant if they met all the following criteria:

- A history of central retinal vein occlusion that had caused macular edema, based on
clinical evaluation and demonstrated on fundus photography, fluorescein angiography,
and optical coherence tomography (OCT)

- Macular edema at least one disc area in size that involved the fovea

- Males and non-pregnant females at least 18 years of age

- IOP controlled at < 21 mmHg with no more than one topical ocular antihypertensive
agent

- Ability and willingness to comply with treatment and follow up process and to
understand and sign the informed consent form.

- Initially, patients with central retinal vein occlusion were not required to have
previous therapy. However, the protocol was subsequently modified to require an
intravitreal injection of triamcinolone acetonide > 12 weeks prior to study entry,
with an initial decrease in macular edema and improvement in visual acuity and
subsequent decline in visual acuity accompanied by increased macular edema. This
modification was added to avoid enrolling patients who might have had a long-lasting
response to a single intravitreal triamcinolone acetonide injection.

Exclusion Criteria:

- Patients are excluded if they have an allergy to fluocinolone acetonide or any
component of the delivery system, a peripheral retinal detachment in the area of
implantation, or media opacity precluding evaluation of study eye status.

- Patents with disciform scars of the fovea or atrophic changes of the macula that in
the investigator's opinion would preclude benefit from treatment are excluded from
the study.

- Female patients who were pregnant or lactating or not taking precautions to avoid
pregnancy.