Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

This is an open-label, randomized, one-year, multiple-dose study of 2mg aflibercept in
patients with PCV.

The study consists of the baseline visit on day 0 and a mandatory clinic visit every 30 days
to assess efficacy and safety. All patients will receive three monthly injections of 2mg
intravitreal aflibercept injection followed by treatment every 60 days through 720 days (24
months). Patients can be treated every 30 days if needed.

The fellow eye may be treated with intravitreal aflibercept injection per the investigator's
discretion at any point during the study if evidence of disease activity are met: exudation
or hemorrhage secondary to polypoidal choroidal vasculopathy or exudative AMD. The fellow
eye will not be considered the study eye. If treatment with aflibercept is to be given in
the fellow eye, the injections are to be administered according to the Food and Drug
Administration (FDA) approved label for EYLEA®.

Inclusion Criteria:

- Age > 25 years of age.

- In the opinion of the principal investigator, the study eye has PCV with active
exudation and/or bleeding that may benefit from treatment with study medication.

- Diagnosis of PCV via ICG Angiography with evidence of active leakage, active bleeding
or recent decreased in vision.

- Baseline visual acuity better than or equal to 20/200 using ETDRS

- Willing and able to comply with clinic visits and study-related procedures

- Provide signed informed consent

Exclusion Criteria:

- Any history of previous vitrectomy

- Previous cataract surgery within the preceding 2 months of Day 0

- Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either
eye

- Presence of any condition that would jeopardize the patient's participation in this
study

- Participation in an investigational trial within 30 days of randomization that
involved treatment with any drug that has not received regulatory approval at the
time of study entry

- For the Treatment-Naïve cohort: no prior anti-VEGF (Macugen, Avastin, Lucentis,
Eylea) in the study eye

- For the Previous-Treated cohort: no prior anti-VEGF (Macugen, Avastin, Lucentis) in
the study eye within 30 days or enrollment in this study

- For the Previous-Treated cohort: no prior Eylea in the study eye

- Known allergy to any component of the study drug

- Blood pressure >180/119 (systolic above 180 or diastolic above 110). If blood
pressure is brought below 180/110 by anti-hypertensive treatment, the patient can be
eligible.

- Major surgery within 28 days prior to randomization or major surgery planned within
the next 12 months. Major surgery is defined as a surgical procedure that is more
extensive than needle biopsy/aspiration placement of a central venous access device,
removal/biopsy of a skin lesion, or placement of a peripheral venous catheter

- Myocardial infarction, other cardiac event requiring hospitalization, stroke,
transient ischemic attack, or treatment for acute congestive heart failure within 6
months prior to randomization

- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization

- Pregnant or breast-feeding women

- Simultaneous participation in another medical investigational trial

- Sexually active men* or women of childbearing potential** who are unwilling to
practice adequate contraception during the study (adequate contraceptive measures
include stable use of oral contraceptives or other prescription pharmaceutical
contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device
[IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam,
or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)