Repeated Eye Injections of Aflibercept for Treatment of Wet Age Related Macular Degeneration

The purpose of this study is to see how using "treat and extend," a method of determining how
often a patient with NVAMD should visit the retina clinic and receive treatments, affects
vision in patients with this condition after treatment. The treatment the investigators are
using in this study is an eye injection of a drug called aflibercept (also called EYLEA).
Eylea is FDA (Food and Drug Administration) approved for treatment of wet age related macular
degeneration.

The investigators hope that "treat and extend" strikes the right balance between making sure
patients get all of the treatments needed, but not giving patients too many treatments (so
that the side effects of treatments are minimized and so that patients don't have to make
more visits than they need to maintain maximum visual gain). The experimental part of this
study is determining this "right balance" of eye injections.

Inclusion Criteria:

- Patients older than 55 years with treatment naïve, active subfoveal NVAMD
demonstrating macular fluid on optical coherence tomography (OCT) and leakage on
fluorescein angiography (FA).

- Only one eye for each patient demonstrating a pre-treatment acuity of 20/25 - 20/320
is eligible

- Patients cannot have concurrent progressive retinal disease in the study eye.

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

- Provide signed informed consent

Exclusion Criteria:

- Prior treatment for NVAMD in the study eye,

- Prior experimental treatment of NVAMD in either eye

- Prior treatment with systemic anti-VEGF (vascular endothelial growth factor) agents

- Prior treatment with verteporfin, plaque brachytherapy, or external-beam radiation
therapy, or transpupillary thermotherapy in the study eye

- Previous subfoveal focal laser photocoagulation involving the foveal center in the
study eye

- History of vitreo surgical intervention in the study eye. Cataract surgery is
permitted.

- Concurrent eye disease in the study eye that could compromise visual acuity (e.g.
diabetic retinopathy, advanced glaucoma)

- Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or
glaucoma) that, in the opinion of the investigator, could either

- require medical or surgical intervention during the 52 weeks study period to prevent
or treat visual loss that might result from that condition, or

- allowed to progress untreated, could likely contribute to loss of at least 2 Snellen
equivalent lines of best corrected visual acuity over the 52 weeks study period

- Active intraocular inflammation (grade trace or above) in the study eye, or history of
idiopathic or autoimmune-associated uveitis in either eye

- Current vitreous hemorrhage in the study eye

- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the
study eye

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

- Aphakia, Anterior Chamber Intraocular Lens (ACIOL), or unstable Posterior Chamber
Intraocular Lens (PCIOL).

- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg
despite treatment with anti-glaucoma medication)

- Pregnant or breast-feeding women

- 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)