Intense Treatment Regimen With Intravitreal Aflibercept Injection

The development of biologic therapy targeting VEGF has been revolutionary and has lowered the
rate of functional blindness in many developed countries. Modalities to treat nvAMD have been
based on monthly dosing. For many patients, this modality is adequate and they can achieve a
dry macula. A subset of patients can even have their treatment intervals extended. There is,
however, a subset of patients with recalcitrant neovascularization for whom IAI fails to
produce a dry macula even with q4w dosing. An intense dosing schedule for a short period of
time could decrease fluid activity in these patients.

Inclusion Criteria:

- Age ≥ 50 years

- Choroidal neovascularization related to age-related macular degeneration

- Prior treatment with any anti-VEGF agent for ≥ 12 months

- Prior treatment with at least five consecutive IAI at baseline with an average
treatment interval of maximum 35 days

- Presence of foveal fluid at most recent clinical visit occurring 30 (+/- 5) days
following the most recent IAI

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

- Provide signed informed consent

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

- Monocular patients

- Patients with a previous history of macular thermal laser or PDT

- Confounding ocular conditions in the study eye that may affect interpretation of OCT,
BCVA or assessment of macular appearance (eg. cataract, epiretinal membrane, retinal
vascular occlusive disease)

- Intraocular surgery (including cataract surgery) in the study eye within 2 months
preceding baseline

- History of vitrectomy surgery, submacular surgery, or other surgical intervention for
AMD in the study eye

- Active intraocular inflammation (grade trace or above) in the study eye

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

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

- History of cerebral vascular accident, myocardial infarction, transient ischemic
attacks within 3 months of study enrollment

- Patients on systemic anti-VEGF treatment

- Pregnant or breastfeeding women

- Sexually active men* or women of childbearing potential** who are unwilling to
practice adequate contraception prior to the initial dose/start of the first
treatment, during the study, and for at least 3 months after the last dose. 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; bilateral tubal ligation; vasectomy; condom plus contraceptive
sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.

- *Contraception is not required for men with documented vasectomy.

- **Postmenopausal women must be amenorrheic for at least 12 months in order not to
be considered of childbearing potential. Pregnancy testing and contraception are
not required for women with documented hysterectomy or tubal ligation.