Aflibercept Injection for Proliferative Diabetic Retinopathy

Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will
receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of
these patients will be randomized to receive another injection of 2.0mg aflibercept
immediately after their surgery. Postoperative patient visits in this study will be at 1
day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the
Investigator.

Inclusion Criteria:

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

- Age > 18 years

- Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana
vitrectomy (PPV)

- Best corrected visual acuity in the study eye between 20/40 to light perception (LP)
using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria:

- Pregnancy (positive urine pregnancy test) or lactation

- Premenopausal women not using adequate contraception. The following are considered
effective means of contraception: surgical sterilization or use of oral
contraceptives, barrier contraception with either a condom or diaphragm in
conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive
hormone implant or patch.

- Participation in a study of an investigational drug or device within the past 30 days
prior to enrolling in the study

- For previously treated subjects -

- Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in
the study eye within 28 days of Screening

- Prior treatment with triamcinolone in the study eye within 6 months of Screening.

- Prior treatment with dexamethasone in the study eye within 30 days of Screening

- 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
PDR 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

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

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

- History of cerebral vascular accident, myocardial infarction, transient ischemic
attacks within 6 months of study enrollment.

- History of allergy to fluorescein, indocyanine green (ICG) or iodine, not amenable to
treatment

- Presence of macular traction

- Uncontrolled hypertension (e.g., 120/200 mmHg) prior to surgery (PPV)

- Concomitant use of any systemic anti-VEGF therapy