Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

Inclusion Criteria:

- CNV of less than 1 year duration due to presumed ocular histoplasmosis

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

- Age 21 years and older

- Subfoveal or juxtafoveal CNV lesion of less than 5400um in diameter

- Best corrected visual acuity of 20/25 to 20/400

- Birth control therapy for females of child-bearing age

Exclusion Criteria:

- CNV due to presumed ocular histoplasmosis for greater than 1 year

- Pregnancy (positive 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 IUD, or contraceptive hormone implant or patch

- A recent history of smoking (within 1 year of study enrollment)

- Prior treatment with intravitreal aflibercept injection

- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated

- Uncontrolled glaucoma in the study eye (defined as IOP greater or equal to 30 mmHg
despite treatment with anti-glaucoma medication)

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

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

- Presence of significant subfoveal fibrosis or atrophy

- Intraocular surgery (including cataract surgery) in the study eye within 2 months of
enrollment

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

- History of allergy to fluorescein, ICG or iodine, not amendable to treatment

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

- Require medical or surgical intervention during the 12 month study period to prevent
or treat visual loss that might result from that condition, or

- If allowed to progress untreated, could likely contribute to loss of at least 2
snellen equivalent lines of BCVA over the 12 month study period

- Prior/Concomitant Treatment:

- Panretinal photocoagulation treatment

- Previous intraocular steroids or PDT within 3 months

- Previous participation in any studies of investigational drugs within 30 days
preceding Day 0 (excluding vitamins and minerals)

- Previous treatment with intravitreally (in either eye) or intravenously administered
Avastin (bevacizumab) within 60 days

- Previous use of Macugen or Lucentis in study eye within 60 days

- Prior submacular or vitreous surgery