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