Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome

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