Intravitreal Aflibercept Injection (IAI) for Presumed Ocular Histoplasmosis Syndrome
United States5 participantsStarted 2012-06
Plain-language summary
The purpose of this study is to assess the efficacy and safety of intravitreal injection of aflibercept for the treatment of Choroidal Neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS).
Who can participate
Age range21 Years
SexALL
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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
* Presenc…