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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Intravitreal Injection once every 8 weeks with 3 initial monthly doses
The Retina Institute
St Louis, Missouri, United States
The Retina Institute
St Louis, Missouri, United States
The Retina Institute
St Louis, Missouri, United States
Safety
The Incidence \& Severity will be assessed during study participation. Baseline medical conditions \& abnormal findings present prior to the patient signing the Informed Consent Form (ICF)will be recorded as pre-existing illnesses in the medical history. Clinical study staff will start assessing subjects for adverse events once the ICF has been signed starting at month 1 and at each monthly visit,and will be instructed to request the adverse event information in a nonspecific, non-suggestive type of questioning. The Investigators will record all adverse events regardless of causality.
Time frame: 12 months
Mean visual acuity (BCVA) at Months 6 and 12
Time frame: Month 6 and Month 12
Mean change in OCT central foveal thickness from baseline at Months 6 and 12
Time frame: Months 6 and 12
Mean change in Macular Volume from baseline at Months 6 and 12
Time frame: Months 6 and 12
Mean change in visual acuity (BCVA) from baseline at Months 6 and 12
Time frame: Months 6 and 12
Mean change in CNV lesion characteristics (size, leakage, etc.) from baseline at Months 6 and 12
Time frame: Months 6 and 12
Proportion of patients with no fluid on OCT (absence of cystic edema and subretinal fluid) at Months 6 and 12
Time frame: Months 6 and 12
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