The purpose of this study is to evaluate the safety and effectiveness of intravitreal ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular histoplasmosis.
Patients will be evaluated monthly for one year. Participants will be assigned to one of two groups: Group A will receive 3 monthly injections of ranibizumab followed by an as needed injection throughout the remainder of the study Group B will receive injections of ranibizumab on an as needed basis throughout the study You cannot take part in this study if: 1. You are pregnant or intending to become pregnant in the next 12 months or are nursing an infant 2. You are under the age of 18
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
prn injections of ranibizumab throughout the study
Retina Associates of Kentucky
Lexington, Kentucky, United States
RECRUITINGincidence and severity of ocular adverse events as identified by eye examination
Time frame: 1 year
incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs
Time frame: 12 mos
mean change in visual acuity
Time frame: 1 year
mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography
Time frame: 6 and 12 months
change in fluorescein angiographic outcomes
Time frame: 12 months
mean number of injections
Time frame: 12 mos
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