Official Title
Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
Phase
Phase 1/Phase 2Lead Sponsor
Retina Associates of KentuckyStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Ocular Histoplasmosis SyndromeIntervention/Treatment
ranibizumab ...Study Participants
20The 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:
You are pregnant or intending to become pregnant in the next 12 months or are nursing an infant
You are under the age of 18
prn injections of ranibizumab throughout the study
3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
3 monthly injections of ranibizumab followed by prn injections
injections of ranibizumab on a prn basis from the start of the study
Inclusion Criteria: age 18 or over active choroidal neovascularization secondary to ocular histoplasmosis Visual acuity between 20/25 and 20/400 Exclusion Criteria: pregnancy or intent to become pregnant within the next 12 months nursing an infant premenopausal women not using contraception prior treatment with subfoveal thermal laser allergy to sodium fluorescein simultaneous participation in another investigation or trial