Ocular Histoplasmosis Syndrome
Conditions
Keywords
Histoplasmosis, Lucentis, Ranibizumab, OHS
Brief summary
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.
Detailed description
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
Interventions
DRUGranibizumab
3 monthly injections of ranibizumab followed by prn injections for the remainder of the study
Sponsors
Genentech, Inc.
Retina Associates of Kentucky
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence and severity of ocular adverse events as identified by eye examination | 1 year |
| incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs | 12 mos |
Secondary
| Measure | Time frame |
|---|---|
| mean change in visual acuity | 1 year |
| mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography | 6 and 12 months |
| change in fluorescein angiographic outcomes | 12 months |
| mean number of injections | 12 mos |
Countries
United States
Contacts
Primary ContactDiana Holcomb, COA
Backup ContactWanda Heath, BS, COT, CCRC
Outcome results
None listed