Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome

Study Overview
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Brief Summary
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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
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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

Official Title
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Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome

Conditions
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Ocular Histoplasmosis Syndrome

Intervention / Treatment
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* Drug: ranibizumab
* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monthly injections<br>3 monthly injections of ranibizumab followed by prn injections | Drug: ranibizumab<br>* 3 monthly injections of ranibizumab followed by prn injections for the remainder of the study<br>* Other names: Lucentis;|
| Active Comparator: PRN injections<br>injections of ranibizumab on a prn basis from the start of the study | Drug: ranibizumab<br>* prn injections of ranibizumab throughout the study<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Histoplasmosis, Lucentis, Ranibizumab, OHS