Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the change in visual activity of ranibizumab to Photodynamic Therapy (PDT)in patients with choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis

Official Title
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Ranibizumab vs PDT for Presumed Ocular Histoplasmosis

Conditions
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Presumed Ocular Histoplasmosis (POHS)

Intervention / Treatment
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* Drug: ranibizumab
* Drug: verteporfin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subfoveal CNV due to presumed ocular histoplasmosis of less than 1 year duration Ability to provide written informed consent and comply with study assessments for the full duration of the study Age greater than or equal to 21 years of age CNV lesion of than < 5400 microns in diameter Best corrected visual acuity of 20/40-20/320 Birth control therapy for females of child-bearing potential Exclusion Criteria: Subfoveal NCV due tp presumed ocular histoplasmosis for > 1 year Pregnancy or lactation premenopausal women not using adequate contraception Prior enrollment in the study Any other condition that the Investigator believes would pose a significant hazard to the subject Participation in another simultaneous medical investigation or trial Participation in another trial or previous trial of ranibizumab or Avastin Any concurrent ocular condition in the study eye (cataract, diabetic retinopathy)that could require medical or surgical intervention or ifa allowed to progress, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period Previous panretinal photocoagulation Previous steroids or PDT in 3 months Previous participation in any studies of investigational drugs within 30 days preceding Day 0 Prior participation in a Genentech ranibizumab clinical trial Previous treatment with intravitreally (in either eye) or intravenously administered Avastin within 3 months Previous use of Macugen in the study eye within 3 months Prior submacular surgery

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ranibizumab intravitreal injection<br>0.5 mg intravitreal injection of ranibizumab | Drug: ranibizumab<br>* 0.5mg ranibizumab<br>|
| Active Comparator: Photodynamic Therapy<br>Photodynamic therapy with Visudyne | Drug: verteporfin<br>* Photodynamic therapy with verteporfin every 3 months for 1 year<br>* Other names: Visudyne;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in visual acuity |  | 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate mean change in vision at 6 months |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Histoplasmosis