Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:21 - Any
Updated:4/2/2016
Start Date:October 2007
End Date:April 2010
Contact:Ginny S Nobel, COT
Email:bristudy@barnesretinainstitute.com
Phone:314-367-1278

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Ranibizumab vs PDT for Presumed Ocular Histoplasmosis

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


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
We found this trial at
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Indianapolis, IN
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St. Louis, Missouri 63110
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St. Louis, MO
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