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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00955630 |
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Date of registration:
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07/08/2009 |
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Primary sponsor: |
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Public title:
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Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome
IVL for OHS |
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Scientific title:
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Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00955630 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Diana Holcomb, COA |
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Address:
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Telephone:
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859-263-3900 |
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Email:
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dholcomb@retinaky.com |
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Affiliation:
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Name:
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John Kitchens, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Retina Associates of Kentucky |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ocular Histoplasmosis Syndrome
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Intervention(s)
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Drug: ranibizumab
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Primary Outcome(s)
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incidence and severity of ocular adverse events as identified by eye examination
[Time Frame: 1 year]
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incidence and severity of other adverse events as identified by physical examination, subject reporting, and changes in vital signs
[Time Frame: 12 mos]
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Secondary Outcome(s)
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change in fluorescein angiographic outcomes
[Time Frame: 12 months]
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mean change in central foveal thickness and total macular volume as obtained by ocular coherence tomography
[Time Frame: 6 and 12 months]
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mean change in visual acuity
[Time Frame: 1 year]
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mean number of injections
[Time Frame: 12 mos]
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Secondary ID(s)
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FVF 4147S
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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