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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: |
NCT00596362 |
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Date of registration:
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08/01/2008 |
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Primary sponsor: |
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Public title:
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Treatment With Intravitreal Avastin for Large Uveal Melanomas
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Scientific title:
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Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00596362 |
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Study type:
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Interventional |
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Study design:
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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients diagnosed with large uveal melanomas who elect to undergo enucleation.
- Patients diagnosed with uveal melanomas with tumor thickness > 10 mm or basal
diameter > 16 mm, as measured by ultrasound examination, funduscopic examination, or
transillumination.
Exclusion Criteria:
- Cases that do not meet the above criteria for tumor size will be ineligible to
participate in the study.
- Patients with history of metastatic cancer (other than melanoma).
- Patients not able to provide consent for the study.
- Patients with clinical or radiographic evidence of extraocular extension of the
tumor.
- Patients with a previous history of an adverse reaction to intravitreal injection.
- Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
- Patients with intravitreal silicone oil or gas tamponade.
- Patients < 18 years of age.
- Women known to be pregnant.
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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Uveal Melanoma
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Intervention(s)
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Drug: AVASTIN
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Primary Outcome(s)
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To examine the response of intravitreal Avastin in causing a clinically significant reduction in uveal melanoma tumor size (base height and volume).
[Time Frame: conclusion of study]
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Secondary Outcome(s)
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To examine the short-term safety profile of intravitreal injection of Avastin in patients with intraocular tumors.
[Time Frame: conclusion of study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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