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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: |
NCT01311960 |
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Date of registration:
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01/12/2010 |
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Primary sponsor: |
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Public title:
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Topical Bevacizumab for Preventing Recurrent Pterygium
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Scientific title:
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Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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24 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01311960 |
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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: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Ngamjit Kasetsuwan, MD |
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Address:
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Telephone:
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662-256-4142 |
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Email:
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ngamjitk@gmail.com |
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Affiliation:
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Name:
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Ngamjit Kasetsuwan, MD |
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Address:
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Telephone:
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662-256-4142 |
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Email:
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ngamjitk@gmail.com |
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Affiliation:
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Name:
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Ngamjit Kasetsuwan, 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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Chulalongkorn Universitiy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who are diagnosed with primary pterygium and plan for pterygium excision
with bare sclera by single surgeon. (G.N.)
- Patients with pterygium who understand and can follow the study protocol.
- Patients of age more than 30 years
Exclusion Criteria:
- Patients who have corneal melt, corneal epitheliopathy, abnormal corneal epithelial
wound healing.
- Patients who are pregnancy or lactation.
- Patients who have a history of allergy to bevacizumab.
- Patients who have a history of allergy to steroid eye drops
Age minimum:
30 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anti-VEGF
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Bevacizumab
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Pterygium
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VEGF
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Intervention(s)
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Drug: bevacizumab eye drop 0.05%
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Drug: normal saline 0.9%
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Primary Outcome(s)
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rate of recurrence after primary pterygium removal
[Time Frame: 3 months]
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Secondary Outcome(s)
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Number of participants with adverse events as a measure of safety and tolerability
[Time Frame: 3 months]
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Secondary ID(s)
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IRB No. 227/53
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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