Pterygium Clinical Trial
Official title:
Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial
Verified date | March 2011 |
Source | Chulalongkorn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of medicine, Chulalongkorn university | Pathumwan | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rate of recurrence after primary pterygium removal | 3 months | Yes | |
Secondary | Number of participants with adverse events as a measure of safety and tolerability | Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported. | 3 months | Yes |
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