Topical Bevacizumab for Preventing Recurrent Pterygium
|Pterygium Bevacizumab VEGF Anti-VEGF||Drug: bevacizumab eye drop 0.05% Drug: normal saline 0.9%||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial|
- rate of recurrence after primary pterygium removal [ Time Frame: 3 months ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 3 months ]Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported.
|Study Start Date:||December 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
|Experimental: bevacizumab eye drop||
Drug: bevacizumab eye drop 0.05%
bevacizumab eye drop 0.05% will apply 4 times a day for 3 months
Other Name: Study arm
|Experimental: placebo normal saline eye drop||
Drug: normal saline 0.9%
normal saline eye drop 0.9% will apply 4 times a day for 3 months.
Other Name: placebo arm
A pterygium is a degenerative and proliferative fibrovascular disorder of the ocular surface. Patients may be asymptomatic, irritation, decreased vision, diplopia or limit ocular movement. The mainstay treatment is surgical removal of the head, neck and body of the pterygium. However, if there is no adjunctive treatment, the recurrence is unacceptably high which is 63% in general. Various adjunctive measures are applied to prevent recurrence including use of mitomycin C, beta-irradiation and surgical methods such as conjunctival and amniotic membrane graft. However, each method has its advantages and disadvantages.
The histologic finding of recurrent pterygium often has aggressive fibrovascular growth. Vascular endothelial growth factor(VEGF)has been detected in increased amounts in pterygium tissue, compared with normal conjunctiva and it is also correlated with post-operative recurrence. Bevacizumab, an Anti-VEGF, binds to VEGF and prevents the interaction of VEGF to its receptors on the surface of vascular endothelial cells. Administration of bevacizumab leads to inhibition of endothelial cell proliferation and new blood vessel formation. Even though there are reported the efficacy of topical bevacizumab in inhibiting the impending recurrent pterygium, there is no study for preventing recurrence after primary pterygium removal.
We conduct a prospective, randomized, double-masked, controlled trial to evaluate the efficacy of topical bevacizumab 0.05% eye drops for preventing recurrence in primary pterygium.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311960
|Faculty of medicine, Chulalongkorn university|
|Pathumwan, Bangkok, Thailand, 10330|
|Principal Investigator:||Ngamjit Kasetsuwan, MD||Chulalongkorn Universitiy|