Clinical trial NCT01311960: Topical Bevacizumab for Preventing Recurrent Pterygium
Official title: Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pterygium
Bevacizumab
VEGF
Anti-VEGF
Keywords: pterygium
recurrent pterygium
bevacizumab
VEGF
anti-VEGF
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of recurrence after primary pterygium removal
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 3 months
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: Faculty of medicine, Chulalongkorn university
state: Bangkok
Study officials:
affiliation: Chulalongkorn Universitiy
name: Ngamjit Kasetsuwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kasetsuwan N, Reinprayoon U, Satitpitakul V. Prevention of recurrent pterygium with topical bevacizumab 0.05% eye drops: a randomized controlled trial. Clin Ther. 2015 Oct 1;37(10):2347-51. doi: 10.1016/j.clinthera.2015.08.023. Epub 2015 Sep 26.