Topical Bevacizumab for Preventing Recurrent Pterygium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ngamjit Kasetsuwan, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01311960
First received: December 1, 2010
Last updated: April 6, 2013
Last verified: March 2011

December 1, 2010
April 6, 2013
December 2010
March 2013   (final data collection date for primary outcome measure)
rate of recurrence after primary pterygium removal [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01311960 on ClinicalTrials.gov Archive Site
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported.
Same as current
Not Provided
Not Provided
 
Topical Bevacizumab for Preventing Recurrent Pterygium
Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pterygium
  • Bevacizumab
  • VEGF
  • Anti-VEGF
  • Drug: bevacizumab eye drop 0.05%
    bevacizumab eye drop 0.05% will apply 4 times a day for 3 months
    Other Name: Study arm
  • Drug: normal saline 0.9%
    normal saline eye drop 0.9% will apply 4 times a day for 3 months.
    Other Name: placebo arm
  • Experimental: bevacizumab eye drop
    Intervention: Drug: bevacizumab eye drop 0.05%
  • Experimental: placebo normal saline eye drop
    Intervention: Drug: normal saline 0.9%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01311960
IRB No. 227/53
Yes
Ngamjit Kasetsuwan, Chulalongkorn University
Chulalongkorn University
Not Provided
Principal Investigator: Ngamjit Kasetsuwan, MD Chulalongkorn Universitiy
Chulalongkorn University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP