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Topical Bevacizumab for Preventing Recurrent Pterygium

Primary Purpose

Pterygium, Bevacizumab, VEGF

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
bevacizumab eye drop 0.05%
normal saline 0.9%
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pterygium focused on measuring pterygium, recurrent pterygium, bevacizumab, VEGF, anti-VEGF

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of medicine, Chulalongkorn university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

bevacizumab eye drop

placebo normal saline eye drop

Arm Description

Outcomes

Primary Outcome Measures

rate of recurrence after primary pterygium removal

Secondary Outcome Measures

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.

Full Information

First Posted
December 1, 2010
Last Updated
April 6, 2013
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01311960
Brief Title
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

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Bevacizumab, VEGF, Anti-VEGF
Keywords
pterygium, recurrent pterygium, bevacizumab, VEGF, anti-VEGF

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab eye drop
Arm Type
Experimental
Arm Title
placebo normal saline eye drop
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab eye drop 0.05%
Other Intervention Name(s)
Study arm
Intervention Description
bevacizumab eye drop 0.05% will apply 4 times a day for 3 months
Intervention Type
Drug
Intervention Name(s)
normal saline 0.9%
Other Intervention Name(s)
placebo arm
Intervention Description
normal saline eye drop 0.9% will apply 4 times a day for 3 months.
Primary Outcome Measure Information:
Title
rate of recurrence after primary pterygium removal
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability
Description
Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ngamjit Kasetsuwan, MD
Organizational Affiliation
Chulalongkorn Universitiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Chulalongkorn university
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26409291
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.
Results Reference
derived

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Topical Bevacizumab for Preventing Recurrent Pterygium

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