Topical Bevacizumab for Preventing Recurrent Pterygium | NCT01311960

Studies
Topical Bevacizumab for Preventing Recurrent Pterygium

NCT01311960

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

Apr 9, 2013Estimated

Enrollment

24Actual

Phase

Phase 3

Conditions

Pterygium
Bevacizumab
VEGF
Anti-VEGF

Interventions

bevacizumab eye drop 0.05%
normal saline 0.9%

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Mar 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Dec 1, 2010

First Submission Date that Met QC Criteria

Mar 8, 2011

First Posted Date

Mar 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2013

Last Update Posted Date

Apr 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ngamjit Kasetsuwan, Associated professor, Chulalongkorn UniversityPrincipal Investigator

Lead Sponsor

Chulalongkorn UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bevacizumab eye drop	Experimental		Drug: bevacizumab eye drop 0.05%
placebo normal saline eye drop	Experimental		Drug: normal saline 0.9%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab eye drop 0.05%	Drug	bevacizumab eye drop 0.05% will apply 4 times a day for 3 months	bevacizumab eye drop

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of recurrence after primary pterygium removal		3 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ngamjit Kasetsuwan, MD	Chulalongkorn Universitiy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine, Chulalongkorn university		Pathumwan	Bangkok	10330	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26409291	Derived	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.

ID	Term
D003229	Conjunctival Diseases
D005128	Eye Diseases

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations