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Intralesional Bevacizumab Injection on Primary Pterygium (bevacizumab)

Primary Purpose

Pterygium, Inflammation

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Intralesional injection of bevacizumab
Topical antihistamine and vasoconstrictor
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring bevacizumab, pterygium, treatment, elevation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary pterygium

Exclusion Criteria:

  • previous ocular surgery

Sites / Locations

  • Srinagarind HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

bevacizumab

Topical antihistamine and vasoconstrictor

Arm Description

intralesional bevacizumab injection

combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%

Outcomes

Primary Outcome Measures

percentage of corneal pterygium area
Prior to receive the treatments, patients were asked to evaluate grading of their own symptoms and underwent clinical grading of the elevation and inflammation of the lesions using slit lamp biomicroscopy by an opthalmologist (OE). Digital photographs of each eye with pterygium were obtained for corneal pterygium area analysis [Sony Mavica digital still camera MVC-FD83, Japan]. Each patient was randomly assigned into either treatment group or control group using computer-generated random numbers table. Number of patients with adverse events will be recorded.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2010
Last Updated
July 7, 2011
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT01380678
Brief Title
Intralesional Bevacizumab Injection on Primary Pterygium
Acronym
bevacizumab
Official Title
A Randomized Controlled Trial of Intralesional Bevacizumab Injection on Primary Pterygium: Preliminary Results
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms.
Detailed Description
To evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Inflammation
Keywords
bevacizumab, pterygium, treatment, elevation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab
Arm Type
Active Comparator
Arm Description
intralesional bevacizumab injection
Arm Title
Topical antihistamine and vasoconstrictor
Arm Type
Active Comparator
Arm Description
combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%
Intervention Type
Drug
Intervention Name(s)
Intralesional injection of bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
single dose of 2 mg of bevacizumab intralesional injection on pterygium Combination of topical antazoline and tetrahydrozoline four times a day
Intervention Type
Drug
Intervention Name(s)
Topical antihistamine and vasoconstrictor
Other Intervention Name(s)
Hista-oph
Intervention Description
combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%
Primary Outcome Measure Information:
Title
percentage of corneal pterygium area
Description
Prior to receive the treatments, patients were asked to evaluate grading of their own symptoms and underwent clinical grading of the elevation and inflammation of the lesions using slit lamp biomicroscopy by an opthalmologist (OE). Digital photographs of each eye with pterygium were obtained for corneal pterygium area analysis [Sony Mavica digital still camera MVC-FD83, Japan]. Each patient was randomly assigned into either treatment group or control group using computer-generated random numbers table. Number of patients with adverse events will be recorded.
Time Frame
3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary pterygium Exclusion Criteria: previous ocular surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olan Suwan-apichon, MD
Phone
+66 43 348383
Email
osuwanapichon@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olan Suwan-apichon, md
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind Hospital
City
Mueng
State/Province
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olan Suwan-apichon, MD

12. IPD Sharing Statement

Learn more about this trial

Intralesional Bevacizumab Injection on Primary Pterygium

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