Intralesional Bevacizumab Injection on Primary Pterygium

NCT ID: NCT01380678

Last Updated: 2011-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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To evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment

Conditions

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Pterygium Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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bevacizumab

intralesional bevacizumab injection

Group Type ACTIVE_COMPARATOR

Intralesional injection of bevacizumab

Intervention Type DRUG

single dose of 2 mg of bevacizumab intralesional injection on pterygium Combination of topical antazoline and tetrahydrozoline four times a day

Topical antihistamine and vasoconstrictor

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

Group Type ACTIVE_COMPARATOR

Topical antihistamine and vasoconstrictor

Intervention Type DRUG

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

Interventions

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Intralesional injection of bevacizumab

single dose of 2 mg of bevacizumab intralesional injection on pterygium Combination of topical antazoline and tetrahydrozoline four times a day

Intervention Type DRUG

Topical antihistamine and vasoconstrictor

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

Intervention Type DRUG

Other Intervention Names

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Avastin Hista-oph

Eligibility Criteria

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Inclusion Criteria

* primary pterygium

Exclusion Criteria

* previous ocular surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Department of Ophthalmology, Faculty of medicine, Khon Kaen University

Principal Investigators

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Olan Suwan-apichon, md

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

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Srinagarind Hospital

Mueng, Changwat Khon Kaen, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Olan Suwan-apichon, MD

Role: CONTACT

+66 43 348383

Facility Contacts

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Olan Suwan-apichon, MD

Role: primary

Other Identifiers

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KKU-1007

Identifier Type: -

Identifier Source: org_study_id

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