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Intralesional Bevacizumab Injection on Primary Pterygium (bevacizumab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01380678
Recruitment Status : Unknown
Verified July 2010 by Khon Kaen University.
Recruitment status was:  Recruiting
First Posted : June 27, 2011
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:
Khon Kaen University

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.

Condition or disease Intervention/treatment Phase
Pterygium Inflammation Drug: Intralesional injection of bevacizumab Drug: Topical antihistamine and vasoconstrictor Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Intralesional Bevacizumab Injection on Primary Pterygium: Preliminary Results
Study Start Date : January 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: bevacizumab
intralesional bevacizumab injection
Drug: 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
Other Name: Avastin
Active Comparator: Topical antihistamine and vasoconstrictor
combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%
Drug: Topical antihistamine and vasoconstrictor
combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%
Other Name: Hista-oph



Primary Outcome Measures :
  1. percentage of corneal pterygium area [ Time Frame: 3 years ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary pterygium

Exclusion Criteria:

  • previous ocular surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380678


Contacts
Contact: Olan Suwan-apichon, MD +66 43 348383 osuwanapichon@hotmail.com

Locations
Thailand
Srinagarind Hospital Recruiting
Mueng, Khon Kaen, Thailand, 40000
Contact: Olan Suwan-apichon, MD         
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Olan Suwan-apichon, md Khon Kaen University

Responsible Party: Olan Suwan-apichon, Department of Ophthalmology, Faculty of medicine, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01380678     History of Changes
Other Study ID Numbers: KKU-1007
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: July 2010

Keywords provided by Khon Kaen University:
bevacizumab
pterygium
treatment
elevation

Additional relevant MeSH terms:
Inflammation
Pterygium
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Bevacizumab
Histamine Antagonists
Antazoline
Histamine H1 Antagonists
Tetrahydrozoline
Vasoconstrictor Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Respiratory System Agents