Intralesional Bevacizumab Injection on Primary Pterygium (bevacizumab)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Khon Kaen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01380678
First received: June 14, 2010
Last updated: July 7, 2011
Last verified: July 2010
  Purpose

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 Intervention Phase
Pterygium
Inflammation
Drug: Intralesional injection of bevacizumab
Drug: Topical antihistamine and vasoconstrictor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Intralesional Bevacizumab Injection on Primary Pterygium: Preliminary Results

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • percentage of corneal pterygium area [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 206
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary pterygium

Exclusion Criteria:

  • previous ocular surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 14, 2010
Last Updated: July 7, 2011
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Khon Kaen University:
bevacizumab
pterygium
treatment
elevation

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

ClinicalTrials.gov processed this record on September 30, 2014