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Topical Bevacizumab for Preventing Recurrent Pterygium

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01311960
First Posted: March 10, 2011
Last Update Posted: April 9, 2013
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.
Information provided by (Responsible Party):
Ngamjit Kasetsuwan, Chulalongkorn University
  Purpose
The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.

Condition Intervention Phase
Pterygium Bevacizumab VEGF Anti-VEGF Drug: bevacizumab eye drop 0.05% Drug: normal saline 0.9% Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ngamjit Kasetsuwan, Chulalongkorn University:

Primary Outcome Measures:
  • rate of recurrence after primary pterygium removal [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 3 months ]
    Local and systemic adverse events will be evaluated once a month. Number of participants with adverse events will be reported.


Enrollment: 24
Study Start Date: December 2010
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bevacizumab eye drop Drug: bevacizumab eye drop 0.05%
bevacizumab eye drop 0.05% will apply 4 times a day for 3 months
Other Name: Study arm
Experimental: placebo normal saline eye drop Drug: normal saline 0.9%
normal saline eye drop 0.9% will apply 4 times a day for 3 months.
Other Name: placebo arm

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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): NCT01311960


Locations
Thailand
Faculty of medicine, Chulalongkorn university
Pathumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Ngamjit Kasetsuwan, MD Chulalongkorn Universitiy
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ngamjit Kasetsuwan, Associated professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01311960     History of Changes
Other Study ID Numbers: IRB No. 227/53
First Submitted: December 1, 2010
First Posted: March 10, 2011
Last Update Posted: April 9, 2013
Last Verified: March 2011

Keywords provided by Ngamjit Kasetsuwan, Chulalongkorn University:
pterygium
recurrent pterygium
bevacizumab
VEGF
anti-VEGF

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Bevacizumab
Ophthalmic Solutions
Tetrahydrozoline
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents