Topical Bevacizumab for Preventing Recurrent Pterygium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ngamjit Kasetsuwan, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01311960
First received: December 1, 2010
Last updated: April 6, 2013
Last verified: March 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Chulalongkorn University:

Primary Outcome Measures:
  • rate of recurrence after primary pterygium removal [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Ngamjit Kasetsuwan, Associated professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01311960     History of Changes
Other Study ID Numbers: IRB No. 227/53
Study First Received: December 1, 2010
Last Updated: April 6, 2013
Health Authority: Thailand: Ethical Committee

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

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

ClinicalTrials.gov processed this record on September 16, 2014