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Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

This study has been completed.
Information provided by (Responsible Party):
Sonia Dhoot, Arrowhead Regional Medical Center Identifier:
First received: November 21, 2012
Last updated: November 26, 2012
Last verified: November 2012
A pterygium is a fibrovascular growth originating from the conjunctiva that grows onto the surface of the cornea. Frequently, these pterygia will recur even after surgical resection. Bevacizumab is an inhibitor of angiogenesis, which is needed for recurrent growth. The use of bevacizumab is poorly understood in inhibiting pterygium growth. The objective of this study is to compare the effects of wound healing and recurrence rates in postoperative bevacizumab versus pterygium excision alone.

Condition Intervention Phase
Drug: Bevacizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

Resource links provided by NLM:

Further study details as provided by Arrowhead Regional Medical Center:

Primary Outcome Measures:
  • number of recurrent pterygia with postoperative bevacizumab [ Time Frame: 6 months ]
    The number of recurrent pterygia with patients who received bevacizumab after pterygium excision was compared to the number of recurrences in those patients who only had pterygium excision.

Enrollment: 31
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Pterygium Excision Alone
Experimental: Pterygium Excision with Bevacizumab Injection Drug: Bevacizumab

Detailed Description:
This is a prospective trial. Thirty-one patients with a primary pterygium of at least 2 mm in size and without any previous ocular surgery will be included. Outcome measures will include best corrected visual acuity, intraocular pressure, recurrence, and any sight threatening complications at two weeks, two months, and six months postoperatively.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • any patient 18 years of age or older with a primary pterygium that extends at least 2 mm past the limbus

Exclusion Criteria:

  • history of glaucoma
  • previous ocular surgery
  • steroid-response glaucoma
  • previous myocardial infarct
  • bleeding disorder
  • pregnancy
  • lack of patient cooperation
  Contacts and Locations
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Please refer to this study by its identifier: NCT01736449

United States, California
Arrowhead Regional Medical Center
Colton, California, United States, 92624
Sponsors and Collaborators
Arrowhead Regional Medical Center
Principal Investigator: Keith Tokuhara, MD Arrowhead Regional Medical Center
  More Information


Responsible Party: Sonia Dhoot, Prinicipal Investigator, Arrowhead Regional Medical Center Identifier: NCT01736449     History of Changes
Other Study ID Numbers: IRB1108
Study First Received: November 21, 2012
Last Updated: November 26, 2012

Keywords provided by Arrowhead Regional Medical Center:
recurrence of pterygium

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on May 24, 2017