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Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01736449
First Posted: November 29, 2012
Last Update Posted: November 29, 2012
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):
Sonia Dhoot, Arrowhead Regional Medical Center
  Purpose
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
Pterygium Drug: Bevacizumab Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Sonia Dhoot, 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.
  Eligibility

Information from the National Library of Medicine

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

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
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): NCT01736449


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

Publications:

Responsible Party: Sonia Dhoot, Prinicipal Investigator, Arrowhead Regional Medical Center
ClinicalTrials.gov Identifier: NCT01736449     History of Changes
Other Study ID Numbers: IRB1108
First Submitted: November 21, 2012
First Posted: November 29, 2012
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by Sonia Dhoot, Arrowhead Regional Medical Center:
pterygium
bevacizumab
recurrence of pterygium

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents