Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonia Dhoot, Arrowhead Regional Medical Center
ClinicalTrials.gov Identifier:
NCT01736449
First received: November 21, 2012
Last updated: November 26, 2012
Last verified: November 2012
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
Study First Received: November 21, 2012
Last Updated: November 26, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014