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

November 21, 2012
November 26, 2012
April 2011
April 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01736449 on ClinicalTrials.gov Archive Site
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Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management
Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pterygium
Drug: Bevacizumab
  • Placebo Comparator: Pterygium Excision Alone
  • Experimental: Pterygium Excision with Bevacizumab Injection
    Intervention: Drug: Bevacizumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01736449
IRB1108
No
Sonia Dhoot, Arrowhead Regional Medical Center
Arrowhead Regional Medical Center
Not Provided
Principal Investigator: Keith Tokuhara, MD Arrowhead Regional Medical Center
Arrowhead Regional Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP