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Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

Primary Purpose

Pterygium

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Arrowhead Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring pterygium, bevacizumab, recurrence of pterygium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Arrowhead Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Pterygium Excision Alone

Pterygium Excision with Bevacizumab Injection

Arm Description

Outcomes

Primary Outcome Measures

number of recurrent pterygia with postoperative bevacizumab
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.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2012
Last Updated
November 26, 2012
Sponsor
Arrowhead Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01736449
Brief Title
Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management
Official Title
Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arrowhead Regional Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
pterygium, bevacizumab, recurrence of pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pterygium Excision Alone
Arm Type
Placebo Comparator
Arm Title
Pterygium Excision with Bevacizumab Injection
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Primary Outcome Measure Information:
Title
number of recurrent pterygia with postoperative bevacizumab
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Tokuhara, MD
Organizational Affiliation
Arrowhead Regional Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arrowhead Regional Medical Center
City
Colton
State/Province
California
ZIP/Postal Code
92624
Country
United States

12. IPD Sharing Statement

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Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

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