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Clinical Trials/NCT01736449
NCT01736449CompletedPhase 4

Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

Arrowhead Regional Medical Center1 site in 1 country31 target enrollmentStarted: April 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
31
Locations
1
Primary Endpoint
number of recurrent pterygia with postoperative bevacizumab

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Pterygium Excision with Bevacizumab Injection

Experimental

Intervention: Bevacizumab (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sonia Dhoot

Prinicipal Investigator

Arrowhead Regional Medical Center

Study Sites (1)

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