Clinical trial NCT01736449: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pterygium
Keywords: pterygium
bevacizumab
recurrence of pterygium
Lead sponsor: Arrowhead Regional Medical Center
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: number of recurrent pterygia with postoperative bevacizumab
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
Study officials:
affiliation: Arrowhead Regional Medical Center
name: Keith Tokuhara, MD
role: PRINCIPAL_INVESTIGATOR
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