Role of Sub-Conjunctival Bevacizumab in Post Pterygium Excision Management

Arrowhead Regional Medical Center

Status and phase: Completed; Phase 4

Conditions: Pterygium

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01736449

IRB1108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups, including a placebo group

Pterygium Excision Alone

Placebo Comparator group

Pterygium Excision with Bevacizumab Injection

Experimental group

Treatment:

Drug: Bevacizumab