Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

The University of Texas System (UT)

Status and phase

Completed

Phase 2

Conditions

Pterygium

Treatments

Drug: Mitomycin C

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01115517

Pterygium Avastin study

Details and patient eligibility

About

This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.

Enrollment

51 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18 to 80
Presence of primary or recurrent pterygium
Pterygium grows greater than 2mm onto cornea from limbus (using slit lamp light beam to measure size)
Pterygium is inducing astigmatism greater than 1 diopter compared to the fellow eye (to be determined by automated keratometry and manifest refraction)
The pterygium is symptomatic (irritation, inflammation, strabismus, decreased visual acuity)

Exclusion criteria

Age less than 18
Age greater than 80
Any systemic rheumatologic or autoimmune disorder (autoimmune hepatitis, bullous pemphigoid, celiac disease, Crohn's disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, mixed connective tissue disease, pemphigus vulgaris, psoriasis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's disease, ulcerative colitis, vasculitis, Wegener's granulomatosus)
Women who are potentially child-bearing (no possibility of pregnancy for at least one month after surgery)
Any use within the past two months of topical eye drops other than artificial tears in the study eye
Any previous intravitreal injections of any medication in the study eye
Any previous use of systemic, topical, or intravitreal bevacizumab in either eye
Any history of subconjunctival injections in the study eye within the past year
Any history of scleral or corneal laceration in the study eye
Ocular surgery within the past 3 months in the study eye
History of scleral buckle placement in the study eye
History of glaucoma