Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Assess Safety and Efficacy of Intraoperative Topical Mitomycin C and Bevacizumab (Avastin) Applied to Bare Sclera in Pterygium Surgery

Conditions
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Pterygium

Intervention / Treatment
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* Drug: Bevacizumab
* Drug: Mitomycin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br> | Drug: Bevacizumab<br>* 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.<br>* Other names: Bevacizumab (Avastin);|
| Active Comparator: Mitomycin C<br> | Drug: Mitomycin C<br>* Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Recurrence of Pterygia up to 1 Year |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Complications From the Time of Treatment to Recurrence |  | 1 year | 
| Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year |  | 1 year |