Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery
Condition: Pterygium
MeSH terms: Pterygium
Intervention: Bevacizumab; Mitomycin C
Intervention description: 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.; 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.
Intervention MeSH terms: Bevacizumab; Mitomycins; Mitomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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