Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

Condition(s) targeted: Pterygium

Intervention: Bevacizumab (Drug); Mitomycin C (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: The University of Texas Health Science Center, Houston

Official(s) and/or principal investigator(s):
Nan Wang, MD, PhD, Principal Investigator, Affiliation: University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Efficacy of bevacizumab as adjunctive therapy during pterygium surgery to prevent recurrence of pterygia.

Safety of intraoperative bevacizumab applied as adjunctive therapy during pterygium surgery.

Secondary outcome:

Complication rate

Elapsed time to recurrence of pterygia

Risk factors for pterygium recurrence

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Lyndon B. Johnson General Hospital, Houston, Texas 77026, United States

Robert Cizik Eye Clinic, Houston, Texas 77030, United States

Starting date: October 2010
Last updated: June 4, 2015