Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Pterygium
• Intervention / Treatment: Drug: Bevacizumab; Drug: Mitomycin C

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77026
      • Lyndon B. Johnson General Hospital
    • Houston, Texas, United States, 77030
      • Robert Cizik Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bevacizumab	Drug: Bevacizumab; 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.; Other Names: Bevacizumab (Avastin)
Active Comparator: Mitomycin C	Drug: Mitomycin C; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Hermann Eye Center
• Investigators: Principal Investigator: Nan Wang, MD, PhD, University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Pterygium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antibiotics, Antineoplastic; Bevacizumab; Mitomycins; Mitomycin
• Other Study ID Numbers: Pterygium Avastin study