Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

NCT ID: NCT01115517

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-07-31

Brief 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.

Conditions

Pterygium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bevacizumab

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Mitomycin C

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Bevacizumab (Avastin)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hermann Eye Center

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Nan Wang

Clinical Associate Professor - Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nan Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic

Locations

Lyndon B. Johnson General Hospital

Houston, Texas, United States

Robert Cizik Eye Clinic

Houston, Texas, United States

Countries

United States

Other Identifiers

Pterygium Avastin study

Identifier Type: -

Identifier Source: org_study_id