Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

Pterygium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115517
• Other study ID #: Pterygium Avastin study
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2010
• Last updated: December 7, 2015
• Start date: October 2010
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pterygium

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lyndon B. Johnson General Hospital	Houston	Texas
United States	Robert Cizik Eye Clinic	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Hermann Eye Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of bevacizumab as adjunctive therapy during pterygium surgery to prevent recurrence of pterygia.		1 year	No
Primary	Safety of intraoperative bevacizumab applied as adjunctive therapy during pterygium surgery.		1 year	Yes
Secondary	Complication rate		1 year	Yes
Secondary	Elapsed time to recurrence of pterygia		1 year	No
Secondary	Risk factors for pterygium recurrence		1 year	No