Clinical trial NCT01115517: Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pterygium
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Hermann Eye Center
First posted: 2010-05-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants Who Had Recurrence of Pterygia up to 1 Year
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants Who Had Complications From the Time of Treatment to Recurrence
timeFrame: 1 year
measure: Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: Robert Cizik Eye Clinic
state: Texas
Study officials:
affiliation: University of Texas at Houston Health Science Center, Robert Cizik Eye Clinic
name: Nan Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: