Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery

Conditions

• Pterygium

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• Bevacizumab — 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 — 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.

Study Details

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.

Key Dates

First listed

May 4, 2010

Start date

Oct 31, 2010

Status verified

Sep 2016

Primary completion

Jul 31, 2015

Completion

Jul 31, 2015

Study Design

Enrollment

51 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bevacizumab
• Active Comparator: Mitomycin C

Primary Outcome Measure

Number of Participants Who Had Recurrence of Pterygia up to 1 Year [ Time Frame: 1 year ]

Locations (2)

Find similar trials in Houston, TX