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Completed

NCT Number: NCT01115517

Safety Study of Avastin Used as Adjunctive Therapy 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.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lyndon B. Johnson General Hospital, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Bevacizumab (Avastin)

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.

Primary outcomes

  1. Number of Participants Who Had Recurrence of Pterygia up to 1 Year

    Time frame: 1 year

Secondary outcomes

  1. Number of Participants Who Had Complications From the Time of Treatment to Recurrence

    Time frame: 1 year

  2. Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Hermann Eye Center

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
May 4, 2010
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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