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Completed

NCT Number: NCT01288404

Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.

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Key information

Conditions

Pterygium of the Conjunctiva and Cornea Corneal Diseases Eye Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ramathibodi Hospital

Bangkok, 10400, Thailand

About this study

  • Impending recurrent pterygium
  • Anti-VEGF therapy
  • Bevacizumab
  • Subconjunctival injection
  • Suppress neovascularization

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
  • Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment.
  • No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
  • No other ocular surface pathologies or coexisting ocular diseases.
  • No other ocular surgeries within the previous 6 months.
  • No history of allergy to the medications used in this study.
  • Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion criteria

  • Platelet disorders
  • Hypertension
  • Pregnant or lactating women

Treatment and study plan

Fluorometholone

Drug

topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks

Other names: FML eye drops

Bevacizumab

Drug

subconjunctival bevacizumab 1.25 mg/0.05mL

Other names: Avastin

Primary outcomes

  1. Severity of impending recurrent pterygium

    Time frame: 3 months

Secondary outcomes

  1. Visual analog scales

    Time frame: 3 months

  2. Adverse reactions

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 2, 2011
Registry last updated
Feb 2, 2011

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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