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Completed

NCT Number: NCT01686529

Bevacizumab for Primary Pterygium Treatment

The aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Instituto de Oftalmología

Mexico City, 06800, Mexico

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with primary pterygium

Exclusion criteria

  • Patients with diabetes mellitus
  • collagenopathies,
  • previous ocular surgeries,
  • pregnant or lactating patients

Treatment and study plan

Autoconjunctival grafting

Procedure

The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.

Subconjuntival bevacizumab injection

Drug

The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.

Other names: Avastin

Primary outcomes

  1. Pterygium recurrence

    Time frame: One point.

    The pterygium recurrence is evaluated at one year postoperative

Secondary outcomes

  1. Conjunctival ischemia

    Time frame: Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative

    Whiteness of conjunctival bed, that means absence of blood vessels

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

Conjunctival Autografting Alone or Combined With Subconjunctival Bevacizumab for Primary Pterygium Treatment.

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 18, 2012
Registry last updated
Dec 6, 2013

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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