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Completed

NCT Number: NCT00768963

Ranibizumab for the Inhibition of Neovascularization in Pterygia

The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

About this study

As a secondary objective, this study also aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection in patients undergoing pterygium excision and to determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects will be eligible if the following criteria are met:
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Patient related considerations: All patients of both genders will be considered for enrollment.
  • Disease related considerations:
  • Patients with pterygia will be considered for enrollment if the pterygium meets standard pterygium excision criteria including encroachment into the visual axis
  • severe induced astigmatism
  • foreign body sensation unresponsive to medical therapy.

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from this study:

  • Pregnancy (positive pregnancy test)
  • Women seeking to become pregnant
  • Lactating women
  • Prior enrollment in the study
  • Prior glaucoma surgery in the region of the pterygium
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial

Treatment and study plan

ranibizumab

Drug

0.5 mg subconjunctival ranibizumab 3 days prior to surgery

Other names: Lucentis

Primary outcomes

  1. The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery.

    Time frame: 2 years

Secondary outcomes

  1. This study aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection and determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Oct 8, 2008
Registry last updated
Jul 11, 2017

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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