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OpenTrials
Completed

NCT Number: NCT00769145

Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery

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

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Key information

Conditions

Corneal Neovascularization Corneal Diseases Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–110 year

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 corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally at the limbus in patients undergoing corneal transplantation. The effects of ranibizumab on corneal epithelial healing will be examined following adjunctive use in corneal transplantation. Finally, clinical characteristics including recurrent corneal neovascularization will be studied.

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 meeting accepted criteria for undergoing corneal transplantation will be considered if peripheral corneal neovascularization exists in 2 or more contiguous clock hours

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 corneal neovascularization
  • 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

0.5mg subconjunctival dose of ranibizumab 3 days prior to corneal transplantation and at the time of corneal transplantation (total 2 injections).

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 corneal transplantation.

    Time frame: 2 years

Secondary outcomes

  1. This study also aims to establish the corneal and anterior chamber concentration of ranibizumab when delivered subconjunctivally. The effects of ranibizumab on corneal epithelial healing and prevention of recurrent neovascularization will be examined.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Genentech, Inc.

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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