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

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ClinicalTrials.gov Identifier: NCT00769145
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Sonia Yoo, University of Miami

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

Condition or disease Intervention/treatment Phase
Corneal Neovascularization Drug: Ranibizumab Phase 1

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
Study Start Date : October 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ranibizumab
Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally
 Drug: Ranibizumab
0.5mg subconjunctival dose of ranibizumab 3 days prior to corneal transplantation and at the time of corneal transplantation (total 2 injections).
Other Name: Lucentis


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769145


Locations
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United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Genentech, Inc.
Investigators
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Principal Investigator: Sonia Yoo, MD Bascom Palmer Eye Institute
More Information
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Responsible Party: Sonia Yoo, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00769145     History of Changes
Other Study ID Numbers: 20071015
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Keywords provided by Sonia Yoo, University of Miami:
Corneal neovascularization
Ranibizumab
Corneal transplantation
Additional relevant MeSH terms:
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Corneal Neovascularization
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Corneal Diseases
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents