Back to resultsRanibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
Primary Purpose
Corneal Neovascularization
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Neovascularization focused on measuring Corneal neovascularization, Ranibizumab, Corneal transplantation
Eligibility 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
Sites / Locations
- Bascom Palmer Eye Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ranibizumab
Arm Description
Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally
Outcomes
Primary Outcome Measures
The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00769145
First Posted
October 7, 2008
Last Updated
July 7, 2017
Sponsor
University of Miami
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00769145
Brief Title
Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
Official Title
Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Neovascularization
Keywords
Corneal neovascularization, Ranibizumab, Corneal transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
0.5mg subconjunctival dose of ranibizumab 3 days prior to corneal transplantation and at the time of corneal transplantation (total 2 injections).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Yoo, MD
Organizational Affiliation
Bascom Palmer Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
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