Status:
COMPLETED
Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Corneal Neovascularization
Eligibility:
All Genders
18-110 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00769145
Start Date
October 1 2008
End Date
March 1 2012
Last Update
July 11 2017
Active Locations (1)
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1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136