Clinical trial NCT00769145: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Corneal Neovascularization
Keywords: Corneal neovascularization
Ranibizumab
Corneal transplantation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2008-10-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: Bascom Palmer Eye Institute
name: Sonia Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References: