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

NCT ID: NCT00769145

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-03-31

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.

Conditions

Corneal Neovascularization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranibizumab

Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally

Group Type: EXPERIMENTAL

Ranibizumab

Intervention Type: DRUG

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

Interventions

Ranibizumab

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

Intervention Type: DRUG

Other Intervention Names

Lucentis

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sonia Yoo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sonia Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Bascom Palmer Eye Institute

Locations

Bascom Palmer Eye Institute

Miami, Florida, United States

Countries

United States

Other Identifiers

20071015

Identifier Type: -

Identifier Source: org_study_id