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

This study has been completed.

Sponsor:

Collaborator:

Genentech, Inc.

Information provided by (Responsible Party):

Sonia Yoo, Bascom Palmer Eye Institute

ClinicalTrials.gov Identifier:

NCT00769145

First received: October 7, 2008

Last updated: July 24, 2012

Last verified: July 2012

History of Changes

Purpose

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	Intervention	Phase
Corneal Neovascularization	Drug: Ranibizumab	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery

Resource links provided by NLM:

MedlinePlus related topics: Corneal Disorders

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Sonia Yoo, Bascom Palmer Eye Institute:

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. [ Time Frame: 2 years ]

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. [ Time Frame: 2 years ]


Enrollment:	5
Study Start Date:	October 2008
Study Completion Date:	March 2012
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769145

Locations


United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136

Sponsors and Collaborators

Bascom Palmer Eye Institute

Genentech, Inc.

Investigators


Principal Investigator:	Sonia Yoo, MD	Bascom Palmer Eye Institute

More Information


Responsible Party:	Sonia Yoo, Professor, Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier:	NCT00769145 History of Changes
Other Study ID Numbers:	20071015
Study First Received:	October 7, 2008
Last Updated:	July 24, 2012

Keywords provided by Sonia Yoo, Bascom Palmer Eye Institute:


Corneal neovascularization Ranibizumab Corneal transplantation

Additional relevant MeSH terms:


Neovascularization, Pathologic Corneal Neovascularization Metaplasia Pathologic Processes Corneal Diseases Eye Diseases Ranibizumab	Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017

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