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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
Endpoint Classification: Safety Study
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:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:   Both
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
Health Authority: United States: Food and Drug Administration

Keywords provided by 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 September 26, 2016