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

NCT00769145 | Completed Phase 1

• 1 other identifier: 20071015
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Neovascularization

Keywords

Corneal neovascularization; Ranibizumab; Corneal transplantation

Outcome Measures

Primary Outcomes (1)

• The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing corneal transplantation.

  2 years

Secondary Outcomes (1)

• 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.

  2 years

Study Arms (1)

Ranibizumab

EXPERIMENTAL

Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

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

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Corneal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sonia Yoo, MD

  Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

US (1)