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

University of Miami

Status and phase: Completed; Phase 1

Conditions: Corneal Neovascularization

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00769145

20071015

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Ranibizumab

Experimental group

Description:

Patients to receive two injections of 0.5 mg ranibizumab subconjunctivally

Treatment:

Drug: Ranibizumab