Clinical Trial: Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Brief Summary: The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.
Detailed Summary: This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.
Sponsor: Reza Dana, MD
Current Primary Outcome:
- Incidence and Severity of Ocular Adverse Event [ Time Frame: 16 Weeks ]Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing
- Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs [ Time Frame: 16 Weeks ]
Original Primary Outcome:
- Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing [ Time Frame: 16 Weeks ]
- Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs [ Time Frame: 16 Weeks ]
Current Secondary Outcome:
- Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs [ Time Frame: Prospective ]
- Efficacy by Measuring Mean Change of BCVA [ Time Frame: Prospective ]
Original Secondary Outcome: Same as current
Information By: Massachusetts Eye and Ear Infirmary
Dates:
Date Received: May 19, 2008
Date Started: April 2008
Date Completion:
Last Updated: October 10, 2012
Last Verified: October 2012
