Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.

Detailed Description
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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.

Official Title
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Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)

Conditions
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Corneal Neovascularization

Intervention / Treatment
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* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 18 years old Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus Exclusion Criteria: Has received investigational therapy within 60 days prior to study entry Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry Concurrent use of systemic anti-VEGF agents Full thickness or lamellar keratoplasty within 90 days prior to study entry Ocular surface reconstruction within 90 days prior to study entry Other ocular surgeries within 90 days prior to study entry Corneal or ocular surface infection within 90 days prior to study entry Ocular or periocular malignancy Contact lens (excluding bandage contact lens) within 30 days prior to study entry Persistent epithelial defect (>1mm2 and ≥14 days duration) within 30 days prior to study entry Systemic, intravitreal, or periocular steroids within 30 days prior to study entry Change in dose/frequency of topical steroids and/or NSAIDs within 30 days prior to study entry Hypertension: systolic BP > 150 or diastolic BP > 90 History of thromboembolic event within 6 months prior to study entry Current diagnosis of diabetes, Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception (The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch) Participation in another simultaneous medical investigation or trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>10 Patients will receive treatment (Ranibizumab) | Drug: Ranibizumab<br>* 10 Patients will receive treatment (Ranibizumab)<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and Severity of Ocular Adverse Event | Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing | 16 Weeks | 
| Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs |  | 16 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs |  | Prospective | 
| Efficacy by Measuring Mean Change of BCVA |  | Prospective |