Status:
COMPLETED
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Lead Sponsor:
Reza Dana, MD
Conditions:
Corneal Neovascularization
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00681889
Start Date
April 1 2008
End Date
September 1 2010
Last Update
November 8 2012
Active Locations (1)
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1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114