Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Primary Purpose
Corneal Neovascularization
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Neovascularization
Eligibility Criteria
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.
Sites / Locations
- Massachusetts Eye and Ear Infirmary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
10 Patients will receive treatment (Ranibizumab)
Outcomes
Primary Outcome Measures
Incidence and Severity of Ocular Adverse Event
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
Secondary Outcome Measures
Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs
Efficacy by Measuring Mean Change of BCVA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00681889
Brief Title
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Official Title
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Reza Dana, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
10 Patients will receive treatment (Ranibizumab)
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
10 Patients will receive treatment (Ranibizumab)
Primary Outcome Measure Information:
Title
Incidence and Severity of Ocular Adverse Event
Description
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing
Time Frame
16 Weeks
Title
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs
Time Frame
Prospective
Title
Efficacy by Measuring Mean Change of BCVA
Time Frame
Prospective
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Dana, M.D., MPH
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
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