Corneal Neovascularization
Conditions
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.
Interventions
DRUGRanibizumab
10 Patients will receive treatment (Ranibizumab)
Sponsors
Reza Dana, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Ocular Adverse Event | 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 | 16 Weeks | — |
Secondary
| Measure | 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 |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the Cornea Service at the Massachusetts Eye and Ear Infirmary from April 2008 through September 2009.
Pre-assignment details
Participants were assigned to the investigational treatment upon a full eligibility screening. Participants were not eligible if they had received investigational therapy within 60 days, received treatment with anti-VEGF agents (intraocular or systemic) within 45 days, were concurrently using systemic anti-VEGF agents amongst other criteria.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm 10 Patients will receive treatment (Ranibizumab)
Ranibizumab : 10 Patients will receive treatment (Ranibizumab) | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age Continuous | 57.3 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Incidence and Severity of Ocular Adverse Event
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing
Time frame: 16 Weeks
Population: All participants enrolled into the study were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm | Incidence and Severity of Ocular Adverse Event | 0 participants |
Primary
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs
Time frame: 16 Weeks
Secondary
Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs
Time frame: Prospective
Secondary
Efficacy by Measuring Mean Change of BCVA
Time frame: Prospective