Phase 1
Completed N=9
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Source: ClinicalTrials.gov NCT00681889 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Incidence and Severity of Ocular Adverse Event — 0 participants
Summary
The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Ocular Adverse Event |
— | — |
| PRIMARY Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs |
— | — |
| SECONDARY Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs |
— | — |
| SECONDARY Efficacy by Measuring Mean Change of BCVA |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00681889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.