Overview

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

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Reza Dana, MD
Treatments:
Ranibizumab
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.