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

Reza Dana, MD

Status and phase

Completed

Phase 1

Conditions

Corneal Neovascularization

Treatments

Drug: Ranibizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00681889

07-11-069 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.