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

Phase 1

Completed

• Conditions: Corneal Neovascularization
• Interventions: Drug: Ranibizumab

• Registration Number: NCT00681889
• Lead Sponsor: Reza Dana, MD

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2009-09
• Study Completion: 2010-09
• Status Verified: 2012-10
• Results First Submitted: 2012-10-10
• Results First Submitted QC: 2012-10-10
• Last Update Submitted: 2012-10-10
• Results First Posted: 2012-11-08
• Last Update Posted: 2012-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Ranibizumab	10 Patients will receive treatment (Ranibizumab)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States