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

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

Study Overview

• Status: Completed
• Conditions: Corneal Neovascularization
• Intervention / Treatment: Drug: Ranibizumab

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 10 Patients will receive treatment (Ranibizumab)	Drug: Ranibizumab; 10 Patients will receive treatment (Ranibizumab); Other Names: Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of Ocular Adverse Event	Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing	16 Weeks
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs		16 Weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Reza Dana, MD

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: May 19, 2008
• First Submitted That Met QC Criteria: May 20, 2008
• First Posted (Estimate): May 21, 2008

Study Record Updates

• Last Update Posted (Estimate): November 8, 2012
• Last Update Submitted That Met QC Criteria: October 10, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Corneal Diseases; Metaplasia; Neovascularization, Pathologic; Corneal Neovascularization; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: 07-11-069 (Other Identifier: Massachusetts Eye and Ear Infirmary)