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

Corneal Neovascularization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681889
• Other study ID #: 07-11-069
• Secondary ID: 07-11-069
• Status: Completed
• Phase: Phase 1
• First received: May 19, 2008
• Last updated: October 10, 2012
• Start date: April 2008
• Est. completion date: September 2010

Study information

• Verified date: October 2012
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• Ranibizumab
10 Patients will receive treatment (Ranibizumab)

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Reza Dana, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs		16 Weeks	Yes
Secondary	Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs		Prospective	Yes
Secondary	Efficacy by Measuring Mean Change of BCVA		Prospective	Yes