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

Primary Purpose

Corneal Neovascularization

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
Reza Dana, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Neovascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

10 Patients will receive treatment (Ranibizumab)

Outcomes

Primary Outcome Measures

Incidence and Severity of Ocular Adverse Event
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

Secondary Outcome Measures

Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs
Efficacy by Measuring Mean Change of BCVA

Full Information

First Posted
May 19, 2008
Last Updated
October 10, 2012
Sponsor
Reza Dana, MD
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1. Study Identification

Unique Protocol Identification Number
NCT00681889
Brief Title
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Official Title
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Reza Dana, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
10 Patients will receive treatment (Ranibizumab)
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
10 Patients will receive treatment (Ranibizumab)
Primary Outcome Measure Information:
Title
Incidence and Severity of Ocular Adverse Event
Description
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing
Time Frame
16 Weeks
Title
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs
Time Frame
Prospective
Title
Efficacy by Measuring Mean Change of BCVA
Time Frame
Prospective

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Dana, M.D., MPH
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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