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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00681889
First received: May 19, 2008
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Corneal Neovascularization
 Drug: Ranibizumab
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Incidence and Severity of Ocular Adverse Event [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
  • Efficacy by Measuring Mean Change of BCVA [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: April 2008
Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
10 Patients will receive treatment (Ranibizumab)
 Drug: Ranibizumab
10 Patients will receive treatment (Ranibizumab)
Other Name: Lucentis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681889

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Reza Dana, MD
Investigators
Principal Investigator: Reza Dana, M.D., MPH Massachusetts Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: Reza Dana, MD, Professor of Ophthalmology, Massachusetts Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT00681889     History of Changes
Other Study ID Numbers: 07-11-069, 07-11-069
Study First Received: May 19, 2008
Results First Received: October 10, 2012
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neovascularization, Pathologic
Corneal Neovascularization
Metaplasia
 Pathologic Processes
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013