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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

May 19, 2008
October 10, 2012
April 2008
September 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
  • 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 ]
Complete list of historical versions of study NCT00681889 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Corneal Neovascularization
Drug: Ranibizumab
10 Patients will receive treatment (Ranibizumab)
Other Name: Lucentis
Experimental: Treatment Arm
10 Patients will receive treatment (Ranibizumab)
Intervention: Drug: Ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
September 2010
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681889
07-11-069, 07-11-069
No
Reza Dana, MD, Massachusetts Eye & Ear Infirmary
Reza Dana, MD
Not Provided
Principal Investigator: Reza Dana, M.D., MPH Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP