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Topical IL-1-Ra for Treatment of Corneal Neovascularization

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00915590
First received: June 4, 2009
Last updated: May 5, 2017
Last verified: May 2017

June 4, 2009
May 5, 2017
April 2009
March 2011   (Final data collection date for primary outcome measure)
  • Incidence and Severity of Ocular Adverse Event [ Time Frame: 64 Weeks ]
    Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
  • Extent of Neovascular Area (NA) [ Time Frame: 64 weeks ]
    The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
  • Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels [ Time Frame: 64 Weeks ]
    The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
  • Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels [ Time Frame: 64 Weeks ]
    The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Changes in the extent of corneal NV at Week 6, 12, 24 and 64 by measurement of: Neovascular Area (NA) Vessel Caliber (VC) Invasion Area (IA) [ Time Frame: 64 Weeks ]
Complete list of historical versions of study NCT00915590 on ClinicalTrials.gov Archive Site
  • Best Spectacle-Corrected Visual Acuity (BSCVA) [ Time Frame: 64 weeks ]
    The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
  • Central Corneal Thickness [ Time Frame: 64 Weeks ]
    The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Best Spectacle-Corrected Visual Acuity (BSCVA) at Week-6, 12, 24, 64 and central corneal thickness at Week-6, 12, 24, 64 [ Time Frame: 64 weeks ]
Not Provided
Not Provided
 
Topical IL-1-Ra for Treatment of Corneal Neovascularization
Topical IL-1-Ra for Treatment of Corneal Neovascularization
The purpose of this study is to determine the effectiveness and safety of Interleukin-1-Receptor Antagonist eye drops for the treatment of corneal blood vessels.
Normally avascular, under many pathologic conditions, vessels may invade the cornea from the limbal vascular plexus. Infection, inflammation, ischemia, degeneration, or trauma, and the loss of the limbal stem cell barrier can cause corneal neovascularization. Growth of new vessels may result in corneal scarring, edema, lipid deposition, and inflammation that may alter visual acuity and is a leading cause of monocular visual impairment and blindness. Additionally, it results in the loss of immune response across the cornea, thereby worsening the prognosis of a subsequent penetrating keratoplasty (PK). Growth of new blood and lymphatic vessels from preexisting vessels are mediated by members of the vascular endothelial growth factor (VEGF) family. This study is designed to investigate whether Interleukin-1-Receptor Antagonist is a drug that is both safe and effective in blocking VEGF pathways, stopping new growth, and reducing old vessel growth.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Corneal Neovascularization
  • Drug: Placebo
    Custom eye drop eye three times a day in both eyes for a period of 6 weeks
  • Drug: IL-1Ra
    5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
    Other Name: Kineret
  • Experimental: Placebo first, then IL-1RA
    It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
    Interventions:
    • Drug: Placebo
    • Drug: IL-1Ra
  • Experimental: IL-1RA first, then Placebo
    It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
    Interventions:
    • Drug: Placebo
    • Drug: IL-1Ra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
March 2011
March 2011   (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
  • Patients with superficial or deep corneal NV that extends farther than 1 mm from the limbus
  • Patients are in generally good stable overall healthExclusion Criteria: • Has received treatment with anti-VEGF agents (topical, intraocular or systemic) within 30 days of study entry
  • Corneal or ocular surface infection within 30 days prior to study entry• Ocular or periocular malignancy
  • Contact lens (excluding bandage contact lens) use within 2 weeks prior to study entry
  • Persistent epithelial defect (>1mm and ≥14 days duration) within 2 weeks prior to study entry
  • Intravitreal or periocular steroids within 2 weeks prior to study entry
  • Change in dose/frequency of topical steroids and/or NSAIDs within 2 weeks prior to study entry
  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using contraception
  • Signs of current infection, including fever and current treatment with antibiotics
  • Participation in another simultaneous medical investigation or trial
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00915590
09-03-017
Protocol #09-03-017 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
No
Not Provided
Yes
Not Provided
Reza Dana, MD, Massachusetts Eye and Ear Infirmary
Reza Dana, MD
Not Provided
Principal Investigator: Reza Dana, MD, MPH, MSc Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
May 2017

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