This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
  Purpose
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.

Condition Intervention Phase
Corneal Neovascularization Drug: Placebo Drug: IL-1Ra Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: Topical IL-1-Ra for Treatment of Corneal Neovascularization

Resource links provided by NLM:


Further study details as provided by Reza Dana, MD, Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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
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

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915590

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, MD, MPH, MSc Massachusetts Eye and Ear Infirmary
  More Information

Responsible Party: Reza Dana, MD, Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00915590     History of Changes
Other Study ID Numbers: 09-03-017
Protocol #09-03-017 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
Study First Received: June 4, 2009
Results First Received: October 2, 2012
Last Updated: May 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Neovascularization, Pathologic
Corneal Neovascularization
Metaplasia
Pathologic Processes
Corneal Diseases
Eye Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 21, 2017