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Topical IL-1-Ra for Treatment of Corneal Neovascularization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00915590
First received: June 4, 2009
Last updated: April 19, 2012
Last verified: April 2012

June 4, 2009
April 19, 2012
April 2009
March 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00915590 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
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 topical Interleukin-1-Receptor Antagonist in treatment of corneal neovascularization.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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
  • Experimental: Treatment Arm 1
    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: Treatment Arm 2
    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.
 
Completed
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00915590
09-03-017
Not Provided
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
Not Provided
Not Provided
Massachusetts Eye and Ear Infirmary
April 2012

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