Topical IL-1-Ra for Treatment of Corneal Neovascularization (NCT00915590) | Clinical Trial Compass
TerminatedPhase 1/2
Topical IL-1-Ra for Treatment of Corneal Neovascularization
United States10 participantsStarted 2009-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Incidence and Severity of Ocular Adverse Event
Timeframe: 64 Weeks
2
Extent of Neovascular Area (NA)
Timeframe: 64 weeks
3
Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels
Timeframe: 64 Weeks
4
Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels