Treatment of Corneal Neovascularization With Topical Pazopanib (NCT01257750) | Clinical Trial Compass
CompletedPhase 1/2
Treatment of Corneal Neovascularization With Topical Pazopanib
United States20 participantsStarted 2010-11
Plain-language summary
The purpose of this study is to determine the safety and efficacy of a drug \[Pazopanib (Votrient)\] as a treatment for corneal neovascularization. The cornea is the clear, central portion of the eye and neovascularization means blood vessel growth. The cornea is typically avascular, or without blood vessels. Corneal neovascularization in the cornea and can put vision at risk. Numerous diseases of the cornea such as inflammation, ischemia (restriction of blood supply), infection, degeneration (or deterioration), trauma, or corneal stem cell deficiency can lead to corneal neovascularization. This major ocular complication can lead to corneal scarring, edema (swelling), lipid deposits, and inflammation that may significantly alter your vision. In addition, it worsens the outcome of potential future treatments, such as a corneal transplant. A corneal transplant is a treatment that many patients with severe corneal disease may ultimately need.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability to provide written informed consent
* Ability to comply with study assessments and study requirements (for example, able to open the eye drop foil-wrap packaging and eye drop vials, willing to adhere to the daily dosing schedule) for the full duration of study
* Age \> 18 years
* Patients with superficial or deep corneal neovascularization that extends farther than 1 mm from the limbus
* Patients are in stable overall health
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase and bilirubin ≤ 1.5x upper limit of normal (ULN) or isolated bilirubin \>1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%
* Single QTcF \< 450 msec; or QTcF \< 480 msec in subjects with Bundle Branch Block
* A female is eligible to enter and participate in this study if she is of Non-childbearing potential (i.e., physiologically incapable of becoming pregnant),
Exclusion Criteria:
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* History of any clotting disorder, including predisposition to hypercoagulation or any previous thromboembolic event
* Major surgery within 1 month of screening
* Has received treatment with anti-VEGF agents (topical, intraocular or systemic) within 60 days of study entry. This includes both approved and investigational treatments.
* Has received investigational therapy wi…