Treatment of Corneal Neovascularization With Topical Pazopanib
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Topical Pazopanib in Treatment of Corneal Neovascularization|
- Ocular Adverse Events [ Time Frame: 12 Weeks of follow-up ] [ Designated as safety issue: Yes ]Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing through week 12
- Non-Ocular (Systemic) Adverse Events [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs (blood pressure and heart rate) through week 12
- Corneal Neovascular Area [ Time Frame: Through 12 weeks of Follow-Up ] [ Designated as safety issue: No ]Changes in neovascular area: measuring the area of the corneal vessels.
- Corneal Vessel Caliber [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Change in vessel caliber: measuring the mean diameter of the corneal vessels.
- Corneal Invasion Area [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Change in invasion area: measuring the fraction of the total corneal area invaded by the vessels.
- Corneal Vessel Length [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]Change in Vessel Length: defined as the mean measurement of the extent of vessels from end to end.
|Study Start Date:||November 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.
Drug: Pazopanib (5mg/ml)
Topical pazopanib, 4 times per day for 3 weeks
Other Name: Votrient
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. In previous studies, inhibition of new blood or lymphatic vessels has been achieved by neutralization of vascular endothelial growth factor A (VEGF-A). It has also been shown that platelet-derived growth factor-B (PDGF-B) plays a role in corneal and choroidal neovascularization by regulating mural cell recruitment. Inhibition of PDGF-B and VEGF-A signaling pathways has shown to more effectively promote vessel regression than solely inhibiting VEGF-A. Pazopanib is a drug designed to block these pathways, stop new growth, and regress old vessel growth.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257750
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Reza Dana, MD, MPH, MSc||Mass Eye and Ear Infirmary|