Treatment of Corneal Neovascularization With Topical Pazopanib

NCT01257750 | Completed Phase 1 Results

• 1 other identifier: 10-09-063
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Corneal Neovascularization

Keywords

corneal neovascularization; pazopanib; votrient; rosacea

Outcome Measures

Primary Outcomes (4)

• Heart Rate

  Heart rate through was measured throughout the study to assess subjects for systemic adverse events.

  12 Weeks

• Mean Arterial Pressure

  Mean arterial pressure was measured throughout the study to assess subjects for systemic adverse events..

  12 Weeks

• Central Corneal Thickness

  Pachymetry was used to measure the central corneal thickness of each study subject. Central corneal thickness was measured throughout the study to assess subjects for ocular adverse events.

  12 Weeks

• Intaocular Pressure

  Intaocular pressure is the measurement of pressure within the eye. Intaocular pressure was measured throughout the study to assess subjects for ocular adverse events.

  12 Weeks

Secondary Outcomes (4)

• Corneal Neovascular Area

  Through 12 weeks of Follow-Up

• Corneal Invasion Area

  12 Weeks

• Corneal Vessel Length

  12 Weeks

• Corneal Vessel Caliber

  12 Weeks

Study Arms (1)

Pazopanib

EXPERIMENTAL

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)

Interventions

Pazopanib (5mg/ml) DRUG

Topical pazopanib, 4 times per day for 3 weeks

Also known as: Votrient

Pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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 within 60 days prior to study entry
• Concurrent enrollment in another clinical investigational medicinal product or device study
• Concurrent use of anti-VEGF agents
• Corneal or ocular surface infection within 30 days prior to study entry
• Full thickness or lamellar keratoplasty within 90 days prior to study entry
• Other ocular surgeries within 60 days prior to study entry
• Ocular or periocular malignancy
• Soft 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 4 weeks prior to study entry
• Change in dose/frequency of topical steroids and/or nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study entry

Sponsors & Collaborators

• Reza Dana, MD: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Amparo F, Sadrai Z, Jin Y, Alfonso-Bartolozzi B, Wang H, Shikari H, Ciolino JB, Chodosh J, Jurkunas U, Schaumberg DA, Dana R. Safety and efficacy of the multitargeted receptor kinase inhibitor pazopanib in the treatment of corneal neovascularization. Invest Ophthalmol Vis Sci. 2013 Jan 17;54(1):537-44. doi: 10.1167/iovs.12-11032.

  PMID: 23233252 DERIVED

MeSH Terms

Conditions

Corneal Neovascularization; Rosacea

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Reza Dana, MD, MPH, MSc
• Organization: Massachusetts Eye and Ear Infirmary

Cornea_Research@meei.harvard.edu

617-573-3313

Study Officials

• Reza Dana, MD, MPH, MSc

  Mass Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: December 10, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 18, 2018
• Results First Posted: November 6, 2012

Record last verified: 2017-12

Locations

US (1)